Introduction

For many people, pets are a major part of everyday life. They become part of their households and are like family, but like children, none of them come with true owner’s manuals. Sure, there are many books on the subject, but who do you trust? And who has the time to read all that stuff? What happens if or when they become sick or injured and need medication?

As a somewhat reticent parent of a very large Weimaraner (OK, my husband and daughter bought him without my knowledge), I was forced to learn rather quickly about the ins and outs of pet ownership. Still, he arrived, and we needed to determine what’s best for this 99-pound dufus, who amazingly survived eating an entire box of oatmeal raisin cookies. It wasn’t pretty, but that story is reserved for a different CE.

At the University of Connecticut School of Pharmacy and Pharmaceutical Sciences, advanced compounding students are trained in some veterinary compounding, but most pharmacy schools do not teach it. This is a bit upsetting since people spend millions of dollars on pets every year. An estimated 65.1 million households are home to dogs, and another 46.5 million households have cats in the United States (U.S.). With pet ownership comes the responsibility of caring for them. The average cost of veterinary care for a dog is $730 per year, with cats averaging $253 per year. The U.S. pet market is estimated to reach 165 billion in 2026.¹

Increasingly, pharmacy staff need to know some basics about companion animals and their health issues. Pet owners can request a paper prescription from the veterinarian and fill it at community pharmacies. The American Veterinary Medical Association (AVMA) incorporated prescription guidelines into their 1991 bylaws. It states that “a veterinarian shall honor a client's request for a prescription or veterinary feed directive in lieu of dispensing but may charge a fee for this service.”² What do you do when a pet owner brings a prescription to your pharmacy?

People’s perceptions about feeding human food to dogs and cats are surprising. An old wives’ tale, passed from generation to generation, tells us that dogs can eat just about anything, including bones. Most of us now know that sharp bone shards can penetrate the soft tissues at the back of the throat, they can lodge in the esophagus, or they can pierce the intestines. It is also possible for a piece of bone to lodge in the trachea (windpipe), interfering with a dog’s ability to breathe.³ The controversy still continues today, but no pet owner wants their pet to have broken teeth, mouth injuries, or intestinal blockages if they can avoid it. If cooked bones are out, what else is bad for them? Certain foods create a risk for most pets, so compounders must not use these items as ingredients in their compounds. Table 1 contains a list of some human foods that should be avoided in pets.

 

Table 1. Human Foods That Should Not Be Given to Pets4
Food Item	Type of Pet	Toxicity/Reasoning
Alcohol	Dogs, cats, chickens, rabbits	Alcohol poisoning
Tobacco	Dogs, cats	Nicotine
Onions, chives, garlic (Allium family)	Dogs, cats, chickens,  rabbits	Sulfates, disulfides
Avocado	Dogs, cats, chickens, horses, cows, pet birds	Persin
Salt	Dogs, cats, chickens	Fluid imbalance
Spicy foods	Dogs	G.I. upset
Grapes, raisins	Dogs, cats, rabbits	Kidney failure
Caffeine	Dogs, cats, rabbits	Methylxanthines
Chocolate	Dogs, cats, horses, rabbits	Theobromine and caffeine
Citrus fruits	Cats, chickens	Citric acid, essential oils
Cinnamon	Dogs, cats	Mouth and throat irritant
Nutmeg	Dogs, cats	Myristicin
Macadamia nuts	Dogs, cats	Toxicity unknown
Mushrooms	Dogs, cats	Mycotoxins
Green tomatoes, raw potatoes	Dogs, cats, chickens, horses, rabbits	Solanine
Raw bread dough, raw yeast, bread	Dogs, cats, horses, rabbits	G.I. upset, bloating, empty calories
Rhubarb	Chickens, rabbits
Dairy items, ice cream	Dogs, cats, chickens, horses, rabbits	High sugar, high fat, lactose intolerance. Adult cats become lactose intolerant
Sugar free gum and sugar free candy	Dogs	Xylitol
Seeds and pits	Dogs, cats, chickens, horses, rabbits	Cyanide
Turkey skin, chicken skin, ham	Dogs, cats, rabbits	High fat content, can cause acute pancreatitis
Marijuana	Dogs, Cats, Horses, rabbits	Tetrahydrocannabinol (THC)

 

Items like alcohol, tobacco, caffeine, and chocolate make sense. Alcohol and tobacco affect dogs and cats as they do humans, but our pets are much smaller, so it takes significantly less alcohol or tobacco to cause catastrophic events such as breathing problems, vomiting, diarrhea, coma, or even death. Dogs are curious, and a tobacco or marijuana “cigarette” on the ground might be pretty tasty. The average tobacco cigarette contains 10 to 12 milligrams of nicotine. A toxic dose of nicotine for a pet is 0.5 to 1 milligram per pound, and a 4-milligram dose per pound can be lethal.⁵ Doing some quick math, consuming as little as three or four cigarettes could be fatal to a 10-pound dog.

Vaping has become extremely popular, which has caused an increase in nicotine poisoning. An average 6 mL, 5% nicotine e-cigarette can contain up to 300 mg of nicotine. Pets can be subjected to nicotine poisoning by secondhand smoke, through spillage on skin, and by drinking vaping liquid. Consider this: a 40-pound dog would only need to be exposed to a 1 mL dose for it to become poisoned.⁵ Nicotine is not the only toxin in e-cigarettes. They also contain volatile organic compounds, heavy metals (e.g., cadmium, copper, lead, nickel, tin) and they contain propylene glycol. All of these components are harmful to pets.

Those other “cigarettes” can be pretty tasty too. Marijuana use is on the rise in the U.S. and as of September 9, 2026, it is legal in 42 states and the District of Columbia.  “Recreational drugs, including marijuana, remain among the ASPCA Animal Poison Control Center’s top 10 categories of substances involved in pet poisonings. The two major components of marijuana are cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC). HC is responsible for the characteristic marijuana toxicosis and products containing THC can cause clinically significant poisoning; CBD products can also pose risks, particularly because composition and THC contamination/concentration may vary. CBD is widely advertised for human and pet use, but consumers must read labels carefully. Most CBD products are not entirely pure. They contain small amounts of THC.⁶

Although secondhand smoke and consuming raw marijuana leaves can be toxic, the most reported intoxication comes from pets eating infused edibles. Edibles--like brownies, cookies or gummies--are made with concentrated THC infused oils or THC-infused butter. They tend to be a more significant threat since most edibles also contain chocolate or xylitol.⁷ If pets exhibit any symptoms, they should be taken to a veterinarian. THC poisoning closely mimics the signs of antifreeze poisoning which is fatal and an antidote needs to be given as quickly as possible.^6,7

Symptoms of marijuana intoxication can become visible within 30 to 60 minutes after ingestion. Pets may stumble and cross their feet, walking as if they were drunk, they may have enlarged pupils, become lethargic and flinch in reaction to sudden movements. Pets with severe cases of intoxication may vomit, have tremors, shake uncontrollably and in extreme cases become comatose. Roughly 50% of dogs develop urinary incontinence and dribble urine uncontrollably (which might make the drug less popular if this happened in humans).⁷

Some medications contain significant amounts of alcohol. If unsecured, a dog or cat could consume them. Certain formulations of diphenhydramine (Benadryl, Sominex), guaifenesin with codeine (Cheracol Plus), dextromethorphan, guaifenesin, pseudoephedrine combinations (Dimetane, Robitussin, Triaminic, Vicks), hydrocodone and pseudoephedrine combinations (Novahistine), and certain multivitamin liquids (Geritol) contain alcohol. Some remedies can contain up to 25% alcohol, which can harm pets (and children).⁸ Alcohol is sweet tasting to dogs, so they will not stop drinking it until it is all gone.

Caffeine and chocolate ingestion should also be taken seriously. Caffeine contains methylxanthines, which can cause bronchodilatory and stimulatory effects in humans. In animals, they can also cause vomiting, diarrhea, hyperactivity, seizures, and cardiac arrhythmias. Chocolate, derived from the roasted seeds of Theobroma cacao, contains methylxanthine theobromine and caffeine. The theobromine content in chocolate is three to ten times that of caffeine. Cats do not have taste buds that can detect sweetness, but dogs do have a sweet tooth and love the taste of chocolate. One ounce (28 grams) of chocolate could be a lethal dose in a small dog. Theobromine has a half-life of two to three hours in humans, but it is longer in dogs. The half-life of theobromine in dogs is 17.5 hours.^9,10 The SIDEBAR provides more information about chocolate toxicity in dogs.

 

How Much Chocolate is Too Much?

Different cocoa beans and chocolate products contain various amounts of methylxanthines. Compounders and veterinary care providers must consider the dog or cat’s weight and the amount of chocolate consumed.^10,11

Methylxanthine doses of 15 mg/kg (7.5 mg per lb.) or less should not harm a dog. This is equivalent to one square of dark chocolate for a 3 kg (6 lb.) dog or seven squares of chocolate for a 15 kg (33 lb.) dog. One square of chocolate is approximately 6 grams (0.21 oz). This formula calculates the dose consumed:

• Theobromine dose = concentration in type of chocolate x amount eaten/weight
• Caffeine dose = concentration in type of chocolate x amount eaten/weight
• Theobromine + caffeine = total methylxanthines

The caffeine and theobromine amount in the specific type of chocolate may be on the label, and Table 2 provides some information about common products.¹⁰ However, in emergencies, healthcare providers can use calculators on the Internet that perform this calculation quickly and efficiently. This is not to say that cats never get into chocolate and get sick. There are also cat chocolate toxicity calculators online in case of emergency.

Table 2. Methylxanthines in Chocolate¹⁰

Product	Methylxanthines per 1 gram chocolate	mg methylxanthines /ounce of chocolate
Dry cocoa powder	28.5 mg	800 mg
Unsweetened bakers chocolate	16 mg	450 mg
Milk chocolate bar	2.3 mg	64 mg
Dark chocolate bar	5.7 mg	150 - 160 mg
Cocoa bean hulls (mulch)	9.1 mg	225 mg
White chocolate	Negligible

 

Excess salt (sodium chloride) can cause fluid imbalances which could lead to seizures and spicy foods can cause painful vomiting, diarrhea, or stomach ulcers. Dogs, cats, and even birds are very sensitive to salt, so pet owners and compounders should be aware of common items that contain large amounts of salt. For example, sea water, baking soda, homemade play dough, and driveway deicer all contain high concentrations of salt. Sodium chloride poisoning in dogs are most often caused by pet owners who use salt to induce vomiting after the dog has ingested a different toxin. It is important to consult with a veterinarian or pet helpline before administering any type of antidote.¹²

Even seemingly harmless spices can be harmful. Cinnamon can cause mouth irritations and nutmeg, which contains myristicin, can cause hallucinations in smaller animals. Mushrooms contain mycotoxins which can also cause hallucinations, diarrhea, vomiting, or kidney failure and in extreme cases, liver failure.⁴

Although it is more toxic to cats than dogs, onions, chives, garlic, and all members of the allium family of herbs contain sulfoxides and disulfides, and an oxidant called n-propyl disulfide. These can cause fatal anemia, called oxidative hemolysis, which affects dogs, cats, rabbits and chicken. Signs of anemia may take several days to appear.^4,17,18 If a dog is fed a little garlic once in a while it should not be a problem, but garlic should not be intentionally used as a veterinary compounding ingredient or supplement without veterinary direction. It was once believed that garlic supplements given to dogs could help to repel fleas and ticks, but this has now been proven to be ineffective.¹³

Other problematic vegetables include green tomatoes, raw potatoes, and avocado. The tomato plant’s green parts, its stems and leaves, and raw potatoes contain solanine. Solanine is poisonous, even to humans. It has pesticide-like properties and is part of the plant’s natural defenses. Solanine can be found in green potatoes and potato tubers (eyes).¹⁴ It is also found in other members of the nightshade family (e.g., eggplant skin).

Avocado is only slightly dangerous to dogs and cats, but extremely dangerous to birds and large animals such as cows, goats, sheep, and horses. The bark, leaves, skin, pits, and fruit of the avocado contain persin, which is a fungicidal toxin. Persin is an oil soluble compound that seeps into the fruit from the large seed inside. It is similar in structure to a fatty acid, and is harmless to humans, but toxic to most animals. Symptoms of persin toxicity range from edema and mastitis to respiratory distress and heart failure.^15,16

Chickens, which are increasingly popular in backyards, are sensitive to many food items. They should not be fed most human foods, but especially avoid feeding them citrus fruits, uncooked rice and uncooked dried beans, fruit seeds and pits, tomato leaves, green potatoes, and rhubarb.¹⁷ Rhubarb’s high oxalic acid content binds to minerals and can form kidney stones. Although high in calcium and phosphorus, certain dried beans are acidic and contain hemagglutinin. Certain dried beans contain hemagglutinins, plant lectins that can bind to intestinal cells and interfere with normal gastrointestinal function, potentially causing vomiting, diarrhea, and other signs of toxicity.

Rabbits, guinea pigs, and most herbivores have similar dietary restrictions. Fruit seeds and pits contain small amounts of cyanide, which can be a concern to smaller animals. Cabbage, cauliflower, other gassy vegetables and iceberg lettuce must be avoided. Iceberg lettuce contains lactucarium. Lactucarium (also called lettuce opium), a milky fluid excreted near the base of the lettuce plant, has sedative properties. Rabbits and other herbivores should stick to darker greens.¹⁸

Factors That Influence Toxicity

Each species of animal reacts to toxins differently due to variations in absorption, metabolism, or elimination. The dose of toxin per body weight is a major concern. Other factors include the animal’s age, size, nutritional status, stress level, and overall health. For example, most young animals do not have a fully developed system of metabolism, which may cause a toxin to remain in their system longer, causing more harm. Horses, rabbits, and small rodents do not have the ability to vomit, which means that they may be poisoned at a lower dose.¹⁹

One must also consider the chemical nature of a food, drug, or poison that is consumed. If the drug or toxin dissolves in water easily, it will spread throughout the body easier. If there are substances added to an active ingredient, such as a binding agent or outer coating, or if it is a sustained release product, it will affect absorption.¹⁹ Overall, pharmacists should become familiar with species-specific toxins and the factors that affect the risk of toxicity. Animals absorb, distribute, metabolize, and eliminate medications and toxins differently from humans, and the interspecies differences are also notable. See the SIDEBAR for a list of the top ten toxic items.

 

SIDEBAR: ASPCA Poison Control: Top 10 Pet Toxins of 2025²⁰

Each year, ASPCA Poison Control reviews exposure data to identify the substances pets most commonly encounter. In 2025, ASPCA Poison Control received calls about more than 376,000 potentially toxic items to which pets were exposed.” In 2025, the top 10 categories were:

1. Over-the-counter medications and supplements — 16.9% of exposures; vitamins, supplements and skin care products were the most common.
2. Food and drink — 16.4%; common exposures included grapes, raisins, xylitol-containing gum, onions, and garlic
3. Human prescription medications — with cardiac medications most prevalent
4. Chocolate — 13.6% of exposures; ASPCA received approximately five calls per hour regarding chocolate.
5. Veterinary products — 9.1%; up from #7, flavored chewable products were a common source
6. Plants and fungi — 7.5%
7. Rodenticides — 6.5%
8. Household products — 6.4%; cleaners and paints were common exposures
9. Insecticides — 3.8%
10. Recreational drugs — 1.9%; including marijuana, psychedelic mushrooms, and increasingly, kratom (up 400%)

 

Evolution has influenced species-specific diets. Dogs have evolved to become opportunistic gorgers, while cats are very picky. A dog will eat every bit of chocolate once he starts, which is the reason why dog poisonings are more common. Cat poisoning is less common and are usually the result of intentional harm by human beings.

 

PAUSE AND PONDER: Have you tried to give a dog a tablet or capsule? Did you wrap it in some meat or cheese? How did you get that cat to take his dose?

 

When to Compound

Pharmacists should consider compounding veterinary products under three conditions:

1. When a commercial product is unavailable. This could be due to drug recalls, drug shortages, or because a commercial product has yet to be developed. In some cases, rapid changes in disease state management create an urgent need for medication.
2. When an approved drug needs to be modified. This would include an increase or decrease in dosage due to a lack of appropriate dosage size, or a lack of formulation for a desired route. For example, making a dilution, adding flavoring, or changing the form of the drug. A popular compounding task is changing a tablet into a suspension.
3. When the likelihood of nonadherence is high. Owners’ adherence is greater when they can administer one combination product instead of two or three. For example, combining two injectable vaccines or allergy medications into one syringe for ease of use would be helpful to the pet owner. Of course, it is also more beneficial to the animal, since it will minimize harm and stress, which will lead to a better prognosis. Our students have recently formulated a compound of ketoconazole, gentamicin sulfate, and mometasone furoate all in one for a dog with an external ear bacterial yeast infection.

Dogs and cats can be very particular, and their sense of smell will give that medication away every time. This means that compounding must be creative. The most popular forms of medications for veterinary consideration include capsules, transdermal medications, flavored liquids, tablets, chews, or treats. Oral formulations can be difficult to give, but devices such as droppers, mechanical pill injectors, oral syringes, and oral pastes and gels can mask medications. Pill pockets—soft, flexible treats—can be molded around a tablet or capsule. Medicated oral pastes and gels, when placed on a cat’s paw, are an ingenious way for the cat to lick his medicine up. Compounders make a variety of products from hairball pastes and pectin gels, used for diarrhea, to dental licks and probiotic powders which are placed on a cat’s fur.

Human compounding caters to the customer, and the same is true for pets. Tuna or salmon flavoring attracts cats; beef or chicken flavoring may fool dogs; and birds love seeds. Other ingredients can be rather generic. Compounders can choose from a myriad of thickeners, sweeteners, and preservatives. Choosing the correct excipient could be crucial.

 

PAUSE AND PONDER: Take another look at the list of forbidden foods. Which items on your pharmacy compounding shelf could be harmful to pets?

 

Ingredients for veterinary compounding

In human compounding we tend to lean toward avocado or grapeseed oil to soothe and treat the skin, which are lighter than other oils. We use alcohol, propylene glycol, polysorbate 80 (Tween 80), and essential oils in compounds and peanut butter quite often for dog treats. These may not be the best choices in some veterinary situations. Let’s look at what is safe and what should not be used for pets.

Sweeteners

Sugar substitutes are game changers for people who have diabetes or are on low calorie diets. Xylitol is a current human favorite, occurring naturally in small amounts in berries, cauliflower, corn, mushrooms, oats, plums, and pumpkins. In industrial production, the purest form is extracted from raw biomass materials such as hard and soft wood, and especially from the birch tree. More economical processing uses hydrolyzed, purified agricultural corn, wheat, and rice waste. Economists expect xylitol production to become a $1.4 billion industry by 2025.²¹ Why the increase in popularity? Xylitol contains two-thirds of the calories of sucrose and has a mildly increased saliva effect. Unfortunately, xylitol is extremely toxic to dogs.

When dogs consume xylitol, it is quickly released into the bloodstream, causing an immediate and potent release of insulin from the pancreas. This leads to severe hypoglycemia, with onsets that can occur anywhere from 10 to 60 minutes after ingestion. Without treatment, the dog may develop liver failure, have seizures, or become comatose.²²

Products that contain xylitol are ubiquitous. It’s found in foods such as barbeque sauce, candy, gum, jam, ketchup, low calorie maple syrup, and peanut butter (meaning that compounders who use peanut butter need to check labels carefully; xylitol may be listed as 1,4-anhydro-d-xylitol, anhydroxylitol, birch bark extract, birch sugar, D-xylitol, Xylite, xylitylglucoside, or zylatol). In fact, sugar-free gum is the most common source of xylitol poisoning in dogs. For example, one piece of gum or one breath mint can be fatal to a 10-pound dog. The Pet Poison Helpline responded to 5,846 xylitol poisoning cases in 2020.²²

Xylitol can also be found in many pharmaceuticals and personal care products: cough syrup, deodorant, digestive aids, gummy vitamins, laxatives, mouthwash, nasal sprays, shampoo, skin care products, sleep supplements, toothpaste, and especially orally dissolving tablets. Small traces of xylitol can even be found in prescription medications.²² Gabapentin tablets and capsules do not contain xylitol, but gabapentin oral solution contains xylitol. The SIDEBAR discusses one xylitol poisoning case.

 

SIDEBAR: POOR MIMI²³

In 2020, Mimi, a pet poodle passed away after receiving gabapentin. The veterinarian prescribed gabapentin oral solution, for ease of use and medication adherence for Mimi’s seizures. The owner administered the dose and Mimi’s seizures increased, so the owner called the veterinarian, who increased the dose of medication to be given. Within 24 hours Mimi was gone.

How could this happen?

Many veterinarians are unfamiliar with the added ingredients in human formulations. Also, drug manufacturers may change sweeteners without notice. A retail pharmacist filled her prescription for gabapentin oral solution with the commercially available product, which contained xylitol.  When the dog’s owners went to the pharmacy to investigate, they found several factors which caused the problem.

• They were told that the pharmacist did not know that the solution contained xylitol and he was also unaware that xylitol was harmful to dogs.
• The pharmacy had no drug utilization review processes in place for veterinary drugs.
• The existing built-in computer software was not programmed to issue alerts for xylitol or other veterinary toxins.
• The pharmacy did not have a veterinary drug reference book, for example, Plumbs Veterinary Medicine, or a veterinary drug formulary. Unfortunately, the majority of state boards of pharmacy do not require pharmacies to carry a veterinary drug reference book.

Pharmacists and pharmacy technicians need to be aware of additives in human drug formulations that can be harmful to pets. Mimi’s death could have been avoided.²³

 

PAUSE AND PONDER: Have you heard of birch sugar?

 

Many companies now list xylitol as birch sugar. Xylitol was first discovered and reported in 1891 by the German Nobel Prize winning chemist Emil Fischer. Fischer named the new compound xylit (the German word for xylitol), which is believed to stem from the Greek word xylon, whose English translation is xylem. Xylem constitutes the woody element of higher plants, such as the beech wood from which Fischer first isolated xylitol. Xylitol is a polyol sugar alcohol and is referred to as birch sugar because it can be produced from birch. Natural sources of xylitol include plums, strawberries, and raspberries. It may also be listed as birch sugar, or birch bark extract²⁴

Many other sugar substitutes are considered safe to use in veterinary compounding. Erythritol, a sugar used mainly in keto desserts and baked goods, is safe in small amounts. Stevia and aspartame are also considered safe to use, although pets may experience stomachaches or slight diarrhea. Saccharin (Sweet-n-Low), sucralose (Splenda), or monk fruit, a newer sweetener, are all considered safe in pets.²⁵ Dogs have more of a sweet tooth than cats, but in general, sweeteners should be kept to a minimum.

Flavors

Using an optimal flavor profile helps mask the active ingredient’s taste and will promote animal adherence. Compounders should use only flavorings that are intended for compounding use. They shouldn’t use meat-flavored bouillon cubes or bouillon powders for compounding since they contain high amounts of salt, onion powder, and other harmful spices. Table 3 lists common flavorings and the species that find them enjoyable.

 

Table 3. Common Flavorings for Pets^17,26

Animal	Flavor	Reasoning
Birds	Banana, grape, orange, raspberry, tangerine, tutti-frutti, pina colada	Birds prefer sweet and fruity flavors
Dogs	Bacon, beef, liver, chicken, turkey, cheese, peanut butter, molasses, caramel, anise, marshmallow, raspberry, strawberry, honey	Dogs prefer meats and sweets
Cats	Fish, liver, tuna, cod liver oil, sardines, mackerel, salmon, beef, chicken, cheese, bacon, molasses, peanut butter, butterscotch, marshmallow	Cats have little preference for sweetness but strongly dislike bitterness
Gerbil	Banana cream, orange, peach, tangerine, tutti-fruiti	Gerbils like sweet and fruity flavors
Iguana	Banana, cantaloupe, kiwi, orange, tangerine, watermelon, other melons	Iguanas and most reptiles, rely on their sense of smell more than taste, so it must smell good
Rabbits	Banana cream, carrot, celery, lettuce, parsley, pineapple, vanilla, butternut	Find their favorite vegetable or fruit and use it
Poultry	Cantaloupe, corn, meal, milk, vanilla, butternut, watermelon	Birds are more visually oriented. The color red appeals to them, berries are a good choice. Research is ongoing to determine the sense of taste in chickens

 

Preservatives and Additives

The Food and Drug Administration (FDA) maintains a list of additives generally recognized as safe (GRAS) for use in pet foods. Manufacturers must submit food additives used in their pet foods for FDA review, which if approved, are added to the GRAS list.²⁷

Still, many excipients should not be used for veterinary compounding ^28,29,32

• Butylated hydroxyanisole (BHA)
• Butylated hydroxytoluene (BHT)
• Ethoxyquin
• Propylene Glycol
• Polysorbate 80 (Tween 80)

BHA and BHT are preservatives that are added to oils and rendered fats in certain pet foods and treats. They have been found to be carcinogens and can cause liver and kidney damage in rats, but the FDA has cleared them for use in small amounts in pet foods and treats. Ethoxyquin, a preservative, is used as a hardening agent. It is also used in pesticides and rubber and is illegal for human use, yet the FDA has ruled the additive “may be safely used in animal feeds” when used according to regulations.²⁷ Which is the best preservative to use? The answer is to stick to more natural preservatives. Vitamin C and E are great choices, as are lemon, except for use in cats and chickens, and honey. Honey is packed with vitamins A, B, C, D, E, and K and also contains potassium, calcium, magnesium, copper, and antioxidants. Giving a pet a small amount of honey can even help to build immunity from some allergens, such as pollen.³⁰

Propylene glycol is a controversial excipient used as a humectant, or moisturizing agent, in many pharmaceutical formulations. Propylene glycol is frequently used as a substitute for ethylene glycol in low toxicity, environmentally friendly automotive antifreeze. Small amounts may be used in dog formulations, but it is extremely toxic to cats. Extended exposure to propylene glycol over several years has been shown to cause seizures and possible blood disorders in both dogs and cats.²⁹ Cats may develop Heinz body hemolytic anemia, which can lead to death.

Cats and dogs are also extremely reactive to essential oils. Popular essential oils (e.g., eucalyptus oil, peppermint oil, tea tree oil) can be found in some natural flea repellents, perfumes, and aromatherapy products. These are safe to use in humans and can be found in many topical preparations; using these oils in topical preparations for dogs or especially cats (since they are continual groomers), can be harmful. Signs of toxicity are lethargy, depression, ataxia, tremors, seizures, or death.³¹

Polysorbate 80 (Tween 80) is a surfactant used in soaps and as a lubricant in eye drops. It is also used as an excipient quite often to stabilize aqueous formulations of lipophilic drugs for vaccines and for parenteral administration. Many Chinese herbal injectable medications contain high amounts of polysorbate 80. When dogs are given intravenous (IV) medications that contain high levels of polysorbate 80, for example vitamin K, it causes systemic histamine release, which causes allergic reactions and tachycardia and may lead to an anaphylactic reaction.³²

Corn syrup is a cheap humectant, sweetener, and flavoring agent all-in-one, but it can increase blood sugar significantly in dogs. A vegetable-based glycerin, such as coconut glycerin is a better choice.³³

Food dyes and colorants should be used sparingly when compounding. Blue dye #2, Red #40, yellow #5 and #6 can cause hypersensitivity or allergic reactions in some pets. Also, caramel color 4-methylimidazole (4-MIE) is under investigation as a possible carcinogen in pets.³³ In actuality, pets do not care about the color of the compound. Artificial coloring only appeals to the pet owner.

 

When to Call a Professional

When should pet owners or concerned pharmacy staff call a professional for a suspected pet poisoning? The sooner the better. The first call should be to the pet’s veterinarian, but national hotlines are also available for emergencies 24/7 for a fee.

• ASPCA Animal Poison Control

https://www.aspca.org/pet-care/animal-poison-control

888-426-4435

Free access to website

$110.00 fee for hotline service

*90% of the fee is covered with ASPCA insurance

 

• Pet Poison Helpline

http://www.petpoisonhelpline.com

855-746-7661

Free access to the website. $89.00 fee for hotline service

 

General Recommendations for Compounding

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA permits compounding of animal drugs when the source of the active ingredient is a finished FDA-approved drug, and not a bulk drug substance (BDS), unless certain exceptions, described below, are followed. A “bulk drug substance” is a substance used to make a drug that becomes an active ingredient in the drug’s finished dosage form.³⁴ Most pharmacists would recognize that as an active pharmaceutical ingredient (API).

A commercially available drug may not always be available or appropriate for veterinary use. For example, an FDA-approved drug may contain excipients or preservatives that are unsuitable for a particular species, the available strength may be inappropriate, or the dosage form or flavor may make administration difficult. When no medically appropriate FDA-approved, conditionally approved, or indexed drug can be used, and an FDA-approved drug cannot appropriately serve as the source of the active ingredient, a drug compounded from a BDS may be medically necessary. In 2022, FDA issued Guidance for Industry (GFI) #256, Compounding Animal Drugs from Bulk Drug Substances, which describes circumstances in which FDA generally intends to exercise enforcement discretion for animal drugs compounded from BDS.³⁶ FDA maintains lists of BDS that may be used under specified circumstances for office stock for nonfood-producing animals and for certain preparations for food-producing animals or free-ranging wildlife. These substances are not FDA-approved drugs; rather, their use may fall within FDA’s enforcement discretion policy when the conditions described in GFI #256 are met.³⁶ Compounders must also meet applicable documentation, sourcing, labeling, and adverse-event reporting requirements described in the guidance.

In August 2026, FDA issued draft GFI #256B, Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities. The draft guidance proposes an enforcement policy for animal drugs compounded from BDS in FDA-registered facilities operating in accordance with current good manufacturing practice (cGMP). It does not apply to ordinary state-licensed pharmacies that are not federally registered or to drugs compounded from FDA-approved animal or human drugs. If finalized, GFI #256B is expected to be combined with GFI #256. Because GFI #256B remains a draft guidance and is not yet for implementation, compounders should monitor FDA updates before changing practice based on its recommendations.

The FDA has composed a checklist for pharmacists regarding veterinary compounding.³⁵

1. Confirm whether patient(s) is a nonfood-producing animal or a food-producing animal. Make sure that chicken is just a pet! Food-production animals (cattle, chickens, etc.) have an additional set of rules (not discussed here). Check the FDA guidelines for more information.³³
2. Follow all state laws and regulations that apply to compounding animal drugs. Compounders need to check their state regulations. It appears that most states tend to merely restate FDA animal compounding guidance.
3. Meet USP standards and FD&C Act requirements. Use FDA-approved drugs or FDA-approved BDS, follow USP guidelines and monographs, if they exist, and follow FD&C Act requirements.
4. Include all labeling information. See below.
5. Dispense the compounded drug(s) to the patient’s owner or caretaker or the veterinarian who prescribed or ordered it. A valid veterinarian-client relationship must exist, and a veterinarian must provide a valid prescription.
6. Report adverse events and product defects associated with the compounded drug to the FDA on Form FDA 1932a.
7. Consider other FDA-approved options first. Check to see if alternative options are available. Compounding is permitted if the active ingredient is a different salt, ester, or other derivative.
8. Determine if you are compounding a copy of an FDA-approved product. If the exact form of medication is commercially available, it cannot be compounded.
9. Obtain a medical rationale and retain it in your records if a copy is needed. The rationale for the compound must be documented on the prescription.

Other considerations include determining the physical and chemical compatibility of the drugs, the drugs’ solubility and stability, and the active ingredients’ pharmacodynamics.

Labeling

In addition to including the client's name on the label, the American Veterinary Medical Association (AVMA) recommends veterinarians and compounders in veterinary offices convey the following information to animal owners when prescribing all compounded preparations^38,39:

• Name, address, and telephone number of veterinarian
• Identification of animal(s) treated, species, and number of animals treated, when possible
• Date of treatment, prescribing, or dispensing of drug
• Name, active ingredient, and quantity of the drug (or drug preparation) to be prescribed or dispensed
• Drug strength (if more than one strength available)
• Dosage and duration
• Route of administration
• Number of refills
• Cautionary statements, as needed
• Beyond-use date (BUD)
• Slaughter withdrawal and/or milk withholding times, if applicable

Per FDA regulations, pharmacies must include the following on the compounded drug’s labeling: name and strength or concentration of drug; species and name or identifier of patient(s); name, address, and contact information for the compounding pharmacy and name of the prescribing veterinarian; a beyond use date; the withdrawal time as determined by the prescribing veterinarian; and the following statements must be included³⁴:

• “Report suspected adverse reactions to the pharmacist who compounded the drug and to FDA using online Form FDA 1932a.”
• “This is a compounded drug. Not an FDA-approved or -indexed drug.”
• “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

 

CONCLUSION

On June 10, 2021, the FDA finalized Guidance for Industry (GFI) #263, (not to be confused with GFI #256 which was mentioned previously) requesting that participating animal drug companies voluntarily transition certain antimicrobials from over-the-counter availability to veterinary prescription within two years. The aim of this guidance is to decrease antibiotic resistance in animals, and the target date to introduce new prescription labels onto the market was June 11, 2023.³⁹ These include well-known antibiotics such as erythromycin, gentamicin, penicillin, sulfamethoxazole, and tetracycline. This FDA requirement is now in effect for food-production animals and pets, and it may be one reason why many pharmacies have seen an increase in pet prescriptions. Another reason may be that more pet owners trust their local pharmacy to prepare the correct formula for their furry family members.

The field of veterinary medicine is expanding seemingly daily, and it is a field where compounding pharmacies can be instrumental. Veterinary compounding has its challenges, but when collaborating with a veterinarian, the compounder can impart professional judgment to ensure that the compound is safe, effective, and therapeutic. That’s a rewarding practice in the end.

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INTRODUCTION

 

Nora is an 8-year-old with refractory epilepsy. Her seizures have improved since she started a medically supervised ketogenic diet. Her neurologist prescribes valproic acid oral solution as adjunctive therapy, and her mother brings the prescription to the community pharmacy. At intake, pharmacist Elena Ruiz records that Nora cannot yet swallow pills. She reviews Nora’s prescription before dispensing it, but she finds that commercial pediatric valproic acid oral solutions contain sorbitol, sucrose, and glycerin. Because Nora’s ketogenic diet requires careful tracking of all carbohydrate sources, Elena contacts Nora’s neurologist to share her concerns.

 

BACKGROUND

 

Pharmaceutical compounding is the art of mixing and manipulating ingredients to create customized pharmaceutical formulations tailored to individual patient needs.¹ The United States Pharmacopeia (USP) defines compounding as “the preparation, mixing, assembling, altering, packaging, and labeling of a drug … in accordance with a licensed practitioner’s prescription.”² Patients require compounded medications when commercially available medications are inappropriate for safe and effective use or when the required medication is unavailable due to drug shortages. In these cases, compounding becomes essential to fill treatment gaps.

 

Many commercially available medicinal products are unapproved for pediatric use, as they are primarily tested in adult populations due to safety concerns, ethical barriers, and financial constraints.³ Consequently, many medications are unavailable in child-friendly dosage forms, flavors, or strengths. These treatment gaps in pediatric care prompted the European Medicines Agency, the United States Food and Drug Administration (FDA), and the World Health Organization to launch campaigns and research projects to develop pediatric-specific medications.^3,4 The International Council for Harmonisation (ICH) developed the E11 guideline on pediatric clinical investigation in 2000.⁵ The European Union, the FDA, and government bodies in countries such as Canada, Australia, Switzerland, and Japan have implemented legal provisions to support the development of dosage forms appropriate for children for new drugs.⁶

 

Despite these global efforts, children still lack access to commercial products suitable for their developmental and disease statuses.⁴ Clinicians frequently prescribe commercial medications off-label for pediatric use, and about 40% to 50% of medications administered to hospitalized pediatric patients in the United States are unapproved for children.^4,7 Caregivers often modify these medications to better suit pediatric use because the available dosage forms and strengths are unsuitable for children.^4,7 A Norwegian study found that 17% of oral medications in hospital settings, especially tablets, were manipulated for pediatric administration.⁸

 

Pediatric patients differ from adults in their ability to use various dosage forms and in their pharmacodynamics and pharmacokinetics.⁹ Using adult-studied drugs in children is challenging due to fundamental differences in metabolism and organ maturity, and inappropriate drug manipulation by untrained personnel can lead to severe adverse events.¹⁰ For example, splitting and crushing pills for pediatric use results in medication loss and incomplete dosing.⁸ A United Kingdom case involved a young patient with a malignant brain tumor who, during a prochlorperazine mesylate oral liquid shortage, received crushed prochlorperazine maleate tablets. The patient subsequently experienced uncontrolled vomiting and hospitalization due to inadequate dosing caused by the tablet’s low solubility.⁴

 

Safe and effective compounding practices are essential for the pediatric population. Compounding pharmacists and pharmacy technicians must have in-depth knowledge of drug properties and carefully evaluate each patient's condition to formulate appropriate treatment options. By doing so, they address therapeutic gaps left by commercial products, thereby protecting pediatric health and improving treatment outcomes.

 

Reasons for Extemporaneous Compounding in Pediatric Care

 

Difficulty Swallowing Commercial Solid Dosage Forms

 

Approximately 70% of commercially available medications are tablets.¹¹ Pharmaceutical companies prefer tablets and capsules for their shelf stability, flexible manufacturing, and cost-effective production.¹² While tablets and capsules are common and convenient for most adults, they are often unsuitable for pediatric administration. In a survey completed by 304 parents or caregivers, more than half reported difficulty swallowing standard-sized tablets or capsules, and respondents did not support pill-swallowing training.¹³ A Swedish study applied in situ coating to placebo capsules to improve swallowing in 78 pediatric patients, but 14 still had difficulty despite the intervention.¹⁴ Another study assessed 6- to 11-year-olds for swallowing ability and tried to teach them to swallow pills, but 9% could not learn.¹⁵

 

Difficulties swallowing solid dosage forms, especially tablets and capsules, are the main reason for compounding in pediatric care.⁸ This struggle is due to developmental immaturity or emotional and psychological factors causing fear and anxiety about solid medications.¹⁶ Some patients require enteral feeding tubes, further limiting the use of pills.⁹ Children with sensory disorders like autism or feeding disorders such as dysphagia also have trouble swallowing pills.¹⁷ Pill-swallowing difficulties can lead to nonadherence and reduced treatment effectiveness.¹⁶ Caregivers may manipulate medications (e.g., crushing or splitting tablets) without consulting a health care professional, increasing the risk of medication errors and adverse events.¹⁶ Compounding pharmacists formulate alternative dosage forms for children to address these challenges. Figure 1 illustrates commonly compounded alternative nonsterile dosage forms available for pediatric patients.

 

Figure 1. Compounded Nonsterile Dosage Forms for Pediatric Population

In a global pediatric compounding survey, more than 90% of respondents prepared oral liquids, making them the most commonly compounded oral dosage form for children.¹⁸ Prescribers and caregivers prefer oral liquids for children because they enable easier administration and precise, titratable dosing. A variety of other oral dosage forms are compoundable and suitable for specific medications or particular patient needs. These include lozenges and troches, rapid-dissolve tablets (RDTs), and more child-friendly options such as lollipops and gummies. Lozenges and troches, and lollipops, are held in the mouth to achieve local or systemic effects.¹¹ Rapid-dissolve tablets disintegrate quickly in the mouth, offering an alternative for patients who have difficulty swallowing.³

 

If oral administration is clinically impractical or undesirable, practitioners may also prescribe compounded non-oral dosage forms for local or systemic delivery. These include topical formulations such as creams and ointments. Other compounded dosage forms include suppositories for rectal administration and enemas for colonic delivery. Rectal dosage forms are useful for children who vomit as a result of an illness, because they are at risk of losing doses when they vomit.⁹

 

Allergies or Intolerances to Inactive Ingredients

 

Commercially available medications contain various excipients that act as diluents, binders, stabilizers, fillers, buffers, preservatives, and more.¹⁹ Many children have allergies or intolerances to certain excipients, necessitating customized formulations that exclude these ingredients. Some patients have dietary restrictions that limit certain ingredients.

 

Some patients may require compounded medications because of the following allergies, metabolic disorders, or dietary restrictions^20,21:

• Children with corn allergies must avoid formulations containing high-fructose corn syrup and sorbitol, requiring a compounded formulation with a solvent free of those substances.
• Patients with severe milk protein allergy should avoid medications containing lactose due to the risk of developing hypersensitivity reactions.
• Sorbitol, a sweetener commonly added to pediatric oral formulations to improve palatability, is metabolized to fructose. A child with fructose intolerance cannot take commercial medications containing sorbitol.
• Vegan patients who cannot ingest any animal byproducts cannot take many commercially available capsules that contain bovine- or porcine-derived gelatin.

 

Nora’s ketogenic diet is high in fat but strictly limits carbohydrate and protein intake.²² It induces ketosis, in which the body primarily uses ketone bodies derived from fats as an energy source.²² The mechanism by which ketosis controls seizures is unknown, but it is an effective nonpharmacological treatment for refractory seizures in children.²² Nora should avoid the commercial valproic acid liquid because its carbohydrate content from sucrose, sorbitol, and glycerin could compromise her ketosis.²³ She also cannot use commercial valproic acid capsules because her exact dose is unavailable in pill form and she cannot swallow standard-size pills. Elena concludes that a sucrose-, sorbitol-, and glycerin-free valproic acid liquid best meets Nora’s needs and is not "essentially a copy” of a commercial drug under the FDA guidance.²⁴ With Elena’s recommendation, Nora’s neurologist determines that making Nora’s medication swallowable and carbohydrate-free will make a significant clinical difference for Nora, documents the change, and updates the prescription accordingly.

 

Inappropriate Commercial Strengths for Pediatric Patients

 

Pediatric dosing requires precise calculations that account for the patient’s age and developmental factors. Clinicians calculate pediatric doses based on body weight (mg/kg) or body surface area (mg/m²). Because the resulting doses are highly patient-specific, using standard adult strengths safely in children is challenging. Caregivers of infants under the age of two often face issues with inappropriate (often too large) medication strengths.⁸ For children who can swallow pills, caregivers may cut them to reduce the dose strength, but many are enteric-coated or extended-release. A child’s dose requirement throughout childhood and adolescence can vary by up to 100-fold, requiring a wide range of strengths.⁹ Compounding medications into liquid dosage forms like solutions and suspensions in varying concentrations allows pediatric patients to safely receive their precise dose.

 

Importance of Oral Liquid Concentration Standardization

 

Concentrations of the same active ingredient in liquid form can vary across products from different pharmacies, increasing the risk of medication errors. Even within an organization, compounded oral liquids’ final concentrations can vary significantly, leading to dosing errors.²⁵ For example, a mother accustomed to giving 5 mL of a 25 mg/mL medication might not realize that another pharmacy compounded a different concentration. If she gives the child 5 mL of a 50 mg/mL preparation of the same medication, the patient receives a double dose. This is especially dangerous in pediatric patients, who are more vulnerable to dosing errors than adults.

 

To reduce such errors, several organizations have standardized the concentrations of common children’s liquid medications. The University of Michigan Health System (UMHS), with the Michigan Pharmacists Association (MPA), surveyed 244 Michigan pharmacists. They found that of the 146 medications surveyed, more than half were compounded in three to nine different concentrations by different pharmacists across the state.²⁶ To reduce dosing errors resulting from varying concentrations, the UMHS pharmacists compiled a standardized concentration list for commonly compounded medications in 2014.²⁷ In 2016, the American Society of Health System Pharmacists (ASHP) and the FDA published a standardized oral liquid concentration list, as part of the Standardize 4 Safety (S4S) initiative.^17,28 S4S is the first national interprofessional effort to standardize medication concentrations to reduce errors, especially during care transitions.^25,29 The standardized concentration lists are important resources for compounding pharmacists to minimize dosing errors.

 

Upon receiving Nora's updated prescription, Elena realizes that she does not have a sugar-free Master Formulation Record (MFR) for valproic acid and searches her references for a proven and published formulation. After searching resources like the API manufacturer and reputable children’s hospital databases, she finds a validated MFR for a sugar-free valproic acid 100 mg/mL emulsion.³⁰ Since sugar-free does not necessarily mean ketogenic-friendly, Elena confirms with Nora’s dietician that the formula’s ingredients will not affect Nora’s ketogenic diet. Because its concentration is twice that of the commercially available 50 mg/mL liquid, Elena confirms the prescribed dose and corresponding dose volume with Nora’s neurologist. The SIDEBAR describes the steps Elena would take if she could not find a suitable formulation.

 

SIDEBAR: What if Elena could not find a verified MFR?

 

In many cases, compounding pharmacists find suitable pediatric compound formulations with appropriate beyond-use dates (BUDs) and stability data from credible formula databases that are readily available online. For example, Nationwide Children’s Hospital in Columbus, Ohio, and the Hospital for Sick Children in Toronto, Ontario, Canada, have comprehensive pediatric compounding formula indexes accessible to external healthcare providers.^31,32

 

If Elena cannot identify a suitable published formulation, she should first reconsider approved alternatives with the prescriber. If compounding remains necessary, the pharmacy may undertake formal formulation development only if it has the necessary expertise, facilities, quality systems, and access to appropriately designed stability testing. Otherwise, Elena should refer the prescription to a qualified compounding pharmacy. The steps may appear simple, but are time-consuming:

 

• Assess whether formulation development is scientifically and legally feasible. This includes the drug’s solubility, pH, chemical stability, vehicle compatibility, particle-size and dose-uniformity requirements, excipient safety, microbial risk, container compatibility, and ingredient eligibility under section 503A. Not every bulk substance may legally be used.³³
• Develop and document an MFR. A qualified pharmacist could design a formula using established pharmaceutical principles, calculations, and compatible ingredients. The pharmacy would prepare a small test batch and evaluate its appearance, pH, redispersibility, uniformity, and other relevant quality attributes.
• Use an appropriately conservative BUD—but understand what it means. USP <795> provides maximum BUD limits when a USP monograph or preparation-specific stability information is unavailable. Those limits address general risk; they do not prove that a newly invented formulation retains its potency, remains physically uniform, or is bioavailable. Known or suspected instability requires a shorter BUD.²
• Obtain testing when the clinical risk warrants it. A qualified laboratory could conduct a stability study using a stability-indicating assay and, when appropriate, antimicrobial-effectiveness testing. A new dosage form might also raise bioavailability questions that a potency assay alone cannot answer. Testing requires a properly designed study using appropriate analytical methods, time points, storage conditions, and multiple batches. Because testing is time-consuming and costly, it may be impractical for a pharmacy to pursue this option, especially when the patient needs the medication promptly.
• Decline or refer the prescription if adequate quality cannot be supported. That is the crucial endpoint. The pharmacist should tell the prescriber, “I can’t identify or develop a formulation with adequate evidence of stability, uniformity, and safety. We need to select another product or refer the patient to a pharmacy with the necessary formulation-development and testing capabilities.”

 

Shortage or Discontinuation of Commercial Pediatric Medications

 

Drug shortages are another reason for extemporaneous compounding in pediatrics. Manufacturers adjust pediatric formulations’ concentrations and ingredients to account for pediatric patients’ vulnerabilities.³⁴ When a pediatric formulation is unavailable with no safe alternatives, clinicians may delay or cancel important treatment plans, causing considerable stress for patients and their caregivers.³⁴ Children’s hospitals spend 51 hours per week managing shortages, compared with 36 hours per week in other hospitals.³⁴ This illustrates that drug shortages are particularly damaging to the pediatric population. In community settings, caregivers risk encountering substandard drug products from unregulated manufacturers and sellers.³⁵ Pediatric compounding by trained professionals mitigates harm from drug shortages by providing safe alternatives. The FDA Drug Shortage Database provides information on resolved, active, and anticipated drug shortages.³⁶ Pharmacists should consult the FDA’s Drug Shortage Database if they receive compounding requests for commercially available dosage forms and strengths.³⁶

 

PAUSE and PONDER: Extemporaneous pediatric compounding requires sound clinical justification. What are some key clinical challenges that necessitate compounding for pediatric patients? How can pharmacy staff help identify the need for compounded preparations?

 

DOSAGE FORMS FOR PEDIATRIC POPULATIONS AND SAFETY CONCERNS

 

Throughout childhood, children’s bodies undergo constant growth and change.⁹ They may require varying dosages as their bodies and disease statuses change, but they may also need different dosage forms at various developmental stages.⁹ Pediatric patients, defined as children from birth to 18 years of age, are further classified into age groups based on their physical and psychological development.⁶ This classification helps inform many treatment decisions, including the appropriate dosage form selection. Table 1 presents the ICH pediatric population age classification.

 

Table 1. International Harmonisation Pediatric Age Classification^9,37

Classification	Age in completed days, months, or years
Preterm newborn infants*	N/A
Term newborn infants*	0 to 27 days
Infants and Toddlers	1 month to 23 months
Children†	2 to 11 years
Adolescents	12 to 16 or 18 years

^*Collectively called “neonates”

^†May be subdivided into pre-school (2 to 5 years) and school-age (6 to 11 years) based on their ability to use different dosage forms.

 

Within the pediatric population, the ability to use different dosage forms varies widely due to physical differences and developmental stages.⁹ Neonates, or newborns, and infants are physically immature and fully dependent on caregivers for feeding, which influences dosage form selection for this age group.⁹ For older children, tolerance and preferences strongly influence dosage form selection.

 

Since choking incidents peak between 9 and 24 months, solid or semi-solid oral dosage forms like lozenges, troches, or gummies are not recommended for children younger than 2 years old.³⁸ Chewable dosage forms like gummies improve palatability and ease of swallowing for patients 2 years or older depending on their developmental readiness and parental supervision, but children may mistake them for candy, leading to unintentional ingestion.⁹ Rapid-dissolve tablets have a low asphyxiation risk in pediatric patients, but they are technically challenging to produce in community settings (bitter APIs are difficult to mask in RDTs).^3,12

 

Liquid formulations are ideal for younger patients (i.e., birth to early school age) who cannot swallow solid dosage forms depending on the patient’s development, dose, drug properties, measurement accuracy, and caregiver capability.⁹ Caregivers prefer liquid formulations for younger children because of flexible dosing and easier swallowing, despite their storage and stability limitations.³ Oral liquid drops contain medication in minuscule volumes of liquid, making them suitable for medication delivery to neonates (but their high concentration can contribute to measurement errors).³⁹ Figure 2 lists the most common APIs compounded into liquid formulations for the pediatric population.

 

Figure 2. Common APIs Compounded in Liquid Form for Varying Pediatric Populations⁴⁰

 

Compounding pharmacists often prioritize using water-based or aqueous solvents when formulating oral liquids.⁴¹ Some APIs are more stable in oily bases, but oil suspensions pose a higher aspiration risk than aqueous suspensions in the pediatric population and may cause lipid pneumonia.⁴² When formulating liquid dosage forms for children, the compounding pharmacist must ensure that the concentration allows a dose volume that is neither too large nor too small.⁹ If the concentration is too high, measuring the required volume accurately is difficult, causing dosing errors. Conversely, if the medication is too dilute, the dose volume may be too large for the child to ingest comfortably, leading to poor adherence.⁹ For bitter APIs, compounding pharmacists support treatment adherence by optimizing the concentration to minimize dose volume. Typical tolerable dose volumes are up to 5 mL for children under 5 years old and up to 10 mL for older children.⁹ Suspensions allow higher drug loading than solutions, making them particularly useful for patients requiring a higher amount of drug per dose.⁹

 

In recent years, researchers have developed smaller tablets, or minitablets, as an alternative dosage form. Minitablets are a suitable alternative for pediatric patients who cannot swallow traditional pills or liquids.³ Children as young as 6 months old can swallow a single minitablet, but they are limited to extremely small doses.³ They may also be technically challenging to produce outside mass-production settings.

 

Compounders may prepare rectal suppositories in various sizes, and the appropriate size depends on the child’s age and size. For example, a typical suppository weight for infants is 1 g, which is half that of adult suppositories.⁹ Compounding pharmacists should also formulate each suppository as a single dose, and caregivers should administer them whole without cutting them.⁹ Prescribers need to exercise caution when choosing suppositories for young children, since premature expulsion from the administration site might lead to dose loss.⁹ Similarly, compounders should prepare liquid rectal enemas in single-dose volumes suitable for the child’s size. Typically, 1 to 5 mL per dose, depending on the patient’s age and size, is appropriate for enemas.⁹

 

Pediatric formulations contain sweeteners and flavoring agents to improve palatability and ensure patient acceptability. If stability data are unavailable for an aqueous preparation, the compounder may find a validated nonaqueous formulation or obtain stability data for the API in a nonaqueous vehicle. If compatible with the API, an oil-based vehicle may be more appropriate than an aqueous one for a formulation intended for long-term therapy due to its microbiological stability.^41,43 Fixed oils, or non-volatile oils, such as almond, peanut, sesame, olive, and corn oil, are useful in compounding APIs that are highly susceptible to hydrolysis.⁴⁴ Oil-based vehicles can also help mask bitter tastes of APIs by providing a coating over the taste buds.⁴⁴ Compounders must exercise caution when selecting a fixed oil vehicle because almond, peanut, and sesame are common allergens in pediatric patients.

 

From Yucky to Yum: Improving the Medication Palatability

 

Palatability is an important factor in determining whether a child will take the medication. Flavor, smell, and texture are important palatability characteristics that may dictate treatment success.⁹ Pediatric patients strongly dislike bitter medications and even some flavors used to mask their bitterness. Taste aversion leads to skipped doses and, in turn, treatment failure.⁹ In 2025, the University of Maryland School of Pharmacy published an evidence-based guide to poor-tasting pediatric liquid medications, called the Ew Meds List.⁴⁵ The list identified prednisone, penicillin VK, metronidazole, clindamycin, clarithromycin, and many others as the worst-tasting medications for children.⁴⁵

 

Different API forms, such as salts, esters, or prodrugs, can vary in bitterness, and compounders can use the milder-tasting salt forms to mitigate bitterness, if available. For example, metronidazole base is extremely bitter and metallic, so compounders use its ester form, metronidazole benzoate, for pediatric suspensions because it is virtually tasteless.⁴⁶ When switching the API form in a formulation, the compounding pharmacist needs to perform conversion calculations to ensure consistent dosing.

 

Compounding pharmacists often add flavors and sweeteners to pediatric formulations to improve the palatability of bitter medications. Compounders should discuss flavor preferences with the caregiver because age, gender, and sociocultural factors can strongly influence them. Certain flavors are particularly effective at masking specific unpleasant tastes, and Table 2 outlines the basic API taste categories and different flavors that help mask them.

 

Table 2. The Unpleasant Tastes of APIs and the Flavors to Mask Them^9,44,45

Taste	Flavor(s) used to mask
Bitterness ·       associated with high-molecular weight drugs, or polyhydroxyl (containing many -OH groups) compounds ·       e.g., caffeine, quinine sulfate, promethazine chloride, basic amino acids, codeine, etc.	In 1-3% concentration ·       Chocolate ·       Cherry ·       Spearmint ·       Crème de menthe ·       Marshmallow ·       Caramel ·       Banana Crème ·       Orange ·       Tangerine   Plus sodium chloride (table salt) in 0.5-1% concentration for extremely bitter APIs*
Saltiness ·       associated with inorganic compounds, low-molecular weight drugs, or presence of ions	Fruit flavors in 1-4% concentration ·       Strawberry ·       Raspberry ·       Orange ·       Cherry ·       Watermelon ·       Grapefruit ·       Lemon   Other flavors in 1-4% concentration ·       Butterscotch ·       Maple ·       marshmallow   Plus sweetener
Sourness/acidic ·       associated with acidic drugs	In 1-4% concentration ·       Raspberry ·       Cherry ·       Tangerine ·       Orange ·       Pineapple ·       Mango ·       Lemon ·       Strawberry   Plus sweetness using syrup or syrup vehicle

^*Adding 0.5% to 1% sodium chloride to a flavored preparation can help mask extreme bitterness.^47-49

 

Studies show that children strongly prefer sweet, fruit-flavored medications to those flavored with mint. For example, in a taste study of 110 children ages 5 to 11 comparing strawberry-flavored lansoprazole with peppermint-flavored ranitidine syrup, 95% preferred the strawberry formulation.⁵⁰ In a similar study of children ages 6 to 11, more than 92% preferred strawberry-flavored lansoprazole to peppermint-flavored ranitidine.⁵¹

 

Compounders sometimes combine marshmallow, caramel, or vanilla with other flavors to mask bitter APIs because their mild creaminess and lingering scent enhance and complement the added pleasant flavors.⁴⁴ Compounders may also use bitter-blockers to improve the taste of strongly unpleasant medications and reduce aversive aftertastes.^52,53 Bitter-blockers are compounds that interfere with the molecular pathways responsible for sensing bitterness. Examples include sodium salts, adenosine 5′-monophosphate, and lipoprotein and phospholipid complexes.^52,53 They may mitigate either the initial bitterness or the lingering aftertaste, or both.^52,53 While bitter-blockers offer a solution for bitter medications, they may pose safety risks to developing bodies and require age-appropriate toxicological evaluation, as with other additives.^52,53

 

“A Spoonful of Sugar Helps the Medicine Go Down”

 

Children exhibit a stronger aversion to the unpleasant taste of medicine and prefer a higher level of sweetness than adults.⁹ Consequently, sweeteners are commonly incorporated into pediatric oral preparations to improve acceptability. The sweeteners include, but are not limited to, sucrose, fructose, sorbitol, xylitol, mannitol, aspartame, sucralose, stevia, and acesulfame potassium.^9,21,44 Sucrose, or table sugar, is the most common sweetener in pediatric preparations. Compounders should use sucrose only in short-term therapies to prevent dental issues in children. Sucrose is unsuitable for children with fructose intolerance and patients with diabetes because sucrose metabolizes into fructose and glucose.⁹ Monosaccharide-derived sugar alcohols such as sorbitol, mannitol, and xylitol are safer for patients with diabetes because of their incomplete intestinal absorption.⁵⁴ Compounders should use them cautiously because they can cause osmotic diarrhea in high concentrations.⁹ Similar to sucrose, children with fructose intolerance cannot tolerate sorbitol, as it is also metabolized into fructose.⁹ Aspartame, an artificial sweetener 180 to 200 times sweeter than sucrose, is useful in preparations for patients who cannot tolerate natural sugars.⁵⁵ Patients with phenylketonuria should avoid aspartame because its molecular structure contains phenylalanine, which they cannot metabolize.⁵⁵ Compounders should use artificial sweeteners such as saccharin or aspartame at low concentrations because they can produce a bitter aftertaste at high concentrations.⁹ As a general rule of thumb, compounders should avoid using sweeteners at high concentrations for long-term use.⁹

 

PAUSE and PONDER: What are the key considerations for determining appropriate dosage forms for different pediatric subpopulations? How can pharmacists collaborate with prescribers to select the safest and most effective dosage form?

 

EXCIPIENT USE IN PEDIATRIC COMPOUNDING AND POTENTIAL RISKS

 

In pediatric compounding, compounding pharmacists strategically add excipients to formulations to improve the solubility, palatability, and stability of the API.⁵⁵ The non-medicinal components ensure that the compounded medications are palatable and easy to administer to young patients.²¹ Ideally, excipients should be pharmacologically inactive, but studies report adverse events linked to certain excipients, highlighting their potential toxicity in pediatric populations. Neonates are particularly susceptible to excipient toxicity due to immature renal and hepatic function, underdeveloped metabolic pathways, and a less robust blood-brain barrier.⁵⁵ Children absorb, distribute, metabolize, and eliminate APIs and excipients differently than adults, with substantial variability across age groups.⁵⁵ Numerous excipients that are harmless in adults may cause severe adverse events in pediatric patients when used without proper precautions.^21,41,55,56

 

In 2020, the Pediatric Pharmacy Association (PPA)’s 12-pharmacist panel analyzed literature and databases and compiled a Key Potentially Inappropriate Drugs for Pediatrics (KIDs List).⁷ The latest KIDs List, published in 2025, includes 10 excipients presented in Table 3 (derived from Table 2 of the 2025 KIDs List Report).⁷

 

Table 3. The KIDs List of Excipients with Known/Potential Harms in Pediatric Patients⁷

Excipients*	Major toxic effects	Recommendation	Recommendation Strength	Quality of Evidence
Benzyl Alcohol, sodium benzoate, benzoic acid	Gasping syndrome	Avoid exposure of >99 mg/kg/day in < 1 mo	Strong	High
Ethanol/ethyl alcohol (excluding ethanol lock)	CNS depression, hypoglycemia	Caution in < 6 yr: max 0.5% v/v ethanol with clinician supervision   Caution in <12 yr: max 5% v/v ethanol with clinician supervision	Strong	Moderate
Isopropyl alcohol (topical)	Chemical burn	Caution in patients weighing < 1500 g	Weak	Low
Methylparaben, propylparaben	Kernicterus	Caution in < 2 mo	Weak	Very Low
Phenylalanine	Cognitive and behavioral problems	Avoid in patients 18 years or younger with an unknown phenylketonuria test	Strong	High
Polysorbate 80	Vasculopathic hepatotoxicity (E-Ferol syndrome)	Avoid exposure of ≥ 72 mg/kg/day in < 1 mo   Caution exposure of > 1.4 mg/day in < 1 mo	Strong	High
Propylene glycol	Lactic acidosis, CNS depression, hypoglycemia, hemolysis, seizure	Avoid > 1 mg/kg/day in < 1 mo   Avoid > 50 mg/kg/day 1 mo to 5 yr	Strong	Moderate

^*Reviewed systemically absorbed excipients except for Isopropyl alcohol

 

Although color additives or dyes are not necessary excipients, compounders can add a color additive to match the medication's flavor if the patient or caregiver prefers a particular color. Hypersensitivity reactions to color additives are rare, but compounders should review documented allergies or previous reactions when selecting color excipients, as with other excipients.⁵⁷ Many formulations need excipients for stability, uniformity, or administration; compounders should use only those necessary and appropriate for the individual child.^9,21,55,56

 

Compounders looking for more information on pediatric safety on specific excipients may refer to the Safety and Toxicity of Excipients for Paediatrics (STEP) Database.⁵⁸ It compiles safety and toxicity data on more than 75 excipients used in pediatric formulations.⁵⁸ It is free but requires registration before access.

 

Before approving the formulation for Nora, Elena reviews each excipient and confirms its acceptability with Nora’s ketogenic-diet team. “Sugar-free” alone does not establish that a preparation is appropriate for a ketogenic diet.

 

PAUSE and PONDER: Which specific excipients pose severe toxicity risks for neonates and young infants? What safety checks can pharmacists and pharmacy technicians use to flag high-risk excipients before compounding a preparation?

 

BEYOND-USE DATING IN NONSTERILE COMPOUNDING: THE ROLE OF USP GENERAL CHAPTER <795>

 

Unlike drugs manufactured in outsourcing facilities under FDA section 503B, individually compounded medications prepared in accordance with FDA section 503A are generally not subject to routine FDA oversight.⁵⁹ This does not imply that quality standards are unimportant. Instead, state pharmacy boards oversee the state-licensed compounding pharmacies’ quality and safety standards.⁶⁰ Pharmacists rely on USP guidelines to ensure quality because compounded medications lack large-scale studies on safety, efficacy, and stability. The United States Pharmacopeia (USP) is an independent nonprofit organization that develops standards and guidelines for dietary supplements, food ingredients, and pharmaceuticals.² As part of this role, it develops Compounded Preparation Monographs, which provide tested formulations and compounding procedures.⁶¹ USP General Chapter <795> outlines nonsterile compounding guidelines and standards that state boards may or may not enforce.² It sets specific requirements for the management, testing, and storage of nonsterile compounded medications to uphold quality and patient safety.² Individual compounders must ensure that the end product meets the standards outlined in USP Chapter <795>.

 

Beyond-use dating (BUD) is important for ensuring the safe use of compounded preparations. It refers to the “date after which a compounded preparation shall not be used.”² The compounder calculates BUDs conservatively based on the following parameters²:

• API and excipients’ chemical and physical stability
• Container closure system’s compatibility with the finished preparation
• Container closure system’s degradation that can lead to the preparation’s integrity
• Potential for microbial growth in preparation
• Significant deviations from essential compounding steps and procedures that may impact the formulation’s stability

 

USP Chapter <795> defines aqueous and nonaqueous dosage forms based on their water activity ( _w). Water activity measures the unbound water molecules in a preparation that are available to support microbial growth.² The water activity of pure water is 1. Nonaqueous dosage forms have water activity less than 0.6, and aqueous dosage forms have water activity 0.6 or greater. Table 4 presents water activity for some common dosage forms in pediatric care. Because compounders typically do not measure water activity, the example data in Table 4 can assist with BUD calculation by dosage form.

 

Table 4. Water Activity ( _w) of Common Compounded Nonsterile Dosage Forms in Pediatric Care²

Nonaqueous ( w < 0.6)			Aqueous ( w ≥ 0.6)
Dosage Form	Description	w	Dosage Form	Description	w
Oil based oral solution	Medium chain triglycerides oil	0.338	Water based oral solution	Low-sucrose syrup vehicle	0.906
	Fixed oil with thickener	0.403		90% Water and 10% glycerin	0.958
Troche or lozenge	Gelatin base with £ 3% aqueous flavor	0.332	Water based suspension	Oral suspension base	0.992
	Polyethylene glycol base with £ 3% aqueous flavor	0.571	Simple syrup	Simple syrup	0.831
Lollipop	Sorbitol based	0.460	Cream	Cream vehicle (petrolatum free oil in water emulsion)	0.968
Suppository	Polyethylene glycol base	0.374	Gel	Alcohol-free aqueous gel	0.990

 

When a compounder uses a commercially available product as the API source, the commercial product’s expiration date alone does not determine the compound’s BUD.² The compounder should consult the API manufacturer’s stability information when available.² Additionally, compounding pharmacists should review the literature to gather information on API stability, compatibility, and degradation, and interpret the findings in the context of the compound.² In the absence of the API’s stability, compatibility, and degradation data, the recommended BUD limits for nonsterile compounds are outlined in Table 5. USP Chapter <795> recommends adding suitable antimicrobial agents to compounds with water activity greater than 0.6 to prevent microbial growth.² Pediatric formulations that cannot contain antimicrobial preservatives should be refrigerated as long as refrigeration is physically and chemically compatible.² If any ingredients’ expiration date is before the longest recommended BUD limit, then the preparation’s BUD is the earliest expiration date.

 

Table 5. BUD Limit in the Absence of Stability Information²

Water Activity	Type of Preparation	BUD (days)	Storage Temperature
Aqueous ( w ≥ 0.6)	Nonpreserved	14	Refrigerator*
	Preserved	35	Controlled room temperature or refrigerator†
Nonaqueous ( w < 0.6)	Oral liquids	90	Controlled room temperature or refrigerator
	Others	180	Controlled room temperature or refrigerator

^{*2° to 8°C (36°F to 46°F)}

^†20° to 25°C (68°–77° F)

 

Importance of Documentation: Master Formulation Record (MFR) and Compounding Record

 

According to USP General Chapter <795>, compounding pharmacists must create an MFR for every new and unique formulation.² Master Formulation Records are detailed compounding recipes that all compounders must follow. They outline the compounding process step by step to ensure consistent final product quality and reduce variability in the medication’s efficacy and safety. An MFR needs the following information:²

• Name, strength, dosage form
• Name and amount of all ingredients and their relevant characteristics
• Container closure system
• Equipment, supplies, and complete compounding steps
• Physical description of the final compounded product
• Beyond-use Date (BUD) and storage requirements
• Reference source to support assigned BUD
• Specific labeling requirements
• Quality control procedures and expected results

 

Compounding Records (CRs) document each compounded batch preparation according to the applicable MFR.² Compounding pharmacists must generate, review, and date the CR before the pharmacy dispenses the compounded preparation to the patient.² CRs allow pharmacists to track the compounded batch’s details in the event of ingredient recalls or quality issues.² The compounding pharmacist should document the following information in the CR:²

• Name, strength, dosage form
• Date and time of compounding the preparation
• Assigned prescription/order/lot number
• Identification of personnel involved in compounding
• Name, manufacturer, lot number, and expiration date of each ingredient
• Weight/volume of each ingredient
• Total quantity of the compounded preparation
• Assigned BUD and storage requirements
• Physical description of the final product
• Quality control results
• MFR reference

 

Elena reviews the published formulation, stability data, ingredients, preparation method, storage conditions, and applicability to Nora. She uses that information to develop and have the designated person approve the pharmacy’s MFR and product labeling. After compounding Nora’s prescription, Elena completes the corresponding CR and assigns the preparation’s BUD and storage conditions according to the supporting stability data.

 

PAUSE and PONDER: Which compounded dosage forms fall under the nonaqueous ( _w < 0.6) category? Which compounded dosage forms fall under the aqueous ( _w ≥ 0.6) category?

 

PEDIATRIC COMPOUNDING RESOURCES

 

Compounding pharmacists and technicians need readily available resources. Before deciding to create a new formula for a patient, a compounding pharmacist should first consult credible references for existing MFRs. Many commonly prescribed pediatric compounds already have vetted, documented MFRs available online. Many of these published formulations have also undergone stability testing. Compounding pharmacists should review these resources before generating new formulations. Some are free online, while many others require a subscription fee.

 

• The United States Pharmacopeia Compounding Compendium is another resource that contains more than 170 compounding monographs.⁶¹
• Online electronic databases such as Micromedex and Lexicomp Online contain some monographs with compounding instructions.⁶²
• Compounding suppliers such as Medisca, Fagron, and Professional Compounding Centers of America (PCCA) have their own formulation databases, with some having extended BUDs established through in-house testing.^63-65
• Professional Compounding Centers of America (PCCA), which requires membership, is also an extensive network of compounding experts and resources, offering hands-on training, specialty symposia, seminars, and various continuing education opportunities.⁶⁵
• S. Pharmacist, a monthly trade publication for pharmacists that provides up-to-date, peer-reviewed clinical articles, also has a database of compounding formulas that are free to access online.⁶⁶
• Compounding Today, which is a subsidiary of the International Journal of Pharmaceutical Compounding, is an interactive website that has a variety of information, including formulations, comparisons of oral vehicles, and flavoring. Compounders should verify that information in this journal is peer-reviewed.⁶⁷
• Nationwide Children’s Hospital and the Hospital for Sick Children have comprehensive databases of pediatric compounding formulas freely accessible to external providers.^31,32
• For compounders who prefer hard copies:
  • The Art, Science, and Technology of Pharmaceutical Compounding covers all aspects of compounding, including regulatory, technological, scientific, and clinical consulting on dosage forms. It provides sample formulas for various dosage forms and addresses flavoring, sweetening, preservation, compliance, quality control, and potential errors.⁶⁸
  • Extemporaneous Formulations for Pediatric, Geriatric, and Special Needs Patients is a book of compounding “recipes” that contains 312 easy-to-follow formulations.⁶⁹

 

CONCLUSION

 

At pickup, Elena explains the new concentration and dose volume to Nora’s mother and asks her to demonstrate how she will measure the dose. By recognizing an unsuitable commercial formulation, collaborating with the prescriber, verifying an appropriate compound, and preventing a concentration-related dosing error, Elena helps Nora continue both her medication and ketogenic diet safely.

 

Pharmaceutical compounding optimizes therapeutic outcomes for pediatric patients. By addressing challenges such as difficulty administering medications, ingredient intolerances, and drug shortages, pediatric compounding provides safe treatment alternatives for optimal care. Compounding personnel should adhere to safe compounding practices by avoiding harmful excipients, selecting age-appropriate dosage forms and concentrations, and assigning correct BUDs. Such diligent safe practices, along with careful attention to individual preferences, reduce the risk of adverse events by ensuring quality compounded preparations, thereby supporting children’s well-being.

 

 

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INTRODUCTION

With the increased interest in specialized, veterinary, and cannabidiol (CBD) compounds, pharmacy staff who work in academia and specialize in compounding occasionally field questions from start-up companies that need help selecting the best equipment for their needs. Most compounders who have these questions are aware of compounding equipment’s advantages; the machines are semi-automatic or automatic, streamlined, safe, and more efficient and faster than humans.^1,2 Saving time means saving money! When used according to the directions, they also produce products with accurate dosing.^1,2

 

Pharmacy compounders who are considering the purchase of machines always have additional questions. They want to know if specific equipment will decrease human exposure to medications and decrease the likelihood of human error. They also ask if machines can decrease repetitive motions. What is the likelihood of cross contamination? And will the finished products be pharmaceutically elegant? Unfortunately, compounding experts will not have a one-size-fits-all answer. Each compounding lab will need to conduct a needs analysis before considering new equipment. Choosing compounding equipment without a needs analysis is how pharmacies end up with very expensive dust collectors.

 

CONSIDERATIONS FOR SELECTION

Before purchasing any machine, decision makers need to ask, “What specific problem does this solve, and how often will we have that problem?” The answer to that question must be data driven.

 

First, decision makers need to define the scope of services the pharmacy provides.³ It’s critical to choose equipment based on type of medications being compounded now (see Table 1), and to also consider how the business may grow in the next few years.  When looking at the compounded product types, the employee or employees doing the analysis need to augment the data with the volume or frequency that the pharmacy compounds each type of product.³ Things to think about include peak and average workload, batch compounding as opposed to one-off prescriptions, and the patient’s or customer’s typical turn-around expectations. The goal is to determine which compounds the staff makes often enough and in large enough quantities that automation would be a reasonable consideration.

 

Table 1. Types of Compounded Products
Nonsterile	Capsules Creams Gels Gummies Ointments Solutions Suspensions Troches
Sterile	Intravenous Ophthalmics
Hazardous drugs (e.g., oncology)

 

Second, decision makers need to look at the various formulations they compound and assess their complexity. They need to look at each formulation and determine if it requires some kind of special approach. It might be high shear mixing, precise particle size reduction, or homogeneity testing.  The high-shear mixing process involves using shear to emulsify, homogenize, disperse, or reduce particle size. This shear force occurs when part of the mixture is pushed in one direction, while the other part is pushed in the opposite direction simultaneously. If the shear force is higher, the particles mix more evenly due to the particle size reduction outcomes, which assists in homogenization.  An example of this would be creating a cream or lotion with an oil and water base.⁴ These compounds tend to be more complex than other compounds, and if they are produced in large enough batches, the decision makers may need to look at mixers, electronic mortars and pestles, or homogenizers. Concurrently, they need to look at each compound and ask, “What level of dosing accuracy is required?” If any of these products include drugs with narrow therapeutic indexes or are destined for pediatric or neonatal patients, it's possible that automated dispensing systems, precision balances, or capsule filling machines could be helpful.

 

Third, it's always important to look at regulatory and compliance considerations.⁵ People who make these decisions need to be fully educated about the United States (U.S.) Pharmacopeia chapters <795>, <797>, and <800>.^6-8 In addition, they need to be aware of their State Board of Pharmacy rules. This means that they should determine if any environmental monitoring, documentation systems, or closed system transfer devices are needed. (A closed system transfer device is a drug transfer system designed to prevent hazardous drugs from escaping into the environment and to block contaminants from entering the system during preparation and administration.) Any equipment that they purchase must be in compliance with the rules and not purchased just to improve production. This is also the time to also ask if the specific piece of equipment will provide traceable documentation. If batch-to-batch consistency is imperative, documentation is an indispensable element of the pharmacy’s quality assurance program. ^6-8

 

Fourth, space and facility constraints are very important.^3,5 Before purchasing any machine, pharmacy staff should look at their available square footage and cleanroom requirements to determine if the machine will even fit.⁵ A good way to do this is to determine the equipment’s size and construct a dummy out of cardboard. Placing it in the workflow will help determine if the machine will work for the specific pharmacy. Many machines are large and will require dedicated space or specific ventilation. A PRO TIP is to ask, “Does it integrate with your existing equipment?”⁵ Integration means that the new machine may need to be able to “talk” to the pharmacy’s software, labeling systems, and barcoding.⁵

 

Fifth, decision makers need to assess the pharmacy team's current skill levels and determine if the staff will need additional or extensive training.^3,5 If the team's skill level is only basic, or if the pharmacy experiences high employee turnover, it might be important to look for simpler equipment rather than fancier equipment. While conducting this part of the needs assessment, decision makers also need to determine if manufacturer support and training is available and included in the purchase price. If it is not included in the purchase price, the budgeting process will need to reflect the additional cost.

 

A related concern is how the physical work of compounding affects employees’ bodies over time, referred to as ergonomics. Many compounding tasks—grinding powders with a mortar and pestle, mixing thick creams by hand, filling capsules, drawing up liquids into syringes by the hundreds, and even keyboard strokes—are very repetitive.⁹ Small, precise motions repeated hundreds of times can be more damaging than heavy lifting—because they never give muscles a break.^10,11 Over time, drawing 0.5 mL 300 times is more straining than lifting a heavy box 10 times. Employees may develop wrist pain, hand fatigue, shoulder or neck strain, or long-term injuries that require workman’s compensation.^9,10 A PRO TIP is to replace the question, “Can an employee do this task?” with, “Can an employee do this task all day, every day, without risk of injury?” If a machine can save employees from strain or injury, it might be worth it—even if it doesn’t save much time.

 

PAUSE AND PONDER: A technician draws up small volumes (0.5–1 mL) into syringes for 2–3 hours straight. Why is this more tiring than it sounds? What small muscles are being overused? What could reduce strain without full automation?

 

Repetitive hand motions could cause carpal tunnel syndrome, which is caused by compression of the median nerve. This causes pain, numbness, and tingling in the hand.¹²

 

Sixth, developing a budget isn’t as simple as just determining how much money is available.³  Two questions should drive budgeting:

• “Will this machine pay for itself?”
• “What happens if it breaks?”

 

The answers to these questions emanate from an analysis of upfront costs and the long-term anticipated return on investment.³ Sometimes, decision makers overlook hidden costs like maintenance and calibration costs, consumables and proprietary supplies (supplies that are only available from the manufacturer), and service contracts.⁵

 

During the budgeting process, decision makers should delve into some additional concerns listed in Table 2.  A snazzy machine with poor vendor support becomes useless quickly.

 

Table 2. Vendor Support & Reliability5

Is technical support readily available? What is the typical or guaranteed response time? What is the process for machine cleaning and calibration? Does the vendor supply replacement parts or can they be purchased elsewhere? Does the vendor provide training? If so, is it free or associated with a charge? What happens if the machine fails? What is the backup plan or work-around process? What is the cost of the service contract and does it include replacement parts?

 

A final and seventh step is to ask, “What specific problem does this solve, and how often will we have that problem?”

 

SIDEBAR: Stop Calling It Personal Protective Equipment!^6-8

Experts now discourage the term “personal protective equipment” (PPE) in cleanroom settings because it implies protection of the worker, while the primary goal is protection of the product from contamination. Cleanroom standards (e.g., United States Pharmacopeia <797>) emphasize garbing to maintain aseptic conditions. Using “PPE” can lead to incorrect practices, such as prioritizing self-protection over sterility, potentially increasing the risk of microbial contamination in compounded sterile preparations.

And the USP documents themselves are confusing! USP <800> uses PPE but <795> and <797> used the preferred term “garb”!

So say it! In compounding we garb!

 

Heads = Machine, Tails = Employee

After completing the seven steps described above, it may be clear that the pharmacy has the volume, money, and justification to purchase a machine.³ However, it's a good idea to play devil's advocate and think about ways to reduce strain without full automation. This is a good brainstorming activity for the entire staff.

 

Some ways to reduce strain include rotating tasks every 30 to 60 minutes, so that staff members alternate fine motor tasks and non-fine motor tasks, and scheduling micro breaks.⁹ It's also possible to tweak equipment so that there's less strain on employees. Using larger syringes when possible uses less force per draw. Choosing low resistance syringes can decrease strain because they have smoother plunger actions. Employees can also use a syringe holder, or a stabilizing device and training should emphasize ensuring proper hand positioning.⁹

 

Regardless of the type of equipment being used, compounders should use disposable products when applicable (i.e. weigh boats [a small, shallow, disposable container used in laboratories to hold solids while they are being weighed on a balance], or single use oral syringes) in conjunction with their equipment. They increase infection prevention and patient safety by avoiding cross contamination; they save time and labor by not having to clean and sanitize in between compounds; and there is no maintenance involved. There may also be potential for bulk buying discounts.

 

Decision makers need to keep one more thing in mind when they select equipment. USP <795> requires compounding pharmacies to clean and maintain the equipment according to written procedures.⁸   The PRO TIP here is that as soon as equipment is purchased, the pharmacy needs to establish and follow such procedures.

 

Let's look at the types of available equipment.

 

EQUIPMENT TYPES AND PURPOSES

Weighing and measuring equipment in compounding ensures accurate quantities, which are critical for safety and effectiveness. This includes balances for weighing powders and volumetric measuring devices (e.g., graduated cylinders, syringes) for liquids. Selection depends on the required precision—small volumes or potent drugs demand higher accuracy. Employees must calibrate equipment and use it properly to avoid dosing errors. Inaccurate measurement can lead to subpotent or toxic preparations, making proper technique and maintenance essential in both sterile and nonsterile compounding.

 

Choosing the right scale depends on the pharmacy’s specific compounding needs. Most quality scales range from $500 to $2,000. Scales come in two types: analogue and digital.

 

The USP discusses and requires Class A prescription scales on compounding pharmacies.¹³ All state laws require a Class A scale or a scale that is more sensitive in licensed pharmacies, too. This level of mechanical balance is sensitive enough to detect small weight changes, with a sensitivity requirement of 6 mg or less and a minimum weighable quantity of 120 mg (to ensure error will be 5% or less). This means adding 6 mg will move the pointer one division on the scale. Because of this level of precision, Class A balances are considered appropriate for accurately weighing ingredients used in compounded preparations. A Class A balance is defined by how little weight it can detect (again, 6 mg or less)¹³; in case you are wondering, there are no official Class B or C balances in USP compounding—just balances that either meet the standard or don’t.

 

An analogue scale is a mechanical device that uses physical weights, springs, or balance beams and does not need electricity. It uses the principle of equilibrium, comparing the unknown weight with standard weights.¹⁴ Analogue scales are less costly than digital scales. All older pharmacies had torsion balances, which are a form of analogue scale, which did not require electricity. They were extremely durable and highly accurate when used correctly. In the “old days,” schools of pharmacy taught students how to use these scales. Many schools no longer teach this, considering these scales old-fashioned. Yet a survey that received 372 responses from pharmacies in Missouri found that almost half of those pharmacies (46.8%) owned a torsion balance.¹⁵ Almost 60% of pharmacists-in-charge recommended continuing to teach how to use torsion balances.¹⁵  Do you still have a torsion balance in your practice?

 

Over time, mechanical parts may loosen and analogue scales will need recalibration using certified weights. Ideally, a compounder should test the balance with a standard weight set before the scale is used each time and should arrange to have the scale calibrated professionally every one to two years, depending on its amount of use. In addition, parallax error—error that occurs when someone reads a scale or measurement from the wrong angle, rather than looking at it straight on—is possible. The compounder must look at the measurement mark at eye level. Because analogue scales are slow to use and require manual skill and calibration, human reading errors are possible, and today’s compounding pharmacies tend to use digital scales.¹⁴ (But having an analogue scale is handy if the power goes out or a digital scale breaks.)

 

Digital scales use electronic sensors to measure weight and display the result numerically.^16,17 Usually, these scales use a load cell to convert force (weight) into an electrical signal. A highly sensitive analog-to-digital converter changes the load cell’s electrical signal into a digital value. Next, a microcontroller is a calculator of sorts, changing the signal into an LCD display and telling the user what the item’s weight is. They are fast and easy to read, highly precise (often to milligrams or better), and sometimes include features like taring (resetting the scale to zero after placing a container on it, so employees only measure the substance they add—not the container), calibration alerts, and unit conversion. These features reduce human error. More costly than analogue scales, digital scales need a power source and can be sensitive to environment (vibration, airflow, static).^16,17 However, most new balances have a battery backup so they can still be used in case of a power outage.

 

When choosing scales, pharmacy staff should start by considering how precise their measurements must be (e.g., 1 mg vs. 1.001 g) and the typical quantity—small amounts or several kilograms. Space may matter, so a compact design can help. Many modern scales offer digital features like battery backup, USB, or Ethernet connectivity for data recording, and automatic internal calibration. Analog scales are more affordable and suitable for basic tasks, while digital scales provide greater precision and reliability, making them ideal for more demanding environments.^10,11,14,16

 

Other types of weighing scales include bench scales, truck scales, pallet scales, floor scales, and dynamic weighing systems.

 

Mixing and blending equipment ensures ingredients are evenly distributed so each dose is consistent and effective. This includes manual mortar and pestles, electronic mortar and pestles (EMPs), ointment slabs, electronic mixers, and homogenizers. The choice depends on the formulation—thick creams may require more force, while suspensions need uniform particle distribution. Proper mixing prevents “hot spots” (too much drug in one area), “cold spots” (areas with little to no drug), or separation.¹⁸ Equipment should be easy to clean and appropriate for the product to maintain quality and avoid contamination.

 

Using the traditional mortar and pestle, compounders crush and mix various ingredients to create a fine mixture by hand.¹⁹ They place the ingredients in the mortar (the sturdy bowl made of hard materials) and rub it with the pestle (the club-shaped implement used to pound or grind substances). The process can be time-consuming, and the final product may differ in consistency depending on who wields the mortar! Proper hand positioning in holding the pestle will reveal how skilled the compounder is.¹⁹

 

EMPs generally retail at about $2,000 to $4,000 each. They increase the potential output of topical compounds.²⁰ Employees can use them to make multiple compounds in small, personalized batches using single use plastic jars and small plastic mixing discs, which remain in the final product jar. Often, topical compounds produced using EMPs have better product quality than those produced by hand.¹⁹ Considered a closed system, these machines also prevent cross contamination. EMPs use a circular or S-shaped blade that spins inside the jar, pushing the cream outwards (toward the jar’s wall). The paddle on each end of the blade creates a forceful, shearing effect and delivers a homogenous and smooth mixture as the process is repeated.²⁰  One limitation to EMPs is they may generate heat during the process, which introduces the possibility that the heat will degrade the active pharmaceutical ingredient.¹⁹ This outcome is highly unlikely because these machines are FAST—they can mix in three to five minutes depending on the product.

 

A planetary mixer is a closed mechanical mixing device used to blend creams, ointments, gels, and viscous formulations.¹⁹ They produce less heat than EMPs. The name comes from the motion of the mixing blade, which rotates on its own axis while traveling around the bowl, similar to a planet orbiting while spinning. Its dual movement provides thorough, uniform mixing and reduces unmixed areas. These mixers are also very fast. Planetary mixers are especially useful for thicker preparations and larger batches, improving consistency and reducing manual effort.¹⁹ However, they require cleaning between batches and may be less practical for very small quantities.

 

In the compounding lab, student Carli is watching a demonstration of the planetary mixer. Several of her classmates are bored and visibly distracted, but she is intrigued. At the end of the demonstration, she stays behind and tells her instructor that she found the whole concept interesting. She says that her classmates often make cupcakes for a fundraising event, and when they make buttercream frosting, the powdered sugar goes everywhere. She likes the idea of a closed system that would incorporate butter, sugar, flavoring, and milk with no mess. She says, “Too bad these are so expensive. They’d be great for frosting!” The instructor asks her to think about it and identify the reason why the planetary mixer would make terrible frosting. It takes a minute, but Carli says, “Ah! It’s because when making buttercream frosting, you need to whip air into it. Planetary mixers press all the air out.” The instructor says, “Correct.” Carli’s friend Sydney is nearby and says, “I guess you can’t make meringue from egg whites in a planetary mixer either!” The instructor nods.

 

An ointment mill is a device used to mix and finely grind ingredients, especially incorporating powders into ointment bases.²² Its main purpose is to reduce particle size and evenly distribute the drug throughout the preparation, producing a smooth, uniform product free of grittiness—that’s called pharmaceutical elegance. This improves both patient comfort and the consistency of dosing.²² Ointment mills reduce particle sizes better than EMPs and compounders who make topicals that contain more than 10% active pharmaceutical ingredient will usually need to use an ointment mill rather than an EMP.²⁰ (If you are wondering, “Why?” see the SIDEBAR.)

 

 

SIDEBAR: The EMP to Ointment Mill Switcheroo!

Kyle is a pharmacy student taking an advanced compounding class. A proctologist has ordered a 20% benzocaine ointment for a patient who has anorectal pain. He has laid out his components and has the EMP ready to mix the ointment. He asks the instructor to check his work. She approves his calculations, but says, “You would be better off using the ointment mill. He says, “Why? I didn’t see anything about this in the USP. Is this some kind of FDA regulation?”

 

She replies, “No universal USP or FDA rule dictates using an ointment mill instead of an EMP if a topical contains more than 10% active pharmaceutical ingredient (API).  Compounders often switch to an ointment mill at higher API loads to improve pharmaceutical quality and address rheology issue. (Rheology is the science of how materials flow, spread, deform, or resist movement under force.)”

 

She goes on to summarize this way:

• At low API concentrations, an EMP can usually generate enough shear and mixing energy to disperse powder uniformly.
• At higher concentrations (especially insoluble powders such as urea, salicylic acid, ketoprofen, zinc oxide, etc.), the formulation behaves more like a dense suspension than a simple cream.
• High solids loading increases
  • agglomeration (the situation in which mall powder particles stick together and form clumps)
  • grittiness
  • poor wetting
  • nonuniform particle distribution
  • risk of dose variability,
  • instability/separation

 

An ointment mill produces much higher and more controlled shear forces than an EMP. The rollers physically reduce particle size and break agglomerates, improving

• content uniformity
• smoothness/elegance
• skin feel
• reproducibility
• and potentially, drug release characteristics.

 

An EMP mainly homogenizes and mixes; an ointment mill both mixes and reduces particle-size.

 

 

Most ointment mills use three rollers that rotate in different directions and at different speeds, creating shear forces that break down particles and blend them thoroughly.²² This process, related to particle size reduction, enhances drug absorption and ensures stable, professional-quality ointment. Using an ointment mill is definitely faster them mixing an ointment by hand.²²

 

Homogenizers create a uniform mixture by reducing particle or droplet size and evenly dispersing ingredients throughout a preparation.²³ They are especially useful for emulsions, suspensions, and creams, where consistent distribution of components is critical for accurate dosing and stability.²³

 

Homogenizers work by applying intense mechanical forces—such as pressure, turbulence, or shear—to break down particles and droplets.²³ By forcing mixtures through narrow channels at high pressure, homogenizers decrease particle size and increase uniformity, leading to better bioavailability. This process improves texture, enhances absorption, and prevents separation over time. The result is a smooth, stable product with consistent therapeutic properties, achieved through principles related to homogenization.²³

 

Capsule filling machines efficiently fill empty capsules with precise amounts of powdered or granulated medication.²⁴ They help ensure consistent dosing and uniformity across multiple capsules, which is especially important when preparing individualized prescriptions.²⁴ Capsule filling machines may be manual, semi-automatic, or fully automatic.²⁵

 

These machines typically align empty capsules, separate the caps from the bodies, fill the bodies with the prepared formulation, and then reassemble the capsules.²⁴ By improving speed and accuracy compared to manual filling, they reduce variability and enhance workflow efficiency. Proper use supports uniform drug distribution and dose accuracy, key aspects of content uniformity. Traditionally, compounders use hard or soft gelatin capsules, which remain widely available and inexpensive. They are not vegetarian, however, as gelatin is a meat byproduct, but there are vegetable-based capsules available. In addition, some gelatin capsules are kosher, but some are not. To be kosher, the gelatin capsules must be made from a kosher source and in a supervised, certified process. Capsules that meet vegetarians’ needs and the needs of people who keep kosher are available and made of cellulose. They tend to be more costly than gelatin capsules.²⁴

 

Of note, 21 U.S.C. § 830 (Controlled Substances Act [CSA] – recordkeeping & reporting) and 21 CFR Part 1310 (DEA regulations on “regulated transactions”) require reporting of certain transactions involving encapsulating machines. These laws define an encapsulating machine as any equipment that will be used to fill capsules with powder, liquid, and others, regardless of the alleged purpose. The CSA legally classifies anyone who sells or distributes these machines as a regulated person and any sale of an encapsulating machine—domestic, import, or export—triggers the requirement to file Form 452 and keep sales records. The purpose of these laws is to scrutinize sales that may be linked to illicit drug production. Note that owning such machines is not illegal; selling them is if the seller does not file a Form 452.

 

Infuser machines ($100 to $400) extract active ingredients from raw materials into a liquid or oil base.^26,27 The term “infuser machine” is colloquial, meaning that’s what just about everyone calls them, mainly because they have been used heavily by the emerging cannabis industry. The scientific names for these machines include²⁷

• solid–liquid extractors
• botanical extraction systems
• maceration/percolation systems
• dynamic extraction devices

 

The infusing procedure extracts compounds from the solid material to the outlet (the liquid in which it is infused), creating a solution that contain colorants, bioactive compounds, and/or fragrances.²⁷ Compounders use these machines to prepare infused oils or solutions by combining heat, time, and controlled mixing to transfer desirable compounds into the final product.²⁶

 

These machines work by maintaining consistent temperatures and agitation, which helps improve extraction efficiency and uniformity.²⁶ This process relies on principles of solid-liquid extraction, including diffusion and osmosis, ensuring that the active components are evenly distributed throughout the preparation for consistent potency and quality. They can infuse a variety of flavors and aromas like milk, honey, butter, oil, or glycerin. They are popular with herbalists and THC/CBD manufacturers.²⁶

 

Interestingly, infusion techniques have become a mainstay of valorization—taking something that would otherwise be considered waste, low-value, or underused and turning it into something more useful or economically valuable.²⁷ In doing so, the process must extract the desirable component while discarding the constituents that are less desirable.²⁸ Some examples include extracting antioxidants from orange peels that would otherwise be discarded; converting agricultural waste into biofuels; using spent grain from breweries to make protein ingredients; and the ever-popular recovering cannabinoids, terpenes, or polyphenols from plant material. Infusion techniques are also very often used in herbal medicine.²⁸

 

Compounders need to appreciate that extraction efficiency increases as particle size decreases because surface area increases.²⁷ That principle is exactly why many infusion machines grind material finely, heat the oil, stir continuously, or cycle between pressure and vacuum.²⁷

 

Molds and presses constructed of silicone or stainless steel ensure uniform shape and size. Many are available in standard sizes, but some can be custom-made. They are employed in both manual and automated compounding. They enhance efficiency with regulated compression force-dosage uniformity. They must be cleaned regularly and thoroughly to meet quality assurance standards.

 

Magnetic stirrers mix liquids using a rotating magnetic field.^29-31 The compounder places a small, coated magnet (“stir bar” or “flea”) in the liquid and then places the container on a plate that has a magnet below it. The stir bar is polytetrafluoroethylene-coated (PTFE which means it is coated in the chemically inert substance we usually know as Teflon). A motor rotates the magnet. The stir bar spins as the field rotates, creating a vortex that mixes the solution uniformly. Some units also include a hot plate for simultaneous heating and mixing. These devices mix the solution consistently, so the final product has uniform dosing and the results are reproducible. Adding heat can make solids dissolve faster and reduce the likelihood of hot spots.^29,30

 

Magnetic stirrers work best with low- to moderate-viscosity liquids.³⁰ They mix creams, ointments, gels, and high-solid suspensions poorly, so for these, a planetary mixer or overhead mixer (a motorized mixer much like a stand mixer in a home kitchen) are better choices. They are also limited to batches of 2 to 4 liters. In addition, if used improperly (at high speeds or improper conditions) they are prone to stir bar decoupling, meaning the stir bar may fail to respond to the magnet completely.³² In addition, compounders need to be certain that their containers are not too narrow or irregularly shaped.³³  And, magnetic stirriers do not reduce particle size.³⁰ Finally, the PTFE coating can chip or degrade over time and the magnet may weaken, potentially compromising mixing and introducing contamination.^31-34

 

Filling machines accurately dispense a defined volume or mass of a preparation into containers (bottles, jars, tubes, syringes).³⁵ Compounders usually use them for oral liquids (solutions, suspensions), topical products (creams, gels, lotions), and occasionally syringes or unit-dose containers. Table 3 lists the several types of filling machines.

 

Table 3. Types of Filling Machines35,36

Volumetric liquid fillers would be best for low- to moderate-viscosity liquids or well-mixed suspensions; they deliver a fixed volume per cycle. These may be piston fillers—which are very accurate and widely used—or peristaltic pump fillers when sterile or clean products are needed. Peristaltic fillers move fluid through a tub using rollers that compress the product. The fluid has contact with the tubing only so contamination is unlikely and cleaning is simple—just replace the tubing. These are less precise if the product is viscous, and the tubs may show wear and tear with use. Auger fillers are used for creams, ointments, and gels. In these devices, a rotating auger screw displaces a controlled amount of the product. These are able to handle higher viscosities than liquid fillers, and they're good for use with jars or wide mouth containers. Some piston fillers are used for viscous products, especially topicals, and in these machines, a high force piston pushes the product through a nozzle. Piston fillers have better control than augers for some formulations. Tube filling machines are used for ointments or creams, and they push the product into an aluminum or a plastic tube. The process is to fill, crimp or seal, and then trim the tube.

 

When using any type of filling machine, compounders need to be aware of some limitations. Filling machines can be influenced by the product’s viscosity, air bubbles, or equipment calibration.^35,37 Of these factors, viscosity is the single most important driver of equipment choice.³⁷ Some machines may develop calibration drift that leads to dosing errors. A PRO TIP is to use gravimetric checks (weight verification) to ensure that their filling machines are accurate.

 

Compounders need to realize that they need to continuously stir suspensions when using filling machines to ensure that the product is evenly distributed. They must also premix creams in an appropriate mixer like a planetary mixer before using the machine. Another limitation is air incorporation. If for some reason the filling machine is incorporating air into the product, the fills will be inaccurate and the product’s stability uncertain; air incorporation is most likely to occur with foaming liquids, gels, or creams. Finally, each of those machines needs to be cleaned thoroughly in accordance with the device’s manual directions between all formulations.

 

Some ophthalmic preparations, oral solutions, and suspensions are only stable within a narrow pH range (see the SIDEBAR).^37,38 pH meters are electronic instruments that measure the acidity or alkalinity of a solution by detecting hydrogen ion activity. The typical device has a glass electrode (sensing element), a reference electrode, and a digital meter that converts voltage into pH units. The measurement the device produces uses electrochemical principles described by the Nernst equation, which relates voltage to ion concentration. Compounders need to know that with some devices, pH readings can change with temperature. (Those that have automatic temperature compensation are less likely to have this problem, but the manual will describe the temperature excursions window in which the device is reliable.) Most machines require thorough cleaning and electrode storage in a potassium chloride solution. They are less reliable in viscous solution, non-aqueous, or solution of low-ionic strength. An example of a low-ionic strength solution is preservative-free artificial tears. They have few dissolved ions (like sodium, chloride, potassium) compared with normal saline or buffered IV fluids, which makes them low ionic strength.

 

 

SIDEBAR: What is pH? The pHacts!^37,38

pHunny you should ask! pH is a way to describe how acidic or basic (alkaline) a pHluid is.

• It is measured on a scale from 0 to 14
• A pH of 7 is neutral (like pure water)
• A pH below 7 means the substance is acidic (like lemon juice or stomach acid)
• A pH above 7 means it is basic or alkaline (like soap or baking soda solution)
• The pH of most body fluids is 7.4

 

A straightforward way to think about it is this: pH tells you how “sour” or “soapy” a liquid would be if you could taste or touch it safely. And not all flavoring can affect pH. Most flavors are acidic and contain citric acid (i.e., lemon or orange), malic acid (apple), or tartaric acid (grape). So flavoring is an active excipient, not just a good taste. Compounders should remember that pharmaceutical-grade flavoring systems are often buffered and standardized.

 

Slight changes in pH can have remarkable effects on drug dissolution, stability, and propensity to be irritating or gentle.

 

 

CONCLUSION

Overall, an efficient compounding company needs well-organized workspaces with designated zones for weighing, mixing, and packaging. Its work areas should be streamlined and well thought out to decrease excess motions and to reduce cross contamination. It is important to follow USP standards closely, and to conduct performance testing.  Use best practices with quality assurance checks and regular sanitization and perform maintenance checks regularly and don’t forget to fill out those training, cleaning, and maintenance logs.

 

When considering a certain machine, managers should ask the manufacturer of the machine for names of companies who have recently purchased the product. Reach out to those companies for feedback on the device. It is also important to let the compounders who are going to use the machine in your compounding company have an opinion.

 

Automated machines eliminate human error and can reduce cross contamination. They can produce compounds which have better consistencies that can increase absorption and enhance comfort. Most importantly, they allow the compounder to create specialized/customized vehicles with adjusted strengths, which opens up more treatment options for our patients.

 

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