Drug compounding is when a pharmacist or doctor combines, mixes or alters ingredients to create a medication tailored to an individual patient's needs.

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It's no surprise that pets, like children, don't want to take their medicine. That's one reason veterinarians prescribe specially made drugs — sometimes beef or bubblegum flavored — to make the medicine go down.

Pharmacists have historically used compounding to change the taste, strength or properties of a manufactured drug or to mix pharmaceutical ingredients. But the Food and Drug Administration has warned some big compounding pharmacies that they cannot sell reformulated medicines for pets or people.

Human medicines ranging from antibiotics to antidepressants can be legally prescribed "off-label" for animals. However, the drug's concentration or medium often needs changing so it is easier to give cats and dogs, ferrets and fish. Even veterinary drugs may need modifying for individual pets.

"Getting the proper dosage or when we need a different form compounded, like an eyedrop for dogs, that's our primary use," said veterinarian George Nyland of Neffsville Veterinary Clinic. He most often orders compounded drugs for kittens, puppies, small dogs and "animals who are difficult to pill, like cats. It would absolutely be a problem for us if these medicines are no longer available," he said.

"No one's going to give a snake, bird, guinea pig or gerbil a pill," added Jeffrey Pendelton, veterinarian at the Harrisburg Pike Veterinary Hospital. "One of the biggest challenges we have in veterinary medicine is that very few animals take their medicine willingly. Some, you can't even force it down their throat."

Birds and reptiles like cherry, grape and bubblegum flavors, he said. "I've seen some birds suck a flavored medicine right out of a syringe."

T. Michael Reed, a pharmacist at Darrenkamp's Pharmacy in Mount Joy, offers 30 flavorings including fish chowder, chicken potpie and Angus beef. He averages 10 to 15 compounded prescriptions a day, half of them for companion animals — even horses, monkeys, snakes, rodents and fish.

"Effectively, everything we compound is made from scratch (because) the veterinary prescription is for an individual animal with individual tastes, needing individual dosages," he said. "I might have to reformulate (because) a small animal needs only one drop of a medication. It's a labor of love. But I love pharmacy and this is a real chance for a pharmacist to practice like in the old days."

Stephen Wiley, a pharmacist at Wiley's Pharmacy, Centerville, recalls compounding Prozac for a parakeet that was plucking out its feathers and making a beef-flavored antidepressant for a German shepherd with separation anxiety.

"I've made compounds for diabetic kitties and dogs with seizures," he said. "Most often, the vet wants some human medication made appropriate for the size of the pet and in a vehicle so the animal will swallow and not think it tastes yucky."

Pendelton said opening a capsule to put a medicine into pet food usually won't work, "because the first thing animals do when they're sick is stop eating. But in liquid form, you can squirt it down their throats and that works. I'm very grateful there are independent pharmacists around to concoct something (special) for a particular animal."

The "route of administration" is most frequently modified for pets, said Diane Boomsma, a pharmacist for 20 years at Williams Apothecary in Lancaster. For example, pills become liquids or, in the case of a common feline hyperthyroid treatment, a human drug is reformulated into a skin gel easily applied to the ears.

Although pharmacy schools still teach "the basic chemical knowledge" to do compounding, most pharmacies don't do this work anymore, said Boomsma, a board member and treasurer of the International Academy of Compounding Pharmacists. Many compounding pharmacists receive added training.

She said compounding can create "oral liquids, creams, eye drops, ear preparations, injectables, wound powders, inhalation medication and suppositories" from other formulations so "an animal will accept it and an owner will remember to give it."

Compounded drugs also are prescribed when a manufactured drug is off the market, a raw chemical is not manufactured as a drug or the manufactured drug has multiple ingredients that may not be advisable for the pet. In such cases, pharmacists may make a medication from bulk ingredients — and that's the main aspect of compounding the FDA is targeting.

"There is a federal law which allows compounding on a case-by-case basis. A legitimate compounding pharmacy, if following the FDA guidelines, is not going to be shut down," said Mark Papich, a pharmacology professor at North Carolina State University and member of the Veterinary Medicine Advisory Committee to the FDA. "What the FDA has been attempting to do is limit the use of bulk chemicals which (compounding) pharmacies will mass-produce to sell to vets or others … to circumvent the new-drug approval process."

He argued compounding pharmacies are essentially unregulated, "and some might be dispensing medications that are worthless."

Boomsma countered, "Some compounders are small and some (are) large, but compounding — whether for humans or for animals — has rigid quality control standards … regulated by our state boards of pharmacy. The FDA is trying to usurp that authority."

Consumers should be aware not all compounding pharmacists have the same training or equipment, Boomsma said, but the FDA "would like to see every prescription go through the new-drug approval process, which is absurd and would effectively end all compounding."

"As long as the pharmacist has done his research, the product ingredients are verified and it's been prescribed to do a job for one patient, then the pharmacist has done his duty," agreed Reed.

George Lehman, of Maytown, is one owner using a compounded bulk chemical. His dog, Cadence, takes potassium bromide which is compounded into a beef-flavored liquid. Prescribed in addition to a manufactured epilepsy drug (phenobarbitol), the medications are now limiting the grand mal seizures Cadence has suffered for five years.

Not all compounded drugs are proven, noted Cindy Albright, veterinarian at the Donegal Animal Hospital. "We don't have enough research on a lot of medicines to know whether they'll get absorbed properly, for example, when turned into a transdermal gel. We may not know if a drug is as effective if not in pill form."

For that reason, "a vet has to keep close tabs when using any compounded drug, but that's true with any medicine used off-label," she said.

Compounding is necessary because "I couldn't cut a capsule down into sixteenths to get an accurate dose for a small animal.

"If we weren't able to give these compounded drugs, we wouldn't be able to treat some of the diseases we're treating effectively now," Albright added. "It's important for us to have these medications available … or it would be a disaster."

Public has its say

In August, a federal appeals court judge in Midland, Texas, ruled compounded drugs were not new drugs and compounding from bulk pharmaceutical ingredients was legal for non-food-source animals. The FDA has appealed.

In response, the International Academy of Compounding Pharmacists developed a Web site to gather public testimonials — Patients and Professionals for Customized Care at www.savemymedicine.org — that pharmacist Diane Boomsma said allows "vets and owners (to) stand up and say: 'I need this for my animal.' "