Veterinary Compounding

What is compounding?

Compounding that is consistent with the FDA Extralabel Drug Use regulations is the customized manipulation of an approved drug(s) by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient. For example, mixing two injectable drugs is compounding. Preparing a paste or suspension from crushed tablets is another example of compounding. Likewise, adding flavoring to a drug is compounding. Be aware, however, that products are being promoted to veterinarians under the guise of compounding that do not fit this definition. According to the FDA, legal compounding is not the formulation of preparations from bulk or raw active ingredients. Compounding should not be used as a way of circumventing the drug approval process or producing a product so it can be sold for less cost than an FDA-approved drug.

Federal regulations to follow

The FDA regulations and Compliance Policy Guide 608.400 “Compounding of Drugs for Use in Animals” describe specific circumstances under which FDA will either permit compounding for use in animals or may exercise its enforcement discretion where:

• A valid veterinarian-client-patient relationship exists.

• The health of an animal is threatened, or suffering or death may result from failure to treat.

• Compounding is performed by a licensed veterinarian or a licensed pharmacist on the order of a veterinarian within the scope of professional practice.

• There is no approved animal or human drug that, when used as labeled or in conformity with the extra-label drug use regulations, will, in the available dosage form and concentration, appropriately treat the condition diagnosed.

• Preparations are compounded from FDA-approved animal or human drugs. Nothing in the regulations permits compounding from bulk (raw pharmaceutical ingredient) drugs.

• Compounding from a human drug for use in food-producing animals is not permitted if an approved animal drug can be used for the compounding.

• For animals produced for human consumption, the veterinarian institutes procedures to assure the identity of treated animals, establishes a substantially extended withdrawal interval for the compounded preparation supported by appropriate scientific information, and ensures food safety. Compounding is not permitted if it results in violative food residue, or any residue that may present a risk to public health.

• No drug may be compounded for food animals from drugs listed on the prohibited list (go to www.fda.gov/AnimalVeterinary/  and enter “530.41” in the search engine).

• Veterinarians comply with all aspects of the federal extra-label drug use regulations including record-keeping and labeling requirements.

• Adequate procedures and processes are followed that ensure the safety and effectiveness of the compounded product.

• The scale of compounding in advance of receiving prescriptions is limited and  commensurate with the established need for compounded products.

• All relevant state laws relating to the compounding of drugs for use in animals are followed.

Compounding from unapproved substances

Federal regulations describe specific circumstances under which veterinarians, or pharmacists upon veterinarians’ prescriptions, are legally permitted to compound drugs for extralabel use in animals. Under
these regulations, compounding for non-food animals may only be performed using FDA-approved animal or human drug products and only when there is no approved animal or human drug product available in the relevant dosage form and concentration to appropriately treat the diagnosed condition. Compounding from human drugs for use in food animals is not allowed if an approved animal drug can be utilized.

However, veterinarians may occasionally face situations where they diagnose conditions for which no FDA-approved product is available for use to relieve the animal’s suffering or prevent the animal’s death. The current state of veterinary medicine requires products to treat many conditions in a number of different species, some of which are known to have unique physiological characteristics. Although the FDA considers it a violation of the Federal Food, Drug and Cosmetic Act, it acknowledges the need for compounding from bulk active or raw ingredients within certain areas of veterinary practice. For example, the FDA published a list of bulk drug substances for compounding and subsequent use in animals to which FDA would exercise enforcement discretion and not ordinarily object, specifically poison antidotes available only as bulk chemicals. In these situations or others, veterinarians may find it necessary to compound, or prescribe for a pharmacist to compound, from the bulk chemical to satisfy the requirements of good veterinary medical practice. The veterinarian and/or pharmacist are then responsible for the safety and efficacy of the compounded drug. In cases where no approved drug or combination of approved drugs can adequately address a specific patient’s need, veterinarians and pharmacists must carefully assess whether the use of an unapproved substance in a compounded veterinary drug is consistent with state and federal law and FDA policy.

Compounded preparations are not generic drug products

Generic drug products are very different from compounded preparations. Generic drug products are FDA-approved, which requires a demonstration of bioequivalence of safety and efficacy with the pioneer drug product. Generic animal drug products are identified by an Abbreviated New Animal Drug Application (ANADA) number on their label or in FDA drug references. In contrast to generic drugs, compounded preparations lack FDA approval.

How to identify an FDA-approved animal drug product

FDA-approved animal drug products can be identified by the six-digit New Animal Drug Application (NADA) number for brand-name drug products or the six-digit ANADA number for generic drug products. The NADA or ANADA number and the statement “Approved by FDA” can usually be found on the drug product’s label including the package insert. It may also be helpful to cross-check with a drug reference, such as the FDA’s online databases, Animal Drugs @FDA and FDA Orange Book, which list approved animal and human drug products, respectively. The presence of a National Drug Code (NDC) number on a product label does not confer FDA approval.

Inappropriate compounding pharmacy practices

Inappropriate compounding pharmacy practices include the following:

Compounded preparations that mimic FDA-approved drug products. Beware of pharmacies that purport to sell compounded preparations that are the same as commercially available FDA-approved products or similar but with a minor difference, such as a slightly different concentration. Often these are marketed as a cheaper alternative to the approved drug. The FDA has not identified price as a legitimate reason for prescribing a compounded preparation.  Legitimate compounding is prescription-driven and predicated upon the need to customize a preparation to meet an individual patient’s needs.

 

Manufacturing under the guise of compounding. The use of commercial scale equipment and preparation of large quantities of compounded products in anticipation of receiving orders.

Promotion and advertising of unapproved new animal drugs. FDA considers products compounded from bulk active ingredients to be unapproved new animal drugs.

Wholesale distribution of compounded preparations. It is not legal for compounded preparations to be developed in large quantities and sold to third parties (including veterinarians and companies) and/or wholesalers, to resell to individual patients.

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