Know laws, responsibility regarding legal pharmacy compounding

Know laws, responsibility regarding legal pharmacy compounding

Nov 01, 2003

Veterinarians are often unclear on the differentiation and clinical ramifications of the use of pioneer and generic drugs and registered products, medical devices and pharmacy compounded products. In addition, what are the laws that revolve around these issues?

Definitions Drug piracy

Ethical pharmacies provide drug formulation for special needs and when no other similar route active ingredient is available.

Drug piracy is the mimicry of Food and Drug Administration (FDA) approved drugs. The pirated formulations are sold under the guise that one can expect the same quality, clinical safety and efficacy as compared to FDA-approved products. It is impossible for a drug pirate (often disguising themselves as a compounding pharmacist) to formulate a product with the same quality, purity and stability of an FDA-approved product and assure efficacy and safety. Licensed pharmacists know they can't produce products of the same quality as FDA-approved formulations. Examples of drug piracy include attempts to mimic AdequanTM, GastrogardTM, KetofenTM, BanamineTM, Hylartin-V-TM, RimadylTM, EnalaprilTM, MetacamTM, etc. This practice is initiated by the ignorance or avarice or both on the part of the pirate, and supported by either the ignorance or avarice or both of veterinarians.

Added to the spectrum of activities of some drug pirates is the promotion of untested drugs and untested routes of administration, as if they have data to support this information (e.g., topical drug administration of antibiotics for systemic disease).

Drug compounding

There are two kinds of drug compounding.

1. Drug compounding may involve the alteration of FDA-approved products. An example would be mixing AcepromazineTM and RompunTM in the same syringe at the patient's side. There is a provision in the law for this practice under the Federal Food, Drug and Cosmetic Act, Animal Medicinal Drug Use Clarification Act (AMDUCA). Alteration of FDA-approved products will not be covered in this article.

2. The more important form of compounding relative to this article is the compounding of bulk chemicals to form a new product. The focus of this article is drug compounding from bulk products to create a new formulation.

Bulk products

Photos 1 and 2: Pirated "enrofloxacin" created from smuggled-into-the-country "enrofloxacin", specifically made to treat food animals.
Bulk products are basically chemicals in drums, boxes, bags and bottles. In the case of most bulk drug products used by drug pirates in veterinary medicine, the products are often smuggled into the United States and come from India, Pakistan and China. The quality of these products is always questionable. There is no guarantee of the products' strength, content and purity (e.g., How much active hyaluronic acid of a known molecular weight is in the powder? Is there hyaluronic acid in the powder? What else is in the powder?).

Legitimate pharmacy compounding

Pharmacy compounding is the legitimate activity of drug formulation to produce a product for medical management. Formulation is performed by a licensed pharmacist when no other FDA-approved choice is available (e.g. dipyrone injectable or KBr). Prescription and labeling guidelines must be followed. Many compounding pharmacies produce excellent products, follow the law and Good Compounding Practices guidelines and care about patients. Unfortunately, many drug pirates are licensed pharmacists, but producing a pirated drug is not legitimate compounding pharmacy.

Pioneer, generic, registered drugs

Pioneer, generic and registered drugs all have FDA approval. All are manufactured under Good Manufacturing Practices (GMP) legislation and guidelines. Pioneer drugs are the original product under which drug sponsors collected efficacy and safety data for FDA approval. Generic drugs are drugs that are allowed to be marketed based on essentially matching pharmacokinetics to the pioneer and the determination that the constituents of the product provide no safety risk. As with pioneer products, generic products require FDA approval. Registered products are intravenous fluids, vitamins with no claim, but are allowed to be marketed by FDA and still undergo GMP manufacturing criteria.

A common misconception by veterinarians, and often indicated by drug pirates, is that pirated drugs are generics. That is completely wrong!

Pirated drugs have no claim to drug quality, purity and stability. The bulk product is often made in laboratories in China, India and Pakistan. No bulk drug intended for use in veterinary species is allowed to be imported into the United States. Therefore, all of the bulk chemicals used in drug piracy have been imported illegally. Is this a Homeland Security issue?