The Roles Of Compounding Pharmacies

In the past, the only place patients could go for medications was to a compounding pharmacy. The pharmacist would create a product using raw ingredients kept on the premises. This process changed in the early 20th century with the rise of pharmaceutical companies and an increased concern about safety and efficacy.

Today, the vast majority of medicines are made by drug manufacturers that have to meet government regulations on the products they make. However, compounding pharmacies are still a necessary component for the delivery of medication. There is still a need for custom prescriptions to be made for individual healthcare patients. This need for custom medicine is why it is important to understand the legal definition of a compounding pharmacy and the implications to a compounding pharmacy if it is deemed a drug manufacturer.

The legal definition of a compounding pharmacy

The Federal Food, Drug and Cosmetics Act (FFDCA) requires all facilities which manufacture, prepare, propagate, compound, or process drugs to register every year with the FDA. There is an exception for retail pharmacies, which do compounding as part of regular operations.

The problem comes in trying to distinguish between pharmaceutical drug manufacturers and compounding pharmacies.

When a compounding pharmacy is deemed a drug manufacturer

In 2002, the FDA reissued Compliance Policy Guide 460.200 for guidance on how the agency would distinguish between traditional compounding pharmacies and drug manufacturers. The guide outlined certain acts which would be considered going beyond the traditional role of compounding pharmacies and those that the FDA would consider drug manufacturing.

A pharmacy cannot compound drugs in anticipation of receiving prescriptions. The only exception to this rule is limited quantities produced as excess while compounding drugs after receiving a prescription. To compound before receiving prescriptions is the action of drug manufacturers, not traditional compounding pharmacies. Compounding pharmacies cannot produce drugs which have been withdrawn or removed from the market due to safety concerns. If a product has been removed for safety reasons and a pharmacy recreates and sells it, that pharmacy is acting as a drug manufacturer.

Compounding pharmacies cannot use active ingredients which are not components of FDA approved drugs. All active ingredients must have passed an FDA new drug application investigation. A pharmacy is also prohibited from buying, storing, or using substances that are not made in an FDA-registered facility. The supplier should provide written assurance of this rule for each substance.

A pharmacy cannot sell compounded drugs to third parties for resale. The role of compounding pharmacies is to create custom drug mixtures for a single patient with a valid prescription, not to manufacture them for sale by another party. Compounding pharmacies cannot produce drugs that duplicate drugs currently on the market or copies of FDA-approved products. The only exception is producing a small quantity of such a product that is only slightly different to meet the needs of a particular patient. Full documentation of the medical need for the variation must be kept by the compounding pharmacies that produce drugs in this manner.

These regulations are not all that the FDA requires of compounding pharmacies. That is why such pharmacies need the help of qualified healthcare attorneys. Contact the attorneys at Brown & Fortunato, P. C. at (806) 345-6300. You can also connect with us on our Contact Us page. Our website offers a full review of our other practice areas. Feel free to visit our law offices at 905 S. Fillmore, Suite 400, Amarillo, Texas.

This information is subject to change. Please check for updates that are more recent than the published date of this article.