FDA issues proposals to implement statutory restrictions on compounding drugs that are essentially copies of commercially available or approved drugs
Proposals would preserve access to compounded drugs for patients who need them
Today, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents describing how the FDA would implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products. The draft guidance documents apply to pharmacies, physicians, federal facilities, and outsourcing facilities.
Compounded drug products pose a higher risk to patients than FDA-approved drug products because FDA does not evaluate them for safety, effectiveness, and quality before being used. In addition, some compounders are not required to comply with current good manufacturing practice requirements. Taking poor quality compounded drugs has resulted in serious adverse events, including infections and death, in many patients.
Compounded drug products may benefit certain patients whose medical needs cannot be met by a commercially available or an FDA-approved drug product. For example, compounded products may help a patient who has an allergy to a certain dye and needs a medication to be made without that dye, an elderly patient who cannot swallow a pill and needs a medicine in a liquid form that is not otherwise available, or a child who cannot take an adult-strength pill and needs a drug in a strength that is lower than that of the approved drug product.
However, taking compounded drug products that are essentially copies of a commercially available or approved drug needlessly exposes patients to drug products that FDA has not evaluated for safety, effectiveness, and quality. In addition, the compounded drugs may not have been produced according to appropriate quality standards. Such compounding would also undermine the new drug approval and over-the-counter drug monograph systems in the United States.
The two draft guidance documents are:
- Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB)
- Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 347KB)
The public comment period on these draft guidance documents closes in 90 days.