New FDA Guidance for Compounding Facilities

The FDA today issued 5 draft documents about drug compounding and repackaging, which will be useful to pharmacies, federal facilities, outsourcing facilities, and physicians.

After a deadly fungal meningitis outbreak in 2012 related to a compounding pharmacy, the Drug Quality and Security Act (DQSA) was enacted by Congress.

Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), national companies that prepare compounded sterile medications in advance of a patient prescription can elect to register with the FDA as an outsourcing facility. According to the FDA, drugs compounded in an outsourcing facility that meet certain conditions may be exempted from some provisions of FD&C. For example, some outsourcing facilities may be exempted from the new drug approval requirements and the requirement to label drug products with adequate directions for use.

Compounders that are not registered as outsourcing facilities should meet other conditions of the FD&C Act or they will be subject to the requirements for drugs made by conventional manufacturers, according to the FDA.

These 5 documents are the latest in a series of policy documents that assist companies that compound drugs with registering as outsourcing facilities. Back in November 2014, the FDA issued 3 other policy documents.

The newest guiding documents relate information on a variety of topics:

• For entities considering whether to register as outsourcing facilities under the FD&C Act, this document provides information about the regulatory impact of registering, For example, facilities that only engage in specific activities like repackaging human drugs and compounding nonsterile drugs should not register as an outsourcing facilty because its drug products will not qualify for the exemptions in section 503B.
• This document tackles the conditions under which the FDA does not intend to take action for certain violations of the law when state-licensed pharmacies, federal facilities or outsourcing facilities repackage certain drug products.
• This guidance describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act and the FD&C Act when state-licensed pharmacies, federal facilities, or outsourcing facilities mix, dilute or repackage specific biological products without an approved Biologics License Application (BLA), or when such facilities prepare prescription sets of allergenic extracts without an approved BLA.
• This draft delves into adverse event reporting for outsourcing facilities.
• This guidance describes the responsibilities of a state that signs the memorandum of understanding in investigating complaints related to compounded drugs distributed outside the state.

“The draft guidance documents provide information to pharmacies, outsourcing facilities, health care entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.

These documents will be available for public comment for 60 days.