Report Language for FDA Appropriations Bill Includes Directions About Compounding

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The report language for the bill that funds the Food and Drug Administration (FDA) has been released by the U.S. House of Representatives Committee on Appropriations. While this language does not have the force of law, it instructs federal agencies on actions to take as part of accepting new funding from Congress.

Here are excerpts that relate to compounding pharmacy: 

Animal Drug Compounding

The Committee wants to ensure that GFI #256 on animal drug compounding, which FDA issued on November 20, 2019, does not create the same issues that resulted in withdrawal of the previous draft guidance, GFI #230. The Committee expects that any finalized guidance on compounding for animal health will preserve treatment options available to veterinarians, will reflect public input, and will recognize the need for compounded medications by pet owners, animal shelters, zoos and other stakeholders. 

Automated Compounding

The Committee encourages FDA to review policies, regulations, and guidance to incorporate and incentivize the use of automation technology to enhance safety, improve accuracy, and facilitate compliance in drug compounding. 

Compounding Center of Excellence

The Committee supports the development of the Compounding Center of Excellence, which expands engagement with outsourcing facilities regarding good manufacturing practices, thereby helping these facilities adhere to the quality standards needed to protect patient health and support sector growth in small, underserved communities. The Committee encourages FDA to make concerted efforts to advise small compounders on how best to navigate regulations concerning distributing and dispensing practices, so these businesses may continue to adequately service local communities and individual patient needs.

Drug Compounding and Final Memorandum of Understanding (MOU)

The Committee recognizes the FDA recently finalized the MOU for pharmacy compounding. The Committee requests that FDA engage further with stakeholders to address concerns and to ensure that all or nearly all states can sign this important document. 

Drug Compounding Pharmacist on Pharmacy Compounding Advisory Committee

The Committee recognizes that the Pharmacy Compounding Advisory Committee established under the Drug Quality and Security Act (DQSA) needs to adequately represent the interests and needs of providers and patients who use and depend on compounded medications. Compounding is often practiced in community settings. It is therefore vital that voting members of PCAC have a thorough understanding of compounding in a community setting in order to appropriately advise FDA. The Committee encourages FDA to appoint qualified voting members with recent, actual, and diverse experience in the preparation, prescribing, and use of compounded medications. 

DQSA Implementation

The Committee is aware of concerns about FDA’s implementation of the DQSA as it relates to USP dietary supplement monographs. Last year’s House Report directed the FDA to brief the Committee with an update on the issue, the Committee looks forward to receiving the briefing. 

Office Use Compounding

The Committee continues to hear concerns that FDA has implemented and enforced the DQSA through guidance for industry documents rather than through the notice and comment rulemaking procedure called for by the underlying statute and the Administrative Procedures Act. The Committee looks forward to receiving a briefing from FDA on this issue