Macro photo of tooth wheels with COMPLIANCE, REGULATIONS, STANDARDS, POLICIES and RULES words imprinted on metal surface

Thought FDA Was Tempering Back Its Oversight and Enforcement of Compounding Operations? Think Again!

Commissioner Dr. Scott Gottlieb shared FDA’s 2018 Compounding Policy Priority Plan (here) providing an overview of the Agency’s key priorities to implement (and enforce) the federal law on compounding (Drug Quality and Security Act [DQSA], signed into law November 2013). He also states that this plan advances FDA’s mission to protect the health and safety of the public.

FDA wants to ensure that compounded medicines are made according to appropriate quality standards and to clarify and tailor policies for traditional compounding pharmacies (503As) and outsourcers (503Bs).

Note that Dr. Gottlieb states that all the Plan’s initiatives will be executed in 2018 and lays out how the agency will implement (and enforce) the DQSA framework. The policies will be part of a series of draft and final Guidances, proposed and final Rules, and a revised draft Memorandum of Understanding (MOU) between FDA and States. The 2018 compounding policy priorities include: preserving access to compounded products (preparations); protecting the public from poor quality compounded drugs; and continuing to protect the new drug (and generic) approval process.

For now, 503B outsourcers must be registered with FDA, must provide biannual list of all compounded preparations (and volumes), must report adverse events and must meet drug manufacturing GMP regulations. FDA, as part of this plan, will reissue Guidance on risk based approaches to GMP compliance taking into account the size and complexity of the 503B facilities’ outsourcing operations.

Traditional compounders (503A) must meet USP requirements in USP chapters <795>, <797>, <71>, <85>, <1075>, <800>, <1160>, <1163> and other applicable chapters and state regulations.

The 2018 Plan includes issuance of two Guidance Documents, one for 503A and one for 503B compounders, which restrict compounding of drugs that are essentially copies of FDA approved drugs to protect both the public health and the premarket approval process for new and generic drugs. FDA defines what is and what is not compounding of drugs that are essentially copies of commercial products. An exception is that DQSA allows 503A and 503B entities to compound drugs on the current FDA Drug Shortage List (see here and here for these guidance documents which will be subject of further posts in this series).

The goal of these Guidances is to make sure patients do not receive compounded drugs when an FDA approved drug is appropriate to meet the patient’s needs.  These Guidances were issued within days after the Plan was shared.

Another Guidance already issued is “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application” (here)  where FDA will consider allowing a science- and data-driven process for extending beyond-use dating for mixed, diluted or repackaged (not compounded, which is not allowed) biological products beyond the default 24 hours or provisions in the BLA.

The 2018 Plan also addresses comments made the draft Guidance on MOUs with the States, and a new Guidance will be issued to address the percentage of drugs that can be distributed interstate from 30% to 50% with new triggers for reporting after these levels are reached. The new Guidance on MOUs would clarify what activities will be overseen by FDA and/or the states.

The 2018 plan also calls for FDA to clarify policies on whether 503Bs can also manufacture FDA approved drugs within the same facility and to clarify if there can be a separation between 503A and 503B operations in the same facility or location.

This is an extensive plan and it is highly recommended that impacted parties read this plan and subsequent Guidances, Proposed and Final Rules, and other FDA correspondence based on execution and enforcement activities.

This is the first part of a series of blogs on these matters.