Actions Following the FDA Compounding Priorities Plan

Last January, the FDA released its 2018 Compounding Priorities Plan to outline how the agency intended to implement certain key aspects of the Drug Quality and Security Act (DQSA) and other provisions of applicable law related to compounding.

Specifically, the plan detailed how the FDA would:

1. Address manufacturing standards for outsourcing facilities.
2. Regulate compounding from bulk drug substances.
3. Restrict compounding of drugs that are essentially copies of FDA-approved drugs.
4. Solidify the FDA’s partnership with state regulatory authorities.
5. Provide guidance on other activities that compounders undertake.

The FDA took substantive actions regarding these 5 categories last year and hopes to address all 5 by the end of 2019. The agency’s 2018 policies and actions related to compounding were largely based on its stated objectives of balanc- ing access to necessary compounded drug products and aiming to ensure the utmost safety of compounded drug products. It is important to keep in mind that the FDA has stated that compounded drug products can pose unique risks.

What follows is an overview of the FDA’s policies and actions related to the plan. 

Address Manufacturing Standards for Outsourcing Facilities

The FDA stated that it was looking to make the process of becoming an outsourcing facility more efficient and less costly in order to encourage more traditional compounding pharmacies to become outsourcing facilities. To that end, the agency planned to issue proposed regulations on specific current good manufacturing practice (CGMP) requirements that pertained to outsourcing facilities. Drug products compounded by 503B outsourcing facilities are not statutorily exempt from current CGMPs; however, there are currently no specific CGMP regulations for outsourcing facilities. Presumably, the FDA likely anticipated that issuing such regulations would take some time. In the interim, the FDA also proposed revising a draft guidance to describe a new flexible risk-based approach to CGMP requirements for outsourcing facilities.

On December 10, 2018, the FDA issued a revised draft guidance regarding CGMP standards for outsourcing facilities. The guidance includes revisions related to release testing, stability testing, and beyond use testing, “as well as policies that differentiate between production of sterile and non-sterile drug products.”

The FDA is also holding a public meeting in May 2019 to solicit comments from stakeholders on the revised draft guidance.

Regulate Compounding from Bulk Drug Substances

503A Traditional Compounders

According to the Federal Food, Drug, and Cosmetic Act (FD&C Act) section 503A, 503A facilities may compound drugs using bulk drug substances that:
  • Comply with existing United States Pharmacopeia (USP) or National Formulary monograph standards.
  • Are components of FDA-approved drugs.
  • Appear on the 503A bulks list, developed by the FDA through regulation, after consultation with USP and the Pharmacy Compounding Advisory Committee.
The FDA is working toward finalizing the 503A bulks list through regulation. In December 2016, the FDA released a proposed regulation, in which it proposed placing 6 nominated substances on the list and excluding 4 other substances. The agency continues to consult with the Pharmacy Compounding Advisory Committee.

Meanwhile, the FDA has issued an interim 503A list delineated into 3 categories. As the FDA finalizes the list, it does not intend to take action against a compounder that is using bulk drug substances listed in category 1—substances potentially eligible for the final list— assuming the conditions in the interim bulks policy are met.

In July 2018, the FDA issued a compounding risk alert regarding cesium chloride and moved the substance into category 2 of the 503A bulks list.

503B Outsourcing Facilities

According to DQSA, 503B outsourcing facilities may use a bulk drug substance to compound a drug that complies with the FD&C Act if the FDA has determined that there is a clinical need to compound with the substance and places it on the 503B bulks list or if the compounded product appears on the FDA’s drug shortage list.

In March 2018, the FDA reissued draft guidance for evaluating bulk drug substances for the 503B list, which details the FDA’s interpretation of “clinical need” and factors that the agency intends to consider when determining whether to include a bulk drug substance on the final 503B bulks list.

The criteria of March 2018 guidance are arguably much more stringent than those of the prior policy, which was used for the inclusion of bulk drug substances onto the interim 503B bulks list.

The FDA took steps to implement the most recent guidance approximately 4 months after it was issued. The FDA proposed that 3 substances included in category 1 of the interim list would not be included on the final list when it is implemented. The FDA opened a comment period on the Federal Register for interested stakeholders to weigh in on such action.

Restrict Compounding Drugs That are Essentially Copies of FDA-Approved Drugs


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