The U.S. Food and Drug Administration on Jan. 24 issued its 2018 Compounding Policy Priorities Plan, which outlines how the agency will implement key aspects of the Drug Quality and Security Act and other provisions of the law relevant to compounders.
That law was enacted after a fungal meningitis outbreak in 2012 stemming from the New England Compounding Center Inc. sickened at least 751 people and killed 64 of them. That outbreak, combined with FDA’s continued concerns about monitoring pharmacy compounding, underscored the need for improvement in compounding practices, according to the agency, and the law, passed in 2013, boosted oversight of compounders and gave FDA tools to address unlawful practices that threaten public health.
FDA noted that the law created a new category of compounders, called outsourcing facilities, which may engage in larger-scale, nationwide distribution under additional FDA oversight.
The agency said its 2018 Compounding Policy Priorities Plan details how FDA will:
- address manufacturing standards for outsourcing facilities
- regulate compounding from bulk drug substances
- restrict compounding of drugs that are essentially copies of FDA-approved drugs
- solidify FDA’s partnership with state regulatory authorities
- provide guidance on other activities that compounders undertake
As part of its implementation of the plan, FDA also issued two final guidance documents explaining its policies on the “essentially a copy” provisions of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Ac and guidance on mixing, diluting, or repackaging biological products.