Reed Smith Client Alerts

On November 6, 2020, the Food and Drug Administration (FDA or Agency) published its final Guidance for Industry, “Insanitary Conditions at Compounding Facilities” (Final Guidance). The Final Guidance comes four years after the Agency first published its draft guidance on this subject and two years after FDA revised its position and requested further comment from industry stakeholders, previously analyzed by Reed Smith. The Final Guidance remains largely consistent with its predecessors, against which compounding facilities have been inspected by FDA since 2016. While “final,” the Final Guidance does not establish any legally enforceable responsibilities on compounding facilities, but instead memorializes FDA’s non-binding current thinking on this topic.

Application to compounding pharmacies and outsourcing facilities

Sections 503A and 503B of the federal Food, Drug, and Cosmetic Act (FDCA or Act) exempt state-licensed compounding pharmacies and federally registered outsourcing facilities (together, compounding facilities) from specified provisions of the FDCA if certain conditions are met. FDA has consistently taken the position, however, that neither of those sections exempts compounding facilities from the Act’s adulterated drug product provision. It is FDA’s stance that pursuant to Section 501(a)(2)(A) a compounded drug product is deemed adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health…” 21 U.S.C. 351(a)(2)(A) (emphasis added). It is important to further note that the Final Guidance governs the compounding of both sterile and non-sterile drug products.

Final Guidance generally consistent with predecessors, with a new emphasis on risk management

The Final Guidance, like its predecessors, provides a non-exhaustive list of observations that the Agency has made during one or more inspections and that it considers to constitute insanitary conditions. The list is almost identical to that provided in the predecessor draft and revised guidances, with a few notable exceptions that apply to:

  • the mixing or reconstituting of beta-lactam drug products at the immediate point of dispensing for in-office administration;
  • the handling of radiopharmaceuticals in ISO-5 classified areas; and
  • facility design issues that result in a pattern of frequent or acute air pressure reversals between areas of lower and higher air cleanliness.