Compounding Pharmacy Policy Initiatives 

 

January 2017: Compounding Federal Guidance

FDA Releases Additional Compounding Guidance Documents

In mid-January, FDA released a final guidance addressing the repackaging of certain human drug products by pharmacies and outsourcing facilities. In the guidance, FDA lays out the situations where it does not intend to enforce certain federal regulations with regard to repackaging drugs by state-licensed pharmacies, federal facilities, or registered outsourcing facilities. The guidance also clarifies FDA's definition of repackaging to mean "the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug." While FDA says repackaged drugs are "generally not exempt from any of the provisions of the [Food, Drug, and Cosmetic Act] FD&C Act related to the production of drugs," the agency does not intend to enforce these provisions against state-licensed pharmacies, federal facilities, or outsourcing facilities as long as they meet the criteria set out in the guidance. 

NCPA had previously relayed a host of concerns with the draft guidance to FDA, especially in regards to long term-care pharmacy repackaging practices. Fortunately, the FDA heard their concerns and states within the guidance that for the meantime FDA does not intend to address non-sterile drug products repackaged by State-licensed pharmacies for use in long-term care facilities and will instead revise the guidance or issues separate guidance to address this issue.  The FDA also announced revisions to a previous final guidance document addressing 503A bulk drug substances and released the following compounding progress report: FDA'S Human Drug Compounding Progress Report: Three Years After the Enactment of the Drug Quality and Security Act. 

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