FDA recently issued five new documents related to drug
compounding and repackaging to provide compliance information to
pharmacies, physicians, and outsourcing facilities engaged in the
compounding of human drugs. Under the Drug Quality and Security Act
("DQSA"), which was enacted in response to a deadly
fungal meningitis outbreak, human drug products compounded by or
under the direct supervision of a licensed pharmacist in a
registered outsourcing facility can qualify for exemptions from
FDA's drug approval requirements and certain other drug
labeling and track and trace requirements. These provisions created
a new section 503B of the Federal Food, Drug, and Cosmetic Act
("FDCA"). However, to qualify for these exemptions under
503B, outsourcing facilities, also referred to as compounding
pharmacies, must meet several conditions. Many of the specific
requirements and parameters provided for compounding under the DQSA
remained unclear. The new documents are intended to provide
clarification to such issues.
The draft guidance on registration provides a
comprehensive list of the conditions that must be met for an
outsourcing facility to qualify for the 503B exemptions and
clarifies that registering with the FDA as an outsourcing facility
indicates the intent of that facility's compounded drugs to be
compounded in accordance with, and regulated under, FDCA Section
503B. FDA issued two draft guidance documents to further outline
policies not addressed in the laws on compounding—a draft guidance on repackaging describes
FDA's enforcement policy for repackaging compounded drugs (not
including biologics), and a draft guidance on biologics describes
FDA's enforcement policy for biological products that are mixed
or repackaged without an approved biologics license application.
The draft guidance on reporting explains the
requirements for adverse event reporting for outsourcing
facilities. Finally, the draft memorandum of understanding
("MOU") describes the responsibilities of a state that
elects to sign on to the MOU for handling complaints related to
compounded drugs and distribution of statutorily determined
"inordinate amounts" of compounded drugs.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
