FDA released three new draft guidance documents regarding its implementation of the human drug compounding requirements of Title I of the Drug Quality and Security Act, the "Compounding Quality Act." Fundamentally, the draft guidance documents describe FDA's current thinking on the prescription requirement for human compounded drugs, how it intends to apply the prescription requirement to compounding occurring in a hospital or health system pharmacy, and how the Agency defines "facility."
Section 503A of the Federal Food, Drug, and Cosmetic Act ("FDCA") outlines what conditions must be met for human drugs compounded by a licensed pharmacist in a state-licensed pharmacy or a licensed physician in order to be exempt from the manufacturing, labeling, and new drug application requirements of the FDCA. Section 503B establishes "outsourcing facilities" and lists the conditions that must be met for human drugs compounded by or under the direct supervision of a licensed pharmacist in such facilities to be exempt from the labeling, new drug approval, and track-and-trace requirements of the FDCA. Products made by an outsourcing facility remain subject to manufacturing requirements.
Prescription Requirement Under Section 503A of the FDCA. A compounded drug product may be exempt under Section 503A only if it is compounded in conjunction with a valid prescription. The guidance discusses compounding that occurs after the receipt of a prescription for an individual identified patient, before the receipt of a prescription for an individual identified patient (referred to as "anticipatory compounding"), and for office use. The guidance describes what constitutes receipt of a valid prescription order or notation approved by the prescriber, when a drug can be compounded, and recordkeeping. FDA states that it does not intend to consider a compounder to have exceeded the limited quantity condition of the FDCA if the compounder holds no more than a 30-day supply of a particular compounded drug product and the amount is based on the number of valid prescriptions for identified individual patients the compounder has received in a 30-day period over the past year. FDA also discusses what is considered a patient-specific prescription in light of some state rules allowing prescriptions to be written without individual patient names.
Hospital and Health System Compounding Under the FDCA. Pharmacies within a hospital or stand-alone pharmacies that are part of a health system provide compounded drugs for administration within the hospital or health system. Because the FDCA does not distinguish between stand-alone pharmacies and pharmacies in hospitals and health systems, FDA states Section 503A applies to pharmacists, pharmacies, and physicians that compound drugs within a hospital or health system that is not registered as an outsourcing facility. FDA advises that it does not intend to take enforcement action if a hospital pharmacy distributes compounded drug products without first receiving a patient-specific prescription or order, provided that: (i) the drug products are distributed only to health care facilities that are owned and controlled by the same entity that owns and controls the hospital pharmacy and that are located within a one-mile radius of the compounding pharmacy; (ii) the drug products are administered only within the health care facilities to patients within the health care facilities, pursuant to a patient-specific prescription or order; and (iii) the drugs are compounded in accordance with all other provisions of Section 503A and relevant provisions of the FDCA. Note that FDA's allowance does not extend to a drug dispensed to a patient for use outside the hospital.
Facility Definition Under Section 503B of the FDCA. Section 503B defines an "outsourcing facility" as "a facility at one geographic location or address." The draft guidance states that FDA interprets this to mean a business or other entity under one management, direct or indirect, engaged in human compounding at a geographic location or street address. In addition, it considers all activities, equipment, appurtenances, and materials part of such a facility if they are related to human drug compounding under the supervision of the facility's management at the same street address, or in the same building, or in buildings in close proximity to one another. FDA states that the outsourcing requirements of Section 503B cannot be avoided by segregating or subdividing compounding within an outsourcing facility.
Notices of the draft guidance documents were published in the April 18, 2016, Federal Register. (See the specific notices for the Prescription Requirement, Hospital/Health System Compounding, and Facility Definition draft guidance documents.) FDA is requesting comments on the draft guidance documents by July 18, 2016.
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