On July 12, 2016, the U.S. Food and Drug Administration (FDA) announced a change in the procedure it will utilize for inspections of compounding firms that are seeking to compound human drugs in accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA). Effective August 1, 2016, FDA investigators performing inspection of compounding facilities now will make a preliminary assessment regarding a compounder’s compliance with conditions of Section 503A as a licensed traditional compounding pharmacy. The inspectors will not include observations that represent deviations solely from CGMP requirements unless the investigators’ assessment is that the compound drugs do not qualify for the exemptions under Section 503A. The FDA’s reasoning behind this shift in policy is founded in Section 503A of the FDCA, which describes the conditions for human drug compounds, which if met, will exempt the compounding pharmacy from compliance with certain sections of the FDCA, including CGMP requirements. Thus, if the inspectors make the initial determination that a facility is operating in accordance with Section 503A (namely, that it is compounding pursuant to patient-specific prescriptions and operating otherwise in compliance with the applicable State Board of Pharmacy requirements), the FDA inspectors will refrain from noting CGMP deviations in a final inspection report.
However, even though drug products compounded in accordance with the conditions of Section 503A are exempt from certain requirements in the FDCA, including CGMP, they still remain subject to all other provisions of the FDCA that apply to all drug establishments, including, but not limited to, the prohibition on preparing, packing, or holding drugs under insanitary conditions. The FDA has made clear that they will still inspect traditional Section 503A compounding pharmacies for the existence of “insanitary conditions,” and will continue to include Form 483 observations when insanitary conditions are noted. Thus, this Notice does not exempt Section 503A compounding pharmacies from FDA inspection altogether.
In the event the FDA’s more thorough post-inspection review differs from the FDA investigators’ preliminary assessment and reveals that a compounder has failed to produce drugs in accordance with the conditions of Section 503A, the FDA intends to consider citing the compounder for CGMP violations. Thus for this reason, notwithstanding the fact that compounding pharmacies may not ultimately be cited for CGMP violations in a final agency report, the FDA will continue to inspect even Section 503A pharmacies against the CGMP rubric (again, in the event the determination of non-compliance with Section 503A is ultimately made).
In sum, in order to avoid unnecessary regulatory action, such as a warning letter, traditional compounding pharmacies are advised to (1) maintain compliance with the requirements of Section 503A to avoid being held to CGMP standards (among other requirements); and (2) maintain their compounding area and ensure the components they utilize for their human drug products are prepared, packed, or held under sanitary conditions.
The attorneys at Frier Levitt have experience in advising pharmacies on issues related to compliance with State and Federal pharmacy laws and regulations. We have represented compounders going through FDA inspections, and have assisted traditional licensed compounding pharmacies remain compliant with applicable USP standards. The attorneys at Frier Levitt can review and update your pharmacy’s policies and procedures to ensure compliance with these standards, and can assist with State or Federal regulatory inspections. If you need assistance, contact us today to speak to an attorney.
