FDA Releases “Notice” Advising of a Change in Inspections of Pharmacies Compounding Drug Products within FDCA Section 503A: Let’s Watch What Happens Next….

July 20, 2016

By Karla L. Palmer –

FDA posted a “Notice” on July 12, 2016, advising compounding pharmacies regulated under Section 503A that, effective August 1, 2016, FDA is changing inspection procedures for Section 503A pharmacies (see Notice here). FDA announced that it now will make a “preliminary assessment” whether compounders are compounding in accordance with the conditions in Section 503A.  If a FDA Form 483 is issued upon completion of the inspection, then FDA will not include those observations including a violation of FDA’s current good manufacturing practices (“cGMP”), unless (importantly), based on the investigator’s preliminary assessment, the pharmacy is operation outside the scope of Section 503A.  In past inspections, FDA has more often than not inspected compounding pharmacies (deemed a “producer of sterile drug products”) in accordance with a cGMP standard used for drug manufacturers and from which (lawful) compounders are statutorily exempt.  FDA has at times held a compounder to this standard because, for example, it (unlawfully) compounded preparations for office use, or not solely for individually identified patients.  For other compounders, FDA determined that they were not exempt from cGMP for the circular reason that they may have engaged in compounding under allegedly insanitary or filthy conditions in violation of Section FDCA Sections 501(a)(1) and (a)(2) — based on an inspection conducted pursuant to cGMP.  For still other compounders, FDA would not articulate at the exit interview exactly what standard – USP<795>, USP<797>, cGMP or any other standard – it had relied on during the pharmacy inspection. 

FDA states that it is changing its inspection procedures based on “stakeholder input.”  That “input” could be the position set forth in the 2017 House Agriculture Appropriations Committee Report (April 2016) related to inspections.  The statement directed FDA not to inspect state licensed pharmacies under cGMP.  The text of that directive is as follows: 

Drug Compounding Inspections.—The Committee understands that the FDA is interpreting provisions of Section 503A of the FDCA to inspect state-licensed compounding pharmacies under current Good Manufacturing Practices (cGMPs) instead of under the standards contained in the United States Pharmacopeial Convention (USP) for sterile and non-sterile pharmaceutical compounding or other applicable pharmacy inspection standards adopted by state law or regulation. The Committee reminds the FDA that compounding pharmacies are not drug manufacturers, but rather, are state licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within their states. Compounding pharmacies are more appropriately inspected using USP standards or other pharmacy inspection standards adopted by state law or regulation in the state in which a pharmacy is licensed.          

Notwithstanding this directive,  FDA states at page 2 of the Notice that, “Importantly,” drug compounders remain subject to all other FDCA provisions “that apply to conventional drug manufacturers.  Because FDA “does not contain an exemption from the prohibition on insanitary conditions,” investigators will continue to include observations related to these conditions without regard to the preliminary assessment of the firm’s “status” under Section 503A.  But what remains unclear from FDA’s Notice is whether FDA’s “preliminary assessment” of “insanitary conditions” itself will be pursuant to cGMP, USP, or standards otherwise applicable to a compounding pharmacy.  It is similarly unclear exactly what standard, other than cGMP, FDA investigators will use for pharmacy inspections generally after August 1.  For example, will FDA hold pharmacies to certain state board of pharmacy requirements, USP<795> and USP<797>, or another inspection standard?  We are curiously awaiting the wave of FDA Form 483 observations issued after August 1, 2016 to see whether the changed inspection standard actually results in changes in FDA’s Form 483 observations issued to Section 503A pharmacies.