Statement of APC's position on the statutory and regulatory framework for pharmacy compounding

We advocate on behalf of patients whose health depends on and whose lives are enhanced by compounded medications. On behalf of those patients, as well as our members who prepare their medications, we advocate for a strong, science-based, practical regulatory framework that preserves the essential role of pure-ingredient pharmacy compounding in the healthcare system—as enshrined in the federal Food, Drug & Cosmetic Act and the Drug Quality & Security Act. We often find ourselves opposing FDA regulatory efforts that do not directly serve patient interests, including those that do not preserve the role of pharmacy compounding as defined in statute. But that doesn’t mean we’re opposed to regulation. Quite the contrary. The basis for our opposition to specific FDA actions is most often FDA efforts to exceed its mandate from Congress, sometimes even inappropriately manipulating the process in order to get the research or results it wants. Evidence of FDA’s overreach includes:

We defend patient access to compounded preparations and the right of pharmacy compounders to prepare medications from pure ingredients under the law. FDA’s ongoing efforts to require that both human and animal compounding begin with manufactured drugs rather than pure active pharmaceutical ingredient sourced from FDA-registered providers run counter to the law, the practice of medicine, and clearly identified patient need, not to mention important practical considerations regarding dosage strength and affordability.

We note and support the right of prescribers to determine the proper course of treatment or therapy for their patients, including, when appropriate, the prescribing of compounded medications. Further, we honor and uphold the triad relationship between prescriber, pharmacist, and patient in determining a patient’s care, acknowledging that the prescriber relies on his or her judgment in prescribing care and it is not the compounder’s role to make that determination. FDA has no mandate in law to infringe upon via its regulations a prescriber’s medical judgment — or indeed, the prescriber’s right and ability to practice medicine.

We affirm and advocate for the continued regulation of pharmacy dispensing—that is, the preparation of compounded medications pursuant to a patient-specific prescription—by state boards of pharmacy, not by FDA. Likewise, we support FDA oversight of pharmacy distributions—that is, the preparation and distribution of compounded medications to hospitals, clinics, and physician offices without a prescription—as well as the registration of 503B outsourcing facilities with FDA. That distinction between dispensing and distribution is rooted in federal law, as well as pharmacy license law in many states, and we assert that FDA does not have the authority to conflate the definitions of those terms via regulation, nor to assert itself in in the traditional practice of patient-specific dispensing, long the purview of state boards of pharmacy.

We recognize, value and defend the requirement that 503A compounding pharmacies may only dispense compounded medications for humans pursuant to a patient-specific prescription. (We also support proper office-use compounding for animal patients.) We also recognize that the path FDA created in 2020, under temporary guidance during the pandemic, for 503As to source certain shortage COVID medications to hospitals when those preparations are unavailable from 503Bs was and is much needed, and should be expanded, under the same very stringent guardrails FDA mandates, to allow other shortage drugs to be prepared and distributed to medical offices to meet patient need. Why? Because economic models under which 503Bs can prepare many shortage drugs for a short duration of time simply don’t and won’t exist, resulting in patients unable to access essential medications that are in shortage.

We support the role of 503B facilities that adhere to cGMP to prepare and distribute compounded medications to hospitals, clinics and physician practices without a patient-specific prescription; we also support 503B outsourcing facilities’ ability to sell compounded medications to traditional 503A compounding pharmacies for dispensing to patients, pursuant to a prescription.. As stated above, we also note that economic models under which 503Bs can prepare many drugs simply don’t yet exist. FDA has done little to incentivize a stable 503B marketplace — with economic incentives for preparing many much-utilized compounded preparations for which there is no workable economic model — and in fact has disincentivized it via their continual foot-dragging in approving a 503B bulks list of substances that may be compounded by 503Bs.

We support the compounding of drug substances for which there is an applicable USP monograph, including dietary supplements. Despite the fact that dietary supplements may be purchased at any local health food store without a prescription, FDA continues to draw an arbitrary distinction between dietary supplement monographs and drug monographs and prohibits compounding with them (even when they are sourced from FDA-registered manufacturers) — a distinction not made in the FD&C Act and DQSA and never mentioned in congressional hearings.

We support without condition FDA’s Guidance for Industry document on preventing insanitary conditions in compounding pharmacies and facilities. Full compliance on this matter is absolutely essential for patient safety. Equally essential is that FDA and state inspectors be properly trained and knowledgeable of the appertaining regulations that distinguish compliance by 503A pharmacies from that of 503B outsourcing facilities. Based on their carve-out in the FD&C Act and DQSA, it is unacceptable that 503A pharmacies be held to the cGMP standard.

We acknowledge the need and opportunity to strengthen adverse event reporting in pharmacy compounding and would welcome a good-faith collaboration with state boards of pharmacy and FDA to create a proper framework. However, FDA’s ongoing assertion that any unexpected patient reaction to a compounded preparation should be treated as a serious adverse event is simply unacceptable.

Moreover, we’d welcome a conversation—a real conversation—with FDA and state boards about stronger labeling requirements for compounded medications.. Any such conversation would need to start with acknowledgement that the variety of formulations in compounding make complete standardization difficult if not impossible. Still, we’d like to think that middle ground could be found.

We also support and recommend the accreditation of compounding pharmacies by entities such as the Accreditation Commission for Health Care as a means of elevating compliance and professionalism, and we further recommend that FDA consider how accreditation may help address some of the agency’s ongoing concerns about regulatory compliance.