A PCAC meeting with close to 2000 comments on the public docket and a recommendation that goes against FDA staff recommendations! What’s next? Following the PCAC meeting, FDA may accelerate the timeline or use enforcement discretion, such as Category I as a bridge since the rulemaking process could take 12-24 months. What is certain is more peptides will be able to be compounded and the rules for compounding peptides are about to become a whole lot clearer. With peptides, there is no FDA 503e shortage list to confound those who invest in compounding peptides.
Certain groups such as the National Association of Boards of Pharmacy (NABP) are pushing for more guardrails on peptide compounding. A Memorandum of Understanding (MOU) between the FDA and states is on the horizon. Although unsuccessfully proposed twice with FDA sued by compounding pharmacies, FDA has said they intend to pursue the MOU via a Notice & Comment rulemaking. Some provisions of the MOU may include inter alia monitoring of interstate distribution of compounded drugs via volume reporting, mandatory adverse drug event reporting, clear enforcement channels between FDA and Boards of Pharmacy, traceability via DSCSA serialization, as well as bulk API and product verification. Other guardrails may be in the form of a USP monograph for some of the peptides which could provide standardization. However, this would need to be an exception because FDA approval is usually required before USP considers any ingredient for a monograph. That could easily change.
No one really knows what the future will hold; something better may come along or side effects could be found or exponential demand could continue. Growth is expected with the development of oral delivery via nanotechnology or absorption promoters, novel formulations and intellectual property work arounds such as the 505(b)(2) regulatory pathway. A company that files a 505(b)(2) could potentially gain three years of market exclusivity, even without composition patent protection. Peptide clinical trials are occurring (clinicaltrials.gov) but for now FDA approval is unlikely before 2030 and the compounding pathway is the primary access route.
Compounders are urged to proceed cautiously and seek legal/regulatory advice while awaiting FDA’s forthcoming decisions and positioning themselves for more peptide compounding.
