Key Points

• FDA action remains pending after the Pharmacy Compounding Advisory Committee recommended six of seven peptide bulk drug substances for inclusion on the 503A bulks list.
• Compounding pharmacies should proceed cautiously while awaiting formal FDA guidance or rulemaking on compounded peptide drugs.
• Prescribers, clinics and patients should verify compliance by confirming pharmacy licensure, accreditation, FDA inspection history and applicable standards of care.

Following the July 23 and 24 meetings of the FDA’s Pharmacy Compounding Advisory Committee (PCAC) on the subject of compounded peptide drugs, compounding pharmacies and other healthcare stakeholders should proceed carefully while awaiting formal FDA action.

While the meeting addressed key questions about the compounding of certain peptide substances it also ushered in a period of regulatory uncertainty.

Here is a rundown of what’s next and some key considerations for compounding pharmacies, prescribers, clinics and patients in the interim.

The Ball Is in the FDA’s Court

Following the PCAC meeting, the next moves belong to the FDA. PCAC voted to recommend six out of seven bulk drug substances it considered, but that recommendation is simply a suggestion. Only the FDA has the legal authority to initiate rulemaking, and FDA staff previously did not recommend any product that PCAC considered.

The agency could announce enforcement discretion measures such as placement of certain substances on Category 1 of the 503A or 503B bulks lists prior to initiating formal proposed rulemaking. Industry stakeholders should monitor FDA announcements closely, as any policy shifts could come with limited advance notice.

It is important to note that the PCAC hearing pertained specifically to Section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 353a), which governs compounding by state-licensed pharmacies. However, the policy considerations raised during the hearing have significant implications for Section 503B outsourcing facilities as well, particularly with respect to the availability of bulk drug substances for compounding.

Under Section 503A, a state-licensed pharmacy may compound drug products using bulk drug substances only if one of three conditions are met:

1. They are components of FDA-approved drugs.
2. The bulk drug substances comply with the standards of an applicable USP or NF monograph (if one exists).
3. They appear on a list developed by the Secretary through regulation.

The substances at issue are not currently components of FDA-approved drugs and do not have USP monographs. The purpose of the PCAC hearing was for PCAC to recommend whether FDA should place certain bulk drug substances on the 503A bulks list which will directly affect whether pharmacies may lawfully compound them under Section 503A.

Pharmacies Should Tread Lightly

Compounding pharmacies should proceed cautiously during this interim period. Until FDA provides definitive guidance or takes formal rulemaking action, pharmacies face risk if they expand or initiate compounding activities based on assumptions about FDA’s forthcoming decisions.

State Law Considerations

State pharmacy laws and regulations remain in effect and may differ from or impose additional requirements beyond the federal framework. Pharmacies must ensure compliance at both the state and federal levels. Pharmacies should consult with counsel regarding the specific regulatory requirements in each state in which they operate.

Practical Considerations for Prescribers, Clinics and Patients

Prescribers, clinics, and patients who wish to obtain compounded peptide products should exercise due diligence when selecting a compounding pharmacy. The following steps can help ensure that a pharmacy is operating in compliance with applicable law and quality standards:

• Verify that the pharmacy is licensed in the state into which the prescription is being dispensed. State licensure is a baseline requirement, and pharmacies dispensing across state lines must hold the appropriate licenses in each applicable jurisdiction.
• Look for relevant accreditations. Accreditation by recognized organizations (such as Pharmacy Compounding Accreditation Board (PCAB), Accreditation Commission for Health Care (ACHC), National Association of Boards of Pharmacy (NABP) or Legit Scripts) can provide additional assurance that the pharmacy adheres to rigorous quality and safety standards beyond minimum regulatory requirements.
• Check whether the pharmacy has been inspected by FDA. FDA’s inspection database is publicly available and can be accessed at this link. A history of FDA inspection, and the outcomes of those inspections, can provide insight into a pharmacy’s compliance posture.
• Ensure adherence to the applicable standard of care. Prescribers should confirm that their prescribing of compounded peptide products is consistent with the standard of care in their jurisdiction, including appropriate patient evaluation, informed consent, and clinical monitoring.

Practical Guidance for Pharmacies Wishing to Compound Peptides

Pharmacies that wish to compound peptide products during this period of regulatory uncertainty should take all the following steps:

• Confirm that an applicable compounding pathway exists under federal law (e.g., Section 503A for traditional compounding pharmacies or Section 503B for outsourcing facilities)
• Confirm that an applicable compounding pathway exists under the relevant state law and regulations.
• Source active pharmaceutical ingredients (API) only from FDA-registered facilities that comply with current good manufacturing practice (cGMP) requirements.
• Comply with applicable compounding quality standards, such as USP <795> (for non-sterile compounding) or USP <797> (for sterile compounding) and current good manufacturing practices (cGMP) for outsourcing facilities.

If you have questions about peptides, the drug supply chain, or compounding generally can contact the author, Marc Wagner, at mwagner@foxrothschild.com or another member of the firm’s Health Law team.

This information is intended to inform firm clients and friends about legal developments, including the decisions of courts and administrative bodies. Nothing in this alert should be construed as legal advice or a legal opinion. Readers should not act upon the information contained in this alert without seeking the advice of legal counsel. Views expressed are those of the authors and not necessarily this law firm or its clients.