FDA Adds Several Peptides to Category 2 Bulks List, Restricting Them From Compounding

On September 29, 2023, updates were made to the list of bulk drug substances nominated for use under Section 503A. While GHK-Cu (with certain limitations) and L-Theanine have now been included on to the Category 1 bulks list, various peptides were added to the Category 2 bulk drug substance list (those that raise significant safety concerns).

Several Substances Get Placed on the Category 2 Bulks List

The following substances were added to Category 2 because FDA claimed to identify significant safety risks:

  • AOD 9604

  • BPC-157

  • Cathelicidin LL-37

  • CJC-1295

  • Dihexa Acetate

  • Emideltide (DSIP)

  • Epitalon

  • GHK-Cu (for injectable routes of administration)

  • Ibutamoren Mesylate

  • Ipamorelin Acetate

  • Kisspeptin-10

  • KPV

  • Melanotan II

  • Mechano Growth Factor, Pegylated (PEG-MGF)

  • MOTs-C

  • Selank Acetate (TP-7)

  • Semax (heptapeptide)

  • Thymosin Alpha-1 (Ta1)

  • Thymosin Beta-4, Fragment (LKKTETQ)

Compounding Industry Group Initial Response

In early October, Scott Brunner from the Alliance for Pharmacy Compounding (APC) commented on the updates, particularly noting the addition of certain peptides to Category 2. He mentioned,

"There hasn't been a notable opposition from our members in challenging these items, possibly because they don't meet the criteria under 503A."

According to Section 503A of the Food, Drug & Cosmetic Act, an eligible bulk drug substance for compounding must be a component of an FDA-approved drug, must have a USP or NF monograph, or must appear on the FDA’s 503A Bulks List or Interim Bulks List Category 1. The peptides now categorized under Category 2 have not met these specified criteria.

Prescribers Attempt to Fight Back

In response to the recent changes to the bulks lists, some prescribers began encouraging their patients to sign a petition to encourage legislators to make a change and allow some of these substances to be able to be compounded. Their goal is to obtain 10,000 supporters.

Compounders Question FDA’s Rationale and Evidence Pointing to Safety Concerns

On October 27, 2023, APC urged FDA via letter addressed to Gail Bormel, Director of the FDA's Office of Compounding Quality and Compliance, for transparency regarding the recent inclusion of substances into Category 2.

APC is seeking clarification on the decision-making process employed by the FDA in categorizing new substances into Category 2. While the agency has cited "significant safety risks" as the rationale behind this categorization, it has not divulged the specific methodology or details pertaining to the identified risks.

APC emphasizes the need for more comprehensive information about the FDA's substance-specific safety concerns. Such details, according to the letter, would aid organizations like APC in educating pharmacists, technicians, and other stakeholders about the reasons behind adding substances to Category 2 and the inherent risks perceived by the agency in compounding with them.

Is There a Path Where Peptides Can Appear on Category 1 or the Final Bulks List?

The affected peptides aren't permanently confined to Category 2. To potentially move them into Category 1 or final Bulks List status, the most effective approach is to present a persuasive case for their clinical efficacy and safety to the Pharmacy Compounding Advisory Committee (PCAC) and submit it to the FDA. Building such a case necessitates rigorous scientific backing, credible research, and robust patient outcome data.

Does Your Facility Produce Quality Preparations?

If you’re ready to bring quality to the center of your compounding operations, consultants at Restore Health Consulting LLC can help you design a robust quality management system to promote patient safety and regulatory compliance.

Amy Summers