Regulatory Tracker
Monitoring FDA, HHS, and state-level regulatory changes affecting peptide access and compounding.
March 5, 2025
Senate Hearing on Compounding Pharmacy Regulation
Senate HELP Committee examines compounding pharmacy oversight framework, particularly for GLP-1 medications.
Source: Senate HELP Committee →February 10, 2025
State Pharmacy Boards Increase Peptide Compounding Oversight
Texas, Florida, and California pharmacy boards begin enhanced inspections of compounding pharmacies dispensing peptides.
Source: NABP →January 20, 2025
HHS Signals Review of Peptide Compounding Framework
New HHS leadership indicates potential changes to how compounded peptides are regulated, with possible expanded access for certain compounds.
Source: HHS →December 5, 2024
Novo Nordisk Sues Compounders Over Semaglutide
Pharmaceutical manufacturer files trademark and patent infringement suits against compounding pharmacies producing semaglutide.
Source: Reuters Legal →November 15, 2024
Federal RICO Suit Targets Telehealth-Compounding Pipeline
A class action alleges coordinated fraud in how certain telehealth platforms and pharmacies have marketed and prescribed compounded GLP-1 medications.
Source: Reuters Legal →October 2, 2024
FDA Removes Semaglutide from Drug Shortage List
The FDA has declared the semaglutide shortage resolved, removing the legal basis for most compounding of the medication.
Source: FDA →September 20, 2024
FDA Reviews BPC-157 Bulk Drug Substance Category
Pharmacy Compounding Advisory Committee reviews BPC-157 for potential reclassification under bulk drug substance categories.
Source: FDA PCAC →August 15, 2024
FDA Warning Letters to Online Peptide Vendors
Multiple warning letters issued to companies selling peptides as research chemicals deemed to be unapproved drugs marketed for human use.
Source: FDA →