News Roundup this Week

• FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize: The FDA reiterated on Feb. 11, 2025 that it will maintain enforcement discretion for compounding tirzepatide injections (the active ingredient in Mounjaro/Zepbound) for now. This means the agency does not intend to take action against state-licensed 503A pharmacies compounding tirzepatide until February 18, 2025 (and 503B outsourcing facilities until March 19, 2025), or until a pending federal court ruling is issued, whichever is later.
  

• Heightened Oversight of Compounders: In response to the compounding boom around high-demand drugs, regulators and payers are stepping up oversight. Observers note that 503A compounding pharmacies can expect more inspections by state Boards of Pharmacy and audits by pharmacy benefit managers (PBMs) due to the rising volume of compounded GLP-1 prescriptions​. This trend suggests state regulators are keeping a close eye on quality and compliance (e.g. proper prescriptions and sterile practices), while PBMs scrutinize reimbursement claims for compounded drugs. Compounding pharmacies may need to bolster their compliance efforts as both government and private entities increase scrutiny in this area​.
  

• Manufacturer Lawsuits Against Compounders – Novo Nordisk Loses in Court: Tension between drug manufacturers and compounding pharmacies also played out in recent court decisions. In a February 2025 ruling, a federal judge dismissed a lawsuit by Novo Nordisk (maker of Ozempic/Wegovy, containing semaglutide) against a compounding pharmacy (Wells Pharmacy Network)​. The judge concluded that Novo Nordisk lacks standing to enforce the Food, Drug and Cosmetic Act (FDCA) – essentially only the FDA can take action against compounders for FDCA violations, not private companies​. This marks the second legal defeat for Novo Nordisk in about a month on this issue​. In both cases, courts have reminded manufacturers that they cannot use litigation to police compounders by claiming violations of the FDA’s rules. These outcomes are victories for compounding pharmacies, reinforcing that enforcement of compounding restrictions is left to regulators (FDA and state boards) rather than competitor drug companies.

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