FDA may revisit peptide compounding eligibility at July meeting
WHAT HAPPENED — According to a Federal Register notice posted April 15, the FDA will hold a Pharmacy Compounding Advisory Committee meeting on July 23–24, 2026 to evaluate whether to add seven peptides — including Emideltide (DSIP), Semax, and Epitalon-related substances — back to the 503A bulks list. A second meeting is expected before February 2027 to review additional substances.
WHY IT MATTERS — This could be a meaningful signal for compounders. If even some of these peptides move back toward Category 1 eligibility, it may expand what pharmacies can legally compound and reduce some of the demand currently flowing to non-pharmacy channels. It may also give a better sense of how aggressively FDA plans to enforce around peptides more broadly.
WHAT TO DO — Consider submitting a public comment ahead of the July meeting or coordinating through APC. If you’re currently compounding peptides, it’s worth mapping which ones you use against the list under review so you’re prepared to adjust based on the outcome.
Source: Federal Register; STAT
FDA clarifies “essentially a copy” standard for GLP-1 compounding
WHAT HAPPENED — In an April 1 communication, FDA clarified that compounded GLP-1 products using the same API, strength, and route of administration as drugs like Ozempic, Wegovy, Mounjaro, and Zepbound may be considered “essentially a copy” unless a prescriber documents a patient-specific clinical difference. The agency also indicated it does not intend to take enforcement action against 503A pharmacies dispensing four or fewer prescriptions per month of such products.
WHY IT MATTERS — This guidance likely narrows the flexibility many pharmacies have relied on, including common additive approaches like B12 combinations. It also gives regulators and manufacturers a clearer framework to evaluate volume and intent. If GLP-1s represent a meaningful portion of your compounding volume, this is worth paying close attention to.
WHAT TO DO — Pull your GLP-1 dispensing data from the past 60–90 days and review volume by formulation. For higher-volume items, make sure there is clear, patient-specific documentation where appropriate, and consider reviewing your approach with legal or compliance counsel.
Source: FDA; Foley & Lardner
NCPA fly-in pushes for broader PBM reform
WHAT HAPPENED — Per NCPA updates, independent pharmacy owners met with Congressional offices April 15–16 following recent Part D reforms, advocating for similar changes across Medicaid, TRICARE, and the Federal Employee Health Benefits Program.
WHY IT MATTERS — While Part D reforms are set to roll out over the next few years, a large portion of prescription volume still flows through programs where reimbursement pressure remains unchanged. Future reform efforts will likely determine how much of the expected margin improvement actually shows up at the pharmacy level.
WHAT TO DO — If this impacts your business, consider reaching out to your local representatives. Even a short note referencing current reimbursement challenges can be helpful when these discussions are active.
Source: NCPA
Indiana Board rejects proposed settlement in diversion case
WHAT HAPPENED — Reported by Indiana Capital Chronicle, the Indiana Board of Pharmacy rejected a proposed settlement tied to a diversion case involving over $120K in controlled substances. The case will now move to a full hearing.
WHY IT MATTERS — This may signal that boards are taking a stricter stance on diversion cases, particularly where oversight gaps are identified. The board also referenced pandemic-era disruptions, which could be relevant for pharmacies that had looser controls during that period.
WHAT TO DO — It’s a good time to revisit controlled substance processes — especially reconciliation, documentation, and oversight — and make sure everything would hold up under review.
Source: Indiana Capital Chronicle
DEA issues Immediate Suspension Order to Tennessee pharmacy
WHAT HAPPENED — According to a DEA press release, the agency issued an Immediate Suspension Order (ISO) to a retail pharmacy in Chattanooga, TN on April 6, removing its authority to handle controlled substances pending further proceedings.
WHY IT MATTERS — ISOs are still relatively uncommon for standard retail operations, but they highlight how quickly enforcement can escalate when multiple compliance issues are identified. These cases often involve both state board and federal coordination.
WHAT TO DO — Review recent PMP checks, documentation practices, and red-flag handling — especially for new patients or higher-risk prescriptions. Make sure your workflow consistently captures this information.
Source: DEA
California bill could add state-level restrictions on GLP-1 compounding
WHAT HAPPENED — Per APC updates, California’s AB 1990 is moving through committee and would introduce additional restrictions on GLP-1 compounding beyond current federal guidance. Similar legislation has been introduced in several other states.
WHY IT MATTERS — If passed, this could create a patchwork of state-level requirements layered on top of FDA guidance, increasing compliance complexity — especially for pharmacies shipping across state lines.
WHAT TO DO — If you serve patients in California or other active states, keep an eye on these bills and consider engaging through your state association or APC.
Source: APC
Independent pharmacy closures gaining national attention
WHAT HAPPENED — A recent InvestigateTV report highlighted continued closures of independent pharmacies, citing research that a significant share have shut down over the past decade, with PBM practices frequently identified as a major driver.
WHY IT MATTERS — Increased media attention tends to accelerate policy discussions, especially in an election cycle. This could lead to more aggressive legislative or regulatory action at the state level.
WHAT TO DO — No immediate action, but worth monitoring. If legislation is active in your state, sharing real reimbursement data with your association can help shape the conversation.
Source: InvestigateTV
CVS completes acquisition of select Rite Aid/Bartell assets
WHAT HAPPENED — According to AJMC, CVS has completed its acquisition of select Rite Aid and Bartell locations, along with prescription files from hundreds of closed stores across multiple states.
WHY IT MATTERS — While files are transferring to CVS, patients are not locked in — and many are still choosing where to go next. This creates a short window where independents can still capture new patients.
WHAT TO DO — If you’re near recently closed locations, consider a focused new-patient push over the next 30–60 days (local outreach, Google presence, direct mail, etc.).
Source: AJMC
CMS moves forward with next round of Medicare price negotiations
WHAT HAPPENED — CMS announced that manufacturers for the next round of Medicare drug price negotiations have been selected, with pricing expected to take effect in 2028. This follows earlier announcements impacting drugs like Ozempic and Wegovy starting in 2027.
WHY IT MATTERS — These changes will likely impact reimbursement structure and margins, particularly for high-volume medications. How PBMs handle these changes will matter.
WHAT TO DO — If you haven’t already, consider asking your PBMs how they plan to handle reimbursement for these drugs under the new framework.
Source: CMS
Final Note
This newsletter is for informational purposes only and does not constitute legal or regulatory advice.