Pharmacy Compounding Regulation

FDA cited Empower Pharmacy in warning letter #738238, after a November 3 to November 14, 2025 inspection. FDA said the pharmacy compounded, regularly or in inordinate amounts, drug products that were essentially copies of commercially available drug products, so the products did not qualify for the exemptions in section 503A of the Federal Food, Drug, and Cosmetic Act. The products at issue were tirzepatide with niacinamide, in 17/2 mg/mL and 8/2 mg/mL strengths, and semaglutide with cyanocobalamin, 5/0.5 mg/mL. FDA described large monthly order volumes for each from July through October 2025. The specific quantities are redacted in the public letter.

Under section 503A, a compounded drug is not essentially a copy when a change is made for an identified individual patient that produces a significant difference for that patient, as determined by the prescribing practitioner. The letter is notable for how closely FDA examined that determination. FDA found some orders and prescriptions with no prescriber determination of significant difference at all. Others had significant-difference statements that appeared verbatim across many records, which FDA said suggested the statements may have been pre-generated. FDA also cautioned against generating prescriptions “through means that undermine the individualized nature of a prescriber’s clinical judgment.” Its example was third-party technology platforms that give prescribers pre-selected menu options for a statement of significant difference. FDA also stated that “the volume of products you are producing suggests that differences between products you are compounding and the FDA-approved products are pretextual.”

Because FDA concluded the products did not meet the conditions of section 503A, the letter treats them in three ways:

• as unapproved new drugs under section 505(a);

• as misbranded for lacking adequate directions for use under section 502(f)(1);

• as subject to current good manufacturing practice requirements.

FDA separately cited insanitary conditions under section 501(a)(2)(A). The findings included smoke studies in the ISO 5 area that were not performed under dynamic conditions, and media fills that did not simulate the most challenging conditions. FDA also questioned the documentation the firm submitted in response to the Form FDA 483 issued November 14, 2025. As in the Boothwyn letter, FDA stated that the insanitary-conditions provision applies whether or not a compounded drug meets the conditions of section 503A.

For 503A pharmacies, the letter does not create a new rule or a categorical ban on patient-specific compounding of semaglutide or tirzepatide. It also does not say that adding an ingredient such as a vitamin can never produce a clinically significant difference for a patient. It does signal that a different formulation, by itself, may not establish the individualized prescriber determination that section 503A requires. Pharmacies should review their practices closely in three situations:

• the same formulation is dispensed to large numbers of patients;

• identical or nearly identical significant-difference statements recur across prescriptions;

• prescribing or telehealth platforms generate or pre-populate the reason a compounded product is significantly different for a patient.

Source: Warning Letter, Empower Clinic Services, LLC dba Empower Pharmacy, #738238, September 18, 2026

Apollo Care initiated a nationwide recall of multiple lots of compounded semaglutide and semaglutide with glycine after particulate matter was identified in product vials. FDA enforcement records list 11 Class II recall entries, D-0747-2026 through D-0757-2026, covering more than 162,000 multi-dose vials. The stated reason for the recalls was particulate matter identified as nylon/polyamide and proteinaceous material described as silk-type material.

The recall followed an FDA inspection conducted July 13 through July 28, 2026. In the Form FDA 483 issued at the close of that inspection, investigators reported that a review of retain samples identified approximately 59 vials, across eight lots of semaglutide and semaglutide with glycine, containing white particles of varying size and quantity, and stated that the firm had not previously been aware of them. FDA subsequently made the Form 483 public. A Form 483 documents investigators’ observations and does not constitute a final agency determination that a firm violated federal law.

Four of the seven observations on the July 2026 Form FDA 483 are designated as repeat observations, including findings on aseptic process validation, investigation of discrepancies and batch failures, control of aseptic processing areas, and facility construction. That designation is notable because Apollo Care had received an FDA warning letter dated February 2, 2026 following a March 10 to March 27, 2025 inspection, in which FDA cited serious deficiencies in the facility’s sterile-production practices. The warning letter also noted that Apollo Care voluntarily recalled a compounded fentanyl and ropivacaine epidural product in April 2025 because of a lack of sterility assurance.

The July 2026 Form FDA 483 also includes a separate observation concerning Apollo Care’s use of bulk semaglutide and tirzepatide. FDA investigators stated that the facility compounded drug products using those bulk drug substances when the corresponding drug products were not on FDA’s drug shortage list and the bulk substances did not appear on FDA’s list of bulk drug substances for which FDA has identified a clinical need for use by outsourcing facilities. This is an inspectional observation specific to Apollo Care’s operations and should not be read as a complete statement of the law governing every circumstance in which a compounded GLP-1 product may be prepared.

Pharmacies and other healthcare providers evaluating potentially affected Apollo Care products should consult the applicable FDA recall records for product, lot, and expiration information.

Sources: Form FDA 483, Apollo Care, LLC, inspection July 13 to 28, 2026; Warning Letter, Apollo Care, LLC, #715955, February 2, 2026; FDA Enforcement Report database

F.H. Investments, Inc., doing business as Asteria Health, voluntarily recalled specified lots of compounded hormone pellets because of the potential presence of metal particulate matter. The recall covered products shipped between May 20, 2025 and January 19, 2026 and was conducted with FDA’s knowledge.

FDA classified the affected recalls as Class II on February 11, 2026. The recall covered estradiol sterile pellets ranging from 6 mg to 37.5 mg, totaling more than 118,000 pellets, as part of a broader recall that also included testosterone and combination hormone-pellet products.

The recall followed an FDA inspection conducted December 5 through December 19, 2025. The resulting Form FDA 483 documented recurring metallic and foreign-material contamination events tied to pellet presses and microcappers between May and November 2025, each resulting in rejected batches, and found that the firm’s investigations of those events did not analyze contaminant types or sources or characterize contaminant properties. Investigators also cited absence of process validation, absence of sterilization validation, and failure to document metal-detection results in batch records. As with all Form FDA 483 observations, these inspectional observations do not represent a final FDA determination of regulatory violations.

Sources: Form FDA 483, F.H. Investments, Inc. (dba Asteria Health), inspection December 5 to 19, 2025; Biote Corp. Form 8-K, January 26, 2026; FDA Enforcement Report database

FDA cited Boothwyn Pharmacy, in warning letter #717525, following a May 12 to June 9, 2025 inspection for insanitary conditions and significant problems involving sterile compounded products. FDA documented distribution of products associated with out-of-specification sterility or potency results and deficiencies in procedures governing release of products before final sterility testing was complete. Examples identified by FDA included a semaglutide product with approximately 80% of labeled potency, tirzepatide products with approximately 87% and 89% of labeled potency, and subpotent fluorescein ophthalmic solution at approximately 86% and 76% of labeled strength. Boothwyn initiated a voluntary recall on July 9, 2025 of within-expiry products associated with out-of-specification results, and ceased production of sterile GLP-1 drug products.

Three findings in the letter are worth close attention by 503A pharmacies. First, FDA stated that between July 2, 2024 and May 1, 2025 the firm distributed products intended to be sterile that failed sterility and potency specifications. Second, FDA reviewed 23 variance and out-of-specification investigation reports from November 2024 through May 2025 and found that none followed the firm’s own investigation procedure, none documented contact with the affected patient, and 19 remained open at the time of the inspection. Third, FDA identified standard operating procedures that permitted release of sterile preparations “at risk,” before final sterility results, without limiting the practice to ophthalmic preparations and without specifying whether prescribers or patients would be notified if a released product later failed sterility testing.

The warning letter also makes an important regulatory point for 503A pharmacies. FDA stated that the prohibition on preparing, packing, or holding drugs under insanitary conditions in section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act applies regardless of whether a compounded drug otherwise satisfies the conditions of section 503A. In other words, qualification for the 503A exemptions does not insulate a pharmacy from federal adulteration requirements related to insanitary conditions.

Separately, on October 21, 2025, the Pennsylvania Department of State announced that Boothwyn had entered a consent agreement carrying a $1 million civil penalty and probation of its pharmacy license, related to compounding and packaging injectable weight-loss medications in facilities that had not been inspected and approved by the State Board of Pharmacy. Boothwyn admitted to violating the Pharmacy Act and Board regulations.

FDA’s warning letter database identifies a single Boothwyn warning letter in this period, #717525, dated January 16, 2026.

Sources: Warning Letter, Boothwyn Pharmacy, LLC, #717525, January 16, 2026; Pennsylvania Department of State news release, October 21, 2025

FDA cited MedisourceRx for failing to submit a required adverse-event report and for procedures that did not adequately define what constitutes a “serious” adverse event under 21 CFR 310.305(b). The underlying inspection record describes a complaint involving a patient who reported severe gastrointestinal symptoms and a three-night hospitalization after receiving compounded semaglutide injection. The firm subsequently submitted the outstanding reports retroactively.

Registered outsourcing facilities have a federal obligation under section 503B(b)(5) to report certain adverse drug experiences to FDA. Failure to meet that requirement can be actionable independently of whether FDA identifies a defect in the compounded product itself.

FDA issued a closeout letter to MedisourceRx on July 27, 2026, stating that, based on its evaluation, the company appeared to have adequately addressed the violations described in the warning letter. FDA noted that the closeout did not preclude future regulatory action if warranted.

Sources: Warning Letter, MedisourceRx, #717970, December 12, 2025; Closeout Letter, MedisourceRx, #717970, July 27, 2026

FDA cited Apothecary Pharma, in warning letter #717972, following a May 12 to May 15, 2025 inspection for violations of current good manufacturing practice requirements and failure to meet conditions associated with section 503B. Among other findings, FDA identified labeling deficiencies involving compounded tirzepatide and semaglutide products. Certain labels did not include required information concerning active and inactive ingredients and their quantities or proportions, and FDA identified deficiencies in directions for use and information intended to facilitate adverse-event reporting.

The firm stopped sterile production on May 12, 2025. According to the warning letter, Apothecary Pharma subsequently notified FDA that it intended to resume sterile operations beginning August 1, 2025.

Sources: Warning Letter, Apothecary Pharma, LLC, #717972, December 1, 2025; Form FDA 483, Apothecary Pharma, LLC, issued May 15, 2025

FDA posted another coordinated group of warning letters to telehealth companies on June 16, 2026. The 25 letters were dated June 8, 2026. They continued to focus on false or misleading claims about compounded semaglutide and tirzepatide, including claims that products contained the “same ingredient” as FDA-approved drugs, use of a telehealth company’s branding in a manner that could obscure the actual compounder, and statements referring to an “FDA licensed” or “FDA approved” compounding pharmacy or facility. FDA does not license or approve pharmacies or outsourcing facilities in that manner.

FDA also published a dedicated resource for telehealth companies describing practices that may result in false or misleading promotion of compounded drugs.

For the March and June 2026 telehealth actions, FDA principally alleged misbranding under sections 502(a) and 502(bb) of the FD&C Act. Section 502(a) addresses false or misleading labeling; section 502(bb) specifically provides that a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.

These promotional allegations are legally distinct from the question of whether a particular compounded preparation satisfies the conditions of section 503A or 503B. Some September 2025 letters, however, alleged additional violations, including the marketing of unapproved new drugs. The enforcement actions therefore should not all be characterized as resting on a single legal theory.

Sources: FDA, FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs; Regulatory Affairs Professionals Society, FDA cites companies for CGMP violations, telehealth firms for illegally marketing GLP-1 drugs; Telehealth.org, FDA Warns 25 Firms Over Compounded GLP-1 Claims

FDA announced that it had issued 30 warning letters to telehealth companies over the marketing of compounded GLP-1 products. FDA identified two recurring problems: claims that implied compounded semaglutide or tirzepatide was the same as or equivalent to an FDA-approved product, and branding or labeling that could create the impression that the telehealth company itself compounded the drug when another entity actually prepared it. FDA described this as the second group of telehealth warning letters following its September 2025 enforcement initiative.

Sources: FDA Warning Letters database; Warning Letter, MEDVi, LLC, #721455, February 20, 2026, applying the same statutory theory; BioSpace, FDA Sends 30 Warning Letters to Continue Clampdown on Compounded GLP-1s

FDA issued a broad group of warning letters involving false or misleading promotion of compounded drugs, most of them dated September 9, 2025. The letters included companies marketing compounded semaglutide and tirzepatide as well as other compounded or unapproved products. Examples included claims suggesting that compounded products were the same as, equivalent to, or had the same active ingredient as FDA-approved products. Other letters addressed compounded sildenafil and tadalafil, while some letters involving investigational peptides such as retatrutide also alleged distribution of unapproved new drugs.

CDER’s Office of Compliance Annual Report 2025, published in April 2026, states that the office issued 72 compounding-related warning letters during the year, of which 58 addressed misbranded compounded drugs promoted through false or misleading advertising. Those figures cover calendar year 2025, January 1 through December 31, and should not be interpreted as the number of letters issued in the September enforcement action alone.

Sources: CDER Office of Compliance Annual Report 2025; Warning Letter, JulyMD, #716828, September 9, 2025, representative of this group; Wilson Sonsini, FDA Sends Warning Letters to More Than 50 GLP-1 Compounders and Manufacturers

FDA announced that it intended to take action to restrict GLP-1 active pharmaceutical ingredients intended for use in non-FDA-approved compounded drugs that were being mass-marketed as alternatives to FDA-approved products. The agency’s statement named Hims & Hers and other compounding pharmacies. FDA also said it would continue taking action against misleading direct-to-consumer promotion of compounded GLP-1 products.

FDA stated that companies marketing compounded products may not falsely imply that those products are generic versions of, the same as, or equivalent to FDA-approved products. The agency warned that entities that fail to adequately address violations may face legal action, including seizure or injunction.

Sources: FDA Press Announcements; Pharmacy Times, FDA Moves to Restrict Mass-Marketed Compounded GLP-1 Products; McDermott+, FDA’s Makary Declares Upcoming Crackdown on GLP-1 Claims, Importation; Hims & Hers Health, Inc., Form 10-Q, confirming the company was directly named

FDA issued warning letter 320-26-73 to Harbin Jixianglong Biotech following a November 3 to November 7, 2025 inspection of the peptide API manufacturer. FDA found that Harbin had purchased semaglutide API manufactured by other suppliers, repackaged and relabeled the material under Harbin’s name, assigned new batch numbers, and changed manufacturing and retest dates without adequate supporting data before distributing the material to the United States.

The import-alert history is particularly significant. FDA implemented the Green List under Import Alert 66-80 on September 5, 2025, and Harbin was added to that list the same day based on quality information previously provided to FDA. According to the warning letter, Harbin subsequently obtained semaglutide API from a manufacturer that was not on the Green List, labeled that API in a manner identifying Harbin rather than the actual manufacturer, and shipped the material to the United States. FDA stated that this conduct raised concern that the labeling may have been intended to circumvent the safeguards associated with Import Alert 66-80.

Harbin initiated a voluntary recall of two distributed semaglutide API batches on February 19, 2026. On February 27, 2026, FDA removed Harbin from the Import Alert 66-80 Green List and placed the firm on Import Alert 66-40, which addresses drugs from firms that have not met drug current good manufacturing practice requirements.

FDA also documented broader manufacturing-quality problems. These included a lack of process validation for semaglutide batches distributed to the United States; inadequate cleaning validation for equipment used for multiple peptide APIs, including semaglutide and tirzepatide; incomplete analytical method validation or bacterial endotoxin method verification for certain tirzepatide lots; and inadequate evaluation of water used in the manufacture of APIs intended for sterile injectable drug products.

Beyond the CGMP findings, FDA cited Harbin for failing to list the relabeled semaglutide under section 510(j) of the FD&C Act and for misbranding under sections 502(a) and 502(b)(1), because the container labels identified Harbin as the manufacturer when other firms had manufactured the material. FDA also rejected Harbin’s proposal to place “R&D use” language on material destined for certain customers, noting among other things that the quantities shipped were inconsistent with typical research-and-development quantities.

For compounders and purchasers, the action underscores the importance of verifying the actual API manufacturer and its current regulatory and import-alert status rather than relying solely on the name appearing on a container, a certificate of analysis, or a drug listing.

Source: Warning Letter 320-26-73, Harbin Jixianglong Biotech Co., Ltd., #723330, May 1, 2026

Two FDA import alerts are particularly relevant to the GLP-1 API supply chain.

Import Alert 66-80 is titled “Detention Without Physical Examination of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances.” FDA implemented a Green List under the alert on September 5, 2025. The alert permits FDA to detain covered GLP-1 bulk drug substances from firms that do not qualify for the Green List without physically examining each shipment. Green List status is based on information FDA evaluates concerning the manufacturer and its products and can change over time.

Import Alert 66-40 is broader. It is titled “Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs” and applies to drugs and drug products from identified firms with current good manufacturing practice concerns.

A manufacturer can be removed from the 66-80 Green List and placed on 66-40 when FDA identifies broader CGMP concerns, as occurred with Harbin in February 2026. Because import-alert status can change, purchasers of GLP-1 API should verify the current FDA status of the actual manufacturing site when sourcing material.

Sources: Import Alert 66-80; Import Alert 66-40

FDA states that retatrutide and cagrilintide cannot be used in compounding under federal law. Neither drug is currently a component of an FDA-approved drug, and FDA has not found either drug safe and effective for any condition. FDA has warned telehealth companies marketing retatrutide, API distributors selling it to compounders, and outsourcing facilities repackaging it.

As of May 31, 2026, FDA reported receiving 990 adverse-event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. FDA cautions that it is not always possible to determine whether an adverse event resulted from use of the drug. FDA also notes that adverse events associated with compounded drugs are likely underreported, because federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse-event reports to FDA.

FDA has separately documented counterfeit versions of FDA-approved GLP-1 products entering U.S. distribution channels. On December 5, 2025, FDA reported that it had seized dozens of counterfeit Ozempic 1 mg units that had been distributed outside Novo Nordisk’s authorized supply chain and had entered the legitimate U.S. drug supply chain.

Sources: FDA, FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, content current as of September 1, 2026; FDA, FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain