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Compounding Watch

What the FDA and the boards did, with the source one click away.

Twice a day, an AI agent checks the Federal Register, the FDA's compounding pages and the boards of pharmacy in all 50 states and DC, then writes up what changed for 503A and 503B pharmacies. You read it here, free.

Last checked Oct 29, 5:16 PM CDT · 124 sources watched

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High-impact, 30 days
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Entries, 30 days
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States with activity
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Boards meeting soon
The feed

Latest actions

7 entries
  1. Wednesday, October 28, 2026
    FederalHighFederal actionHealth and Human Services Department

    Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances

    HHS announced a draft Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (Docket No. HHS-OASH-2026-0496), scheduled for Federal Register publication on 2026-10-30. Under the policy, HHS does not intend to take enforcement action against a state-licensed pharmacy, federal facility or licensed physician compounding a drug product using a peptide bulk drug substance listed in Appendix A while the 503A bulks list is developed through rulemaking. HHS says FDA's future rulemakings may propose adding some or all of these peptides to the 503A bulks list. HHS may revisit the interim policy if a safety signal or product quality issue arises, and the policy is not binding on HHS or the public. Written comments are accepted via regulations.gov until two weeks after the publication date.

    Why it mattersYou should get the policy and its Appendix A from the HHS website, check which peptides you compound against that list, and file any comments on regulations.gov within the two-week window.

    PeptidesBulks / Category 2Federal Register 2026-22192

    Written by AI from the source document. Verify before you act.

  2. Friday, September 18, 2026
    FederalMediumWarning letterFDA

    FDA issues warning letter to Empower Pharmacy's Houston 503A facility

    FDA's compounding inspections and actions page lists a warning letter issued 09/18/2026 to Empower Clinic Services, LLC (dba Empower Pharmacy), Houston, TX, for its 503A facility. The same entry lists a Form 483 issued 11/14/2025 and an earlier warning letter issued 04/02/2025. The listing does not describe the contents of the new letter.

    Why it mattersRead the letter when FDA posts the full text, and compare the cited issues with your own 503A compounding practices and records.

    EnforcementCompounding: Inspections, Recalls, and other Actions

    Written by AI from the source document. Verify before you act.

  3. Wednesday, September 9, 2026
    FederalMediumGuidanceHealth and Human Services Department / Food and Drug Administration

    Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability

    FDA announced a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates" (Docket No. FDA-2026-D-9571). It sets out FDA's regulatory and enforcement priorities for compounding these products by 503B outsourcing facilities and by state-licensed pharmacies and federal facilities operating under section 503A. FDA issued it for immediate implementation without prior public comment under 21 CFR 10.115(g)(2), citing the expected market exit of the predominant U.S. source of these products. The guidance mentions records on which patients received specific compounded products. Comments may be submitted at any time.

    Why it mattersIf you supply parenteral nutrition to hospitals or NICUs, read the full guidance on FDA's guidance page to see which products and conditions it covers, and check that your patient-level dispensing records match what it describes.

    Sterile compounding503B outsourcingEnforcementEffective Sep 9, 2026Federal Register 2026-18368

    Written by AI from the source document. Verify before you act.

  4. FederalLowFederal actionFDA

    FDA posts Form 483 issued to Greenwich Rx in Tomball, Texas

    FDA's compounding inspections and actions page lists a Form 483 issued 09/09/2026 to Greenwich Rx, Tomball, TX, a 503A facility. The 483 is posted as a 2.4 MB PDF. No earlier FDA actions are listed for this firm.

    Why it mattersReview the posted 483 observations to see what FDA investigators are citing at 503A pharmacies and check your own procedures against them.

    EnforcementCompounding: Inspections, Recalls, and other Actions

    Written by AI from the source document. Verify before you act.

  5. Thursday, September 3, 2026
    FederalLowFederal actionFDA

    FDA posts Form 483 issued to Olympia Pharmacy outsourcing facility in Orlando

    FDA's compounding inspections and actions page lists a Form 483 issued 09/03/2026 to OPS International, Inc. (dba Olympia Pharmacy), Orlando, FL, a 503B facility. Earlier entries for the firm include an amended 483 issued 08/08/2025, a 483 issued 05/29/2024, a regulatory meeting held 02/22/2023 and a 483 issued 03/02/2022.

    Why it mattersIf you operate or buy from a 503B outsourcing facility, review the posted observations and compare them with your CGMP controls or supplier qualification.

    Enforcement503B outsourcingCompounding: Inspections, Recalls, and other Actions

    Written by AI from the source document. Verify before you act.

  6. Monday, August 31, 2026
    FederalLowComment deadlineHealth and Human Services Department / Food and Drug Administration

    Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facili...

    FDA published a Paperwork Reduction Act notice (Docket No. FDA-2026-N-8690) proposing to extend OMB Control Number 0910-0776, which covers outsourcing facility registration under section 503B and fees under section 744K. Comments are due by October 30, 2026. The notice restates that outsourcing facilities must register annually between October 1 and December 31, submit drug product reports in SPL format in June and December, and request the small business fee reduction on Form FDA 3908 by April 30 of the preceding fiscal year. FDA estimates 100 registrants, 213 annual responses and 704 burden hours, noting a slight increase in registrations and a decrease in reinspection fee submissions.

    Why it mattersIf you run a 503B outsourcing facility, file any comments on the registration and fee burden by October 30, 2026, and confirm your annual registration falls between October 1 and December 31.

    503B outsourcingFederal Register 2026-17676

    Written by AI from the source document. Verify before you act.

  7. Friday, August 28, 2026
    FederalMediumComment deadlineHealth and Human Services Department / Food and Drug Administration

    Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industr...

    The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled "Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities." This draft guidance, when finalized, will describe FDA's current thinking regarding the circumstances under which we generally do not intend to take action against the compounding of animal drug products from bulk drug substances (BDS) when done in accordance with Current Good Manufacturing Practice (CGMP) at drug production facilities that are registered with FDA.

    Why it mattersComments close Nov 27, 2026; read the document and file before then if it affects your compounding.

    Bulks / Category 2Federal Register 2026-17580

    Federal Register record

At the boards

This week and next

Oct 26 to Nov 8, 2026. Agenda lines that touch compounding, nonresident licensing, operations or discipline are pulled out under each meeting.

No board meetings posted for these two weeks yet. Boards often post agendas a few days ahead.

Check by hand: the agent can't read Alaska, Arizona, Colorado, Kansas, Massachusetts, Maine, Michigan, Minnesota, New Hampshire, New Jersey, Tennessee automatically, so watch those boards' sites yourself.

How this works

The agent reads every source and drafts the entry. You read the document and make the call.

Before you rely on an entry

Read the source, every time

Entries are written by an AI model (Claude) from the primary document and published automatically, without a person reviewing each one first. The model reports only what the document says, and every entry links to that document, but it can still misread a date or miss a condition.

Compounding Watch is education, not legal or regulatory advice. Before you change how you compound, ship or license, open the source and check it with your board or counsel. Spot an error? Use the contact page and it gets corrected.

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