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โš  Regulatory Alert Coming soon ยท July 23-24, 2026

FDA Pharmacy Compounding Advisory Committee (PCAC) meeting: July 23-24, 2026

The U.S. Food and Drug Administration's Pharmacy Compounding Advisory Committee is scheduled to meet on July 23-24, 2026 to review bulk drug substances nominated for pharmacy compounding, including peptides such as BPC-157 and TB-500.

Why it matters: The committee's recommendations could affect whether these and other peptides remain available as pharmacy-compounded preparations. This is an informational heads-up, not medical or legal advice.

Official FDA meeting page โ†’

LEAD STORY ยท 2026-07-03

Michigan HB 6172: Animals: animal shelters; cross-references to 1969 PA 287 in public health code; update. TIE BAR WITH: HB 6167'26

bill electronically reproduced 07/03/2026

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Latest Updates

2026-06-26
Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661

The Food and Drug Administration (FDA, Agency, or we) is extending the effective date of the notice published in the Federal Register on May 27, 2026, titled Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-C...

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2026-06-26
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act" th...

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2026-06-24
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry titled "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products." FDA has revis...

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2026-06-24
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Chickens-Gallus Gallus; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #114 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Chickens--Gallus gallus." This guidance has b...

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2026-06-18
SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 202608 for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) tablets, 27 milligrams (mg), 36 mg, and 54 mg, held by ...

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2026-06-16
Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on February 20, 2026. The document announced the withdrawal of approval of 11 abbreviated new drug applications (ANDAs) from multiple applic...

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2026-06-09
Ohio HB 963: Revise the law governing the practice of physician assistants

Referred to committee

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2026-06-01
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products." Whe...

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2026-05-29
Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Patient-Focused Drug Development for Nonhealing Chronic Wounds." The purpose of the public meeting is to obtain patient perspecti...

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2026-05-28
Louisiana HCR 120: INSURANCE: Creates the PACE Task Force to prioritize access, care, and education on GLP-1 medications

Received in the Senate; read by title. Rules suspended. Read second time by title and concurred in by a vote of 33 yeas and 0 nays. Ordered returned to the House.

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2026-05-26
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required...

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2026-05-01
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act

The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourci...

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2026-04-16
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations ...

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2026-04-15
Massachusetts S 3064: An Act to build resilience for Massachusetts communities

Committee recommended ought to pass with an amendment, striking out all after the enacting clause and inserting the text of H5510, and referred to the committee on House Steering, Policy and Scheduling

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2026-04-01
Louisiana HB 1093: HEALTH: Creates the Louisiana Board of Naturopathic Medicine

Read by title, under the rules, referred to the Committee on Health and Welfare.

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2026-04-01
Prospective Grant of an Exclusive Patent License: Pigment Epithelium-Derived Factor (PEDF) Peptides and Use for Treating Retinal Degeneration

The National Eye Institute, an institute of the National Institutes of Health, United States Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the paten...

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2026-03-06
Rhode Island HB 8245: AN ACT RELATING TO INSURANCE -- ACCIDENT AND SICKNESS INSURANCE POLICIES

03/30/2026 Committee recommended measure be held for further study

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2026-03-02
Minnesota HF 3825: Health occupations; licensing and scope of practice modified for acupuncture and herbal medicine practice, athletic training, mortuary science, social work, dentistry practice, marr

Secretary of State Chapter 115 05/27/26

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2026-02-20
Government Owned Inventions Available for License: Novel Human Immunogenic Epitopes of the Human Endogenous Retrovirus ERVMER34-1

The National Cancer Institute (NCI), an institute/center of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the license opportunity for the invention listed below, which is owned b...

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2026-02-06
Kansas SB 497: Adding kratom to schedule I of the uniform controlled substances act and making conforming amendments to the definition of fentanyl-related controlled substance in the criminal code.

Died in House Committee

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2026-02-06
Kansas HB 2765: Adding and removing certain substances in schedules I, III and IV of the uniform controlled substances act and making conforming changes to the criminal code definition of fentanyl-rel

Stricken from Calendar by Rule 1507

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2026-01-12
Kansas SB 303: House Substitute for SB 303 by Committee on Taxation - Decreasing the rate of ad valorem tax imposed by a school district, discontinuing certain sales tax exemptions, imposing sales tax

Died on House Calendar

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2025-09-16
Michigan HB 4947: Health: pharmaceuticals; manufacturers of products containing ephedrine or pseudoephedrine; require to participate in a national logging system. Amends secs. 7340 & 7340a of 1978 PA

REFERRED TO COMMITTEE ON HEALTH POLICY

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2025-08-27
Government Owned Inventions Available for Licensing or Collaboration: RFXP1 AGONISTS

The National Center for Advancing Translational Sciences (NCATS), an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the licensing opportunities for the inventions lis...

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2025-08-04
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2026 Rates; Changes to the FY 2025 IPPS Rates Due to Court Decision; Requirements for Quality Programs; and Other Policy Changes; Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization

This final rule revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; makes changes relating to Medicare graduate medical education (GME) for teaching hos...

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2025-07-30
Texas SB 54: Relating to the regulation of the cultivation, manufacture, processing, distribution, sale, testing, transportation, delivery, transfer, possession, use, and taxation of cannabis and cann

Filed

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2025-07-24
Texas HB 195: Relating to the regulation of the cultivation, processing, packaging, labeling, distribution, sale, testing, transportation, delivery, transfer, storage, dispensing, possession, use, and

Filed

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2025-07-24
Pennsylvania SB 866: An Act amending the act of April 14, 1972 (P.L.233, No.64), known as The Controlled Substance, Drug, Device and Cosmetic Act, further providing for schedules of controlled substan

First consideration

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2025-07-10
Pennsylvania SB 120: An Act providing for cannabis; regulating the personal use and possession of cannabis; establishing the Cannabis Control Board; providing for powers and duties of the Cannabis Con

Resolution to discharge committee from further consideration of this bill presented

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2025-05-12
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of butterfly pea flower extract as a color additive in ready-to-eat cereals, crackers, snack mixes, hard pretzels, ...

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2025-04-15
Alaska HB 195: An Act changing the term 'physician assistant' to 'physician associate'; relating to physician associates; relating to collaborative practice agreements for pharmacists; relating to the

(H) DUE BACK FROM GOVERNOR 6/18/26

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2025-02-20
Michigan SB 94: Health: pharmaceuticals; drug manufacturers from engaging in certain conduct with pharmacies participating with a 340B program; prohibit. Amends 1978 PA 368 (MCL 333.1101 - 333.25211)

referred to Committee on Health Policy

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2025-02-20
Maine LD 627: An Act To Require Insurance Coverage For Glucagon-Like Peptide-1 Receptor Agonist Medication

Pursuant to Joint Rule 310.3 Placed in Legislative Files (DEAD)

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2025-01-22
Pennsylvania SB 95: An Act amending the act of September 27, 1961 (P.L.1700, No.699), known as the Pharmacy Act, further providing for definitions, for licensing of pharmacists and for unlawful acts;

Act No. 34 of 2025

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2025-01-21
Kansas SB 52: Enacting the Kansas film and digital media industry production development act, providing a tax credit and sales tax exemption to incentivize film, video and digital media production in

Died on House Calendar

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2024-12-31
Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Reopening of the Comment Period

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments notice entitled "Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Pro...

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2024-12-20
Hazardous Drugs: NIOSH List of Hazardous Drugs in Healthcare Settings, 2024 and Final Reevaluation Determinations for Liraglutide and Pertuzumab

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the publication of the NIOSH List of Hazardous Drugs ...

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2024-11-27
Supplemental Evidence and Data Request on Dietary Intake of Polyunsaturated Fatty Acids and Plasma Lipid and Cardiovascular Events

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Dietary Intake of Polyunsaturated Fatty Acids and Plasma ...

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2024-11-25
Supplemental Evidence and Data Request on Dietary Saturated Fat Replacement and Plasma Lipid and Cardiovascular Events

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Dietary Saturated Fat Replacement and Plasma Lipid and Ca...

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