FedEx trackedLot COA librarySupport 8:00 AM – 9:00 PM ETFree shipping on orders $85+

Research community

News

Updated

Image: BioLabs Research

The HHS peptide docket now shows 12 comments. What that number decides — and what it does not

The Federal Register record for HHS's notice of availability on 503A compounding with certain peptide bulk drug substances (FR Doc. 2026-22192, published 30 October 2026 at 91 FR 68526) now carries a regulations.gov comment count of 12, as of the API refresh checked on the morning of 5 November 2026 (UTC).

Image: BioLabs Research

USP says the HHS peptide policy lacks key quality safeguards. What a monograph would add

The US Pharmacopeia (USP), the standards body behind the USP–NF quality monographs, said on 3 November 2026 that the peptide compounding policy the Department of Health and Human Services released the week before does not include essential safeguards to help ensure the quality of compounded preparations.

Image: BioLabs Research

Category 1, 2 or 3? How FDA sorts substances nominated for the 503A list

FDA sorts bulk drug substances nominated for the 503A bulks list into three categories while it reviews them, and the label decides how FDA approaches compounding with that substance in the meantime.

Image: BioLabs Research

The next FDA peptide advisory meeting: what it can and cannot decide

FDA says its Pharmacy Compounding Advisory Committee will meet before the end of February 2027 to discuss five peptide bulk drug substances nominated for the 503A bulks list, the list of ingredients that state-licensed pharmacies and physicians may use for compounding under section 503A of the Federal Food, Drug, and Cosmetic Act.

Image: BioLabs Research

503A or 503B? Why the HHS peptide policy covers only one kind of pharmacy

The peptide compounding policy that the Department of Health and Human Services announced in the Federal Register on 30 October 2026 (FR Doc. 2026-22192, Docket HHS-OASH-2026-0496) is written for one part of the compounding system only.

Image: BioLabs Research

Why HHS went ahead on six compounding peptides after FDA's drug center said no

The draft peptide compounding policy that the Department of Health and Human Services published on 30 October 2026 (FR Doc. 2026-22192, Docket HHS-OASH-2026-0496) openly departs from the advice of FDA's own drug center.

Image: BioLabs Research

HHS peptide compounding policy is now in the Federal Register: the ten conditions and the COA test list

The Department of Health and Human Services' notice announcing a draft "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" is published in the Federal Register on 30 October 2026 (FR Doc. 2026-22192, Docket HHS-OASH-2026-0496, RIN 0910-ZD94), after it was filed for public inspection on 28 October.

Image: BioLabs Research

PolyPeptide shareholders hand the board to Samsung Biologics as the peptide CDMO takeover nears close

PolyPeptide Group, the Swiss contract developer and manufacturer of peptide-based active pharmaceutical ingredients, said on 26 October 2026 that its shareholders approved every board proposal at an extraordinary general meeting in Baar, electing five nominees put forward by Samsung Biologics, including a new chair.

Image: BioLabs Research

Mississippi pharmacy board says a certificate of analysis alone does not make a peptide compoundable

The Mississippi Board of Pharmacy's October 2026 newsletter publishes a question-and-answer follow-up to the joint statement on research-grade peptides that the state's boards of pharmacy, nursing and medical licensure issued on 19 August 2026, and one answer addresses a common question about certificates of analysis directly: "A certificate of analysis alone does not satisfy the concerns of the statement." It appears while FDA's federal notice "Interim Access Policy for Compounding Using Certain Peptides" (RIN 0910-ZD94) is still under White House review, with its text, covered substances and conditions unpublished.

Image: BioLabs Research

JAMA Viewpoint argues FDA advisory committee peptide votes threaten the drug approval process

A Viewpoint published in the Journal of the American Medical Association (JAMA) on 26 October 2026 by three authors from the Center for Science in the Public Interest (CSPI), a consumer advocacy group, argues that following the July recommendations of FDA's Pharmacy Compounding Advisory Committee would expose the public to unproven peptides and undermine both the advisory committee system and FDA's drug approval process.