HHS opens door to pharmacy compounding of six unapproved peptides

-HHS opens door to pharmacy compounding of six unapproved peptides

The department says it will not enforce against 503A compounders making BPC-157 and five other peptides, under conditions.

In a notice filed with the Federal Register on October 28 and signed by Secretary Robert F. Kennedy Jr., HHS said it “does not intend to take enforcement action” against state-licensed pharmacies, federal facilities or licensed physicians who compound with six peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 [1][2]. The interim policy requires a certificate of analysis from a registered manufacturer, serious adverse event reporting to MedWatch and “Not for resale” labeling, and it runs until a final rule settles each peptide’s status [1][2]. It does not cover 503B outsourcing facilities, and Public Citizen criticized it for allowing “unproven and potentially unsafe peptides” to reach patients [3].

-CDC’s new threats report counts 9.7 million drug-resistant infections and 50,800 deaths a year

The report names 19 pathogens, four of them urgent, and says the totals cannot be compared with 2019.

The CDC’s Antimicrobial Resistance Threats Report, dated October 27 and built on 2023 data, estimates 9.7 million infections and 50,800 deaths a year in the US, with four urgent threats: Candida auris, carbapenem-resistant Enterobacterales, carbapenem-resistant Acinetobacter and drug-resistant gonorrhea [4]. The agency cautioned against comparing the totals with the 2019 report’s 2.8 million infections and 35,000 deaths because surveillance methods changed, but reported 4,523 C. auris cases in 2023, a tenfold rise since 2019 [5].

-Virginia mental health company co-owner charged in $49 million Medicaid fraud scheme

Prosecutors allege crisis-team billing for solo providers and $2 million in hotel rooms for patients.

DOJ announced October 28 that Mikia Antoneice Noble, 37, co-owner and chief operating officer of Advancing Communities Everywhere LLC near Richmond, was arrested on an indictment charging conspiracy and three counts of health care fraud [6]. The indictment alleges that from January 2022 through April 2026 the company submitted over $49 million in false claims to Virginia Medicaid, billed crisis services as team-delivered when a single lower-level provider showed up, added signatures of licensed professionals who did not participate and spent over $2 million on hotel rooms to induce beneficiaries to accept unneeded services [6]. Noble is presumed innocent [6].

-CVS sues CMS over 2027 Medicare Advantage star ratings, citing a $2 billion hit

At least five insurers have now challenged the measures behind this year’s scores.

CVS Health’s Aetna filed a complaint in the Southern District of Georgia asking the court to vacate star ratings for dozens of its contracts and recalculate them without 28 disputed measures, the most any insurer has challenged [7]. The company says it stands to lose $2 billion in 2028 payments after the share of its members in plans rated 4 stars or higher fell from 84% to 67%; Alignment, SCAN, Healthfirst and Centene have filed similar suits [7]. Star ratings litigation is becoming a fixture of open enrollment season.

Digest references

  1. U.S. Department of Health and Human Services, “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances” (notice of availability), Federal Register public inspection, filed October 28, 2026. https://public-inspection.federalregister.gov/2026-22192.pdf

  2. U.S. Department of Health and Human Services, “HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances,” HHS.gov, October 2026. https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf

  3. Sydney Lupkin, “Trump administration will allow pharmacies to make popular peptides,” NPR via KPBS, October 28, 2026. https://www.kpbs.org/news/health/2026/10/28/trump-administration-will-allow-pharmacies-to-make-popular-peptides

  4. Centers for Disease Control and Prevention, “Antimicrobial Resistance Threats Report,” CDC, October 27, 2026. https://arpsp.cdc.gov/artr

  5. Caitlyn Stulpin, “Millions at risk for drug-resistant infections, CDC says,” Healio, October 27, 2026. https://www.healio.com/news/infectious-disease/20261027/millions-at-risk-for-drugresistant-infections-cdc-says

  6. U.S. Department of Justice, Office of Public Affairs, “Virginia Mental Health Professional Charged in $49M Medicaid Fraud Scheme,” October 28, 2026. https://www.justice.gov/opa/pr/virginia-mental-health-professional-charged-49m-medicaid-fraud-scheme

  7. Rebecca Pifer Parduhn, “CVS sues to prevent $2B Medicare Advantage star ratings hit,” Healthcare Dive, October 28, 2026. https://www.healthcaredive.com/news/cvs-aetna-lawsuit-medicare-advantage-star-ratings-2027-cms-2-billion/873000/

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