NCPA submits comments to HHS, calling for de-regulation by CMS, DEA/SAMHSA, FDA

NCPA July 15, 2025

NCPA submitted comments to HHS, calling for de-regulation from the Centers for Medicare & Medicaid Services, Drug Enforcement Administration/Substance Abuse and Mental Health Services Administration, and the Food and Drug Administration.

NCPA requested that CMS eliminate pharmacies' mandatory participation in the Medicare Drug Price Negotiation Program via PBM/plan contracts, and rescind the Medicare Part B requirement for a beneficiary's signature on a reimbursement claim.

NCPA's ask to SAMHSA and DEA was that these agencies should rescind joint rules requiring pharmacists to verify the identity of patients filling prescriptions for buprenorphine to treat opioid use disorder that were issued on the basis of a telemedicine encounter.

NCPA asked the FDA to de-regulate compounding, including that the agency suspend its MOU with state boards of pharmacy indefinitely, given our multiple concerns; eliminate its proposed rule on demonstrable difficulties for compounding; and rescind its 2023 Guidance for Industry #256 (GFI 256) governing compounding of animal drugs.

NCPA also asked the FDA to modify its Nonprescription Drug Products with Additional Conditions for Nonprescription Use (ACNU) final rule to standardize the ACNU process and incorporate the role of the pharmacist.

NCPA