WeVote
Log In

Bill

Bill

S 1497

Relates to the paper carryout bag reduction fee

2025 Regular Session Introduced by Pat Fahy

Prohibits resale of compounded meds by retail pharmacies to protect patient safety; adds strict labeling, transfer limits, and office-use controls.

REPORTED AND COMMITTED TO FINANCE
0
WeVote Research Nonpartisan
Bill Summary · S 1497

Summary — S.1497 (194th General Court, 2025‑2026)

Short title: An Act protecting patient safety regarding non‑FDA approved drugs
Bill number: S 1497
Filed: 01/16/2025 (Senate Docket No. 1379) — introduced 04/10/2025
Current status: Reported and committed to Finance; hearing scheduled 06/11/2025 (see Legislative actions).
Note on inconsistencies: The provided metadata contains conflicting information (a different title referencing paper bags, and different sponsor names). The bill text in the docket and petition is authored/presented by Sen. John J. Cronin and concerns compounded/non‑FDA approved drugs. This summary follows the bill text.

Purpose / Intent

To strengthen controls on the distribution, labeling, and resale of compounded medications and drugs repackaged by outsourcing facilities, with the stated goal of protecting patient safety when drugs not subject to FDA approval are used.

Key definitions (selected)

  • Compounded Medication: A drug prepared or modified by a licensed pharmacist to meet an individual patient’s needs pursuant to a prescription.
  • Retail Pharmacy: A state‑licensed establishment that dispenses prescription medications directly to patients.
  • Resale: Selling, distributing, or otherwise transferring a medication purchased by a retail pharmacy to any party other than the patient for whom it was originally compounded.

Major provisions and requirements

  1. Prohibition on resale by retail pharmacies

    • Retail pharmacies are prohibited from reselling compounded medications; compounded meds must be dispensed only to the patient for whom they were compounded and only pursuant to a valid prescription.
    • Violations subject the pharmacy to disciplinary action by the Board of Registration in Pharmacy (fines, suspension, license revocation).

  2. Labeling requirements for drugs compounded or repackaged by an outsourcing facility

    • Labels must clearly identify the product as compounded and include the outsourcing facility’s name, address, and phone.
    • Required drug information: lot/batch number; established drug name; dosage form and strength; quantity/volume; compounding date; expiration date; storage/handling instructions; NDC if available; statement “not for resale” and, if distributed without an individual patient prescription, the statement “office use only”; list of active/inactive ingredients with quantities/proportions.

  3. Container/unit labeling

    • Containers from which units are removed for dispensing must list active/inactive ingredients, provide FDA MedWatch adverse event reporting info (www.fda.gov/medwatch and 1‑800‑FDA‑1088 or successor), and directions for use (including dosage/administration as appropriate).

  4. Transfer restrictions

    • No entity other than the outsourcing facility that compounded/repackaged a drug may sell or transfer it. Exemptions: administration in a health care setting and dispensing pursuant to a proper prescription by the outsourcing facility.

  5. “Office use only” drugs

    • If labeled “office use only,” the drug must be administered in the office and may not be dispensed to the patient for take‑home.

Enforcement and rulemaking

  • The Massachusetts Board of Registration in Pharmacy is authorized to enforce the Act and to promulgate implementing regulations.
  • Sanctions may include fines, suspension, or revocation of a pharmacy license.

Who is affected

  • Retail/community pharmacies (restrictions on resale and dispensing practices)
  • Outsourcing facilities (expanded labeling, distribution, and transfer limits)
  • Prescribers and health care offices (limits on obtaining compounded product for office use; must administer “office use only” products)
  • Patients (may affect access pathways to certain compounded medications)
  • State Board of Registration in Pharmacy (enforcement responsibilities)

Potential impacts and considerations

  • Patient safety: improved traceability and adverse event reporting for compounded products.
  • Compliance costs: increased labeling, recordkeeping, and potential operational changes for pharmacies and outsourcing facilities.
  • Supply/administration logistics: limits on resale and transfer could affect clinic access to compounded drugs and how they are obtained and administered.
  • Enforcement burden: Board will need resources to implement and regulate new requirements.

Legislative status & timeline highlights

  • 01/16/2025: Filed (Senate Docket No. 1379)
  • 01/10/2025–02/27/2025: Referred to various committees (Environmental Conservation; Public Health)
  • 04/10/2025: Introduced in Senate; read twice; referred to Committee on Energy and Natural Resources
  • 05/28/2025: Reported and committed to Finance
  • 06/11/2025: Hearing scheduled (A‑1, 1:00–5:00 PM)

For questions about implementation, stakeholders may monitor rulemaking by the Board of Registration in Pharmacy and look for agency guidance once the bill advances.

Compiled from official sources — confirm details with the bill’s official record.

Sign in to ask a question.