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S 3068

An Act protecting patient safety regarding non-FDA approved drugs

194th Legislature (2025-2026)

Regulates compounded drugs to prevent resale, requiring enhanced labeling, traceability, and strict dispensing only to the original patient, with enforcement.

Referred to the committee on Senate Ways and Means
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Bill Summary · S 3068

Overview

  • Bill: S. 3068 (Senate) of the 194th Massachusetts General Court (2025-2026)
  • Title: An Act protecting patient safety regarding non-FDA approved drugs
  • Purpose: Establish clearer rules and penalties related to compounded medications and the resale/distribution of compounded or repackaged drugs, with an emphasis on tracking, labeling, and restricting resale to ensure patient safety. Includes veterinary exemptions and state regulatory enforcement tools.

Main purpose and intent

  • To protect patient safety by regulating compounded medications and preventing improper resale or distribution of compounded drugs by retail pharmacies.
  • To ensure transparency in labeling, traceability (lot/batch numbers), and proper handling of compounded drugs.
  • To restrict the sale or transfer of compounded drugs to entities other than the outsourcing facility that prepared/repackaged them, with limited exceptions.

Key provisions and changes

  • Definitions added:
    • Compounded medication: prepared or modified by a licensed pharmacist to meet an individual patient’s prescription.
    • Retail pharmacy: licensed establishment dispensing prescription meds directly to patients.
    • Resale: selling or transferring a compounded medication from a retail pharmacy to an entity or individual not the original patient.
  • Prohibition on resale:
    • Retail pharmacies may not resell compounded medications.
    • Compounded medications prepared by a retail pharmacy must be dispensed only to the patient for whom they were originally compounded (per prescription).
  • Sanctions:
    • Violations can lead to disciplinary actions by the Board of Registration in Pharmacy (e.g., fines, suspension, revocation of license).
  • Not-for-resale labeling:
    • Drugs labeled “not for resale” cannot be resold.
  • Enhanced labeling and information requirements (for outsourcing facilities):
    • Labels must include:
    • Outsourcing facility name, address, and phone number.
    • For the compounded drug: lot/batch number, dosage form and strength, quantity/volume, expiration date, storage/handling instructions, and National Drug Code (if available).
    • Statements: “not for resale”; if distributed without an individual prescription, “office use only.”
    • List of active and inactive ingredients with quantities.
  • Container labeling:
    • Containers from which units are dispensed must list active/inactive ingredients with quantities.
  • Distribution restrictions:
    • No compounded or repackaged drug may be sold or transferred by anyone other than the outsourcing facility that prepared/repackaged it (with an exception for administration in a health care setting or dispensing by an outsourcing facility pursuant to a proper prescription).
  • Office-use-only provision:
    • Compounded drugs labeled “office use only” must be administered in the office and not dispensed to patients.
  • Veterinary exemption:
    • Use of compounded medications in veterinary practice is exempt from these provisions.
  • Enforcement and rulemaking:
    • Board of Registration in Pharmacy empowered to enforce the act.
    • Bureau of Health Professions Licensure may promulgate rules and regulations for implementation and enforcement.

Who/what is affected

  • Retail pharmacies that compound medications or handle compounded medications.
  • Outsourcing facilities involved in compounding or repackaging drugs.
  • Health care providers and patients receiving compounded medications from retail pharmacies.
  • Veterinary practices (exemption applies).
  • Regulatory bodies: Board of Registration in Pharmacy; Bureau of Health Professions Licensure (for rulemaking).

Procedural/timeline aspects

  • Legislative history indicates:
    • The committee on Health Care Financing reported the bill with an amendment substituting a new draft (Senate, No. 3068) on May 26, 2026.
    • Referred to the Senate Ways and Means committee for further consideration.
  • Effective dates are not specified in the text provided; if enacted, implementation would follow subsequent regulatory rulemaking by the Bureau and enforcement practices by the Board.

Practical impact

  • Stricter controls on resale of compounded drugs, reducing the risk of improper distribution or misuse.
  • Enhanced traceability and labeling requirements to improve patient safety and accountability.
  • Clearer enforcement pathways for regulatory bodies, potentially increasing compliance monitoring of pharmacies and outsourcing facilities.
  • Limited flexibility for office-use-only compounded drugs, ensuring patient-centered dispensing.
  • Maintains veterinary exemption, preserving current practice in animal health without additional regulatory burdens.

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

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