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Bill > S1497


MA S1497

MA S1497
Protecting patient safety regarding non-FDA approved drugs


summary

Introduced
02/27/2025
In Committee
01/07/2026
Crossed Over
Passed
Dead

Introduced Session

194th General Court

Bill Summary

For legislation to protect patient safety regarding non-FDA approved drugs. Public Health.

AI Summary

This bill establishes comprehensive regulations for compounded medications in retail pharmacies to protect patient safety. The legislation defines key terms like "compounded medication" (a prescription medication prepared by a licensed pharmacist for a specific patient's unique needs) and "retail pharmacy" (a licensed establishment that dispenses prescription medications directly to patients). The bill prohibits retail pharmacies from reselling compounded medications, mandating that such medications can only be dispensed to the specific patient for whom they were originally prepared. Additionally, the bill requires detailed labeling for compounded drugs, including information such as lot numbers, ingredient lists, expiration dates, and storage instructions. Outsourcing facilities must include specific labeling elements, such as a statement that the drug is not for resale, and are restricted from selling or transferring compounded drugs except through proper prescription channels or administration in healthcare settings. The state's Board of Registration in Pharmacy will have enforcement authority, with the power to impose disciplinary actions like fines or license suspension for violations. The legislation aims to prevent potential misuse or inappropriate distribution of customized medications and ensure patient safety by creating strict guidelines for compounded drug handling and dispensing.

Committee Categories

Health and Social Services

Sponsors (1)

Last Action

Bill reported favorably by committee and referred to the Joint Committee on Health Care Financing (on 01/07/2026)

bill text


bill summary

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bill summary

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bill summary

Document Type Source Location
State Bill Page https://malegislature.gov/Bills/194/S1497
BillText https://malegislature.gov/Bills/194/S1497.pdf
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