Bill

Bill > H2472


MA H2472

MA H2472
Protecting patient safety regarding non-FDA approved drugs


summary

Introduced
02/27/2025
In Committee
02/27/2025
Crossed Over
Passed
Dead

Introduced Session

194th General Court

Bill Summary

Relative to the distribution of compounded medications. Public Health.

AI Summary

This bill addresses the distribution and handling of compounded medications by retail pharmacies, introducing several key provisions to enhance patient safety. The legislation defines compounded medications as prescription drugs prepared by licensed pharmacists to meet individual patient needs, and prohibits retail pharmacies from reselling these medications. Under the bill, compounded medications can only be dispensed to the specific patient for whom they were originally prepared, with strict labeling requirements for outsourcing facilities. These requirements include displaying the drug's lot number, established name, dosage, strength, compounding date, expiration date, storage instructions, and a clear "not for resale" statement. The bill establishes that compounded drugs labeled "office use only" must be administered in a medical office and cannot be dispensed to patients. Violations of these provisions can result in disciplinary actions by the state's Board of Registration in Pharmacy, potentially including fines, license suspension, or revocation. The legislation aims to prevent the inappropriate distribution of customized medications and ensure that these specialized drugs are used safely and exclusively for their intended patients, with the state's pharmacy board empowered to enforce these new regulations.

Committee Categories

Health and Social Services

Sponsors (1)

Last Action

Reporting date extended to Thursday, October 9, 2025 (on 09/11/2025)

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/H2472
BillText https://malegislature.gov/Bills/194/H2472.pdf
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