An Act protecting patient safety regarding non-FDA approved drugs
By Mr. Cronin, a petition (accompanied by bill, Senate, No. 1497) of John J. Cronin for legislation to protect patient safety regarding non-FDA approved drugs. Public Health.
Bill Information
Bill Information
- Presenter:
- John J. Cronin
- Status:
- Referred to Joint Committee on Health Care Financing
This bill regulates the sale and distribution of compounded medications by retail pharmacies, mandating that such medications be dispensed solely to the patient for whom they were originally compounded, based on a valid prescription, and prohibiting their resale. Violations can lead to disciplinary actions, including fines or license suspension/revocation by the state's Board of Registration in Pharmacy. The bill also imposes labeling requirements for compounded drugs from outsourcing facilities, which must indicate the drug is compounded, provide the facility’s contact information, and include details like lot number, dosage form, expiration date, and storage instructions. Drugs marked "not for resale" are restricted to healthcare or office settings for administration and cannot be dispensed directly to patients. The Board is empowered to enforce these regulations and may establish additional rules to effectively implement the bill's provisions. A severability clause ensures that if any part of the bill is invalidated, the remaining provisions remain effective.
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