Massachusetts Bill Creates New Challenges for Compounding Pharmacies

Massachusetts law makers approved a bill giving regulators unprecedented oversight of the drug compounding industry and creating new obligations for drug compounders doing business in the State. The legislation establishes four new categories of licenses (a retail sterile compounding pharmacy license, a retail complex non-sterile pharmacy compounding license, an institutional sterile compounding license, and a nonresident pharmacy license) and imposes new reporting obligations and required quality assurance measures.

This bill seeks to close the gaps that contributed to the meningitis outbreak from contaminated steroids produced at New England Compounding Center. Applicable to all pharmacies across the country, under the proposed legislation, the Board of Pharmacy will begin regulating out-of-state pharmacies that ship into the State. Additionally, compounding pharmacies will be required to report all prescriptions dispensed within and outside the State to the Board on an annual basis. The bill imposes new continuing education and training requirements for pharmacists engaged in compounding and establishes new labeling requirements for compounded drugs.

Pharmacies can expect an increase in audits and stiff penalties for noncompliance. The bill authorizes the board to suspend or refuse to renew a pharmacy license, without holding a hearing, if there is reasonable concern for the health, safety, or welfare of the public. Pharmacies will face fines up to $25,000 per violation and up to $1,000 for each day a violation continues after the date it should have been corrected.

This new legislation arguably creates the strictest regulations for compounding pharmacies of any State. Compounding pharmacies, even those located in other States but delivering into Massachusetts, should be familiar with the new requirements for doing business in Massachusetts and prepare to implement required changes. Contact Frier Levitt to speak to an attorney.

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