In the wake of the fungal meningitis outbreak, emergency regulations have been implemented in Massachusetts and Florida, rules have been changed in Mississippi, and draft legislation has been introduced in New Jersey.
Many hearings at the state level are scheduled, and many boards have scheduled meetings and begun discussions as a result of the outbreak linked to the New England Compounding Center (NECC) facility, according to Rebecca P. Snead, Executive Vice President & CEO, National Alliance of State Pharmacy Associations (NASPA). NASPA is tracking state-level actions.
Meanwhile, the International Academy of Compounding Pharmacists (IACP) has developed recommendations for states, and FDA is talking with the states about federal and state roles in regulating compounding pharmacy.
These regulations require pharmacies that do sterile compounding to provide reports to the state board, including the number of prescriptions dispensed, states where the prescriptions were distributed, and the status of nonresident licenses and certifications. According to the regs (which refer to pharmacy broadly and not to specifically who at the pharmacy), all reports shall be accompanied by an affidavit attesting compliance with all laws and regulations pertinent to sterile compounding, and that the registrant/licensee only prepares and dispenses pursuant to a valid prescription for a single patient, regardless of whether the medication is prepared for a Massachusetts or out-of-state patient. Pharmacies are required to report all adverse events to the board of pharmacy within 7 business days.
The New Jersey draft legislation, introduced October 15, requires compounding pharmacies to be accredited by the Pharmacy Compounding Accreditation Board, of which APhA is a member. A companion bill related to compounding certification has been prefiled.
Florida has emergency regulations for immediate notification to its board of pharmacy of a compounding pharmacy’s activities, effective November 27 and expiring February 24, 2013.
Mississippi adopted rule changes to its Good Compounding Guidelines/Good Compounding Practices in the areas of compounding guidelines (page 266) and wholesaler/manufacturer permits (page 270), effective January 1, 2013. Among the several changes are the addition of a provision—“No compounding and manufacturing shall take place at the same location”—in the first area, and the addition of language—“Permits issued to any wholesaler/manufacturer facility become null and void sixty (60) days from the date of issuance if inspection reveals a lack of legitimate business activity”—in the second area.
IACP will formally announce and share a list of state practice act change recommendations during a national town hall teleconference with IACP members on December 6, according to David G. Miller, BSPharm, IACP Executive Vice President and CEO.
On December 19 at 3:00 pm, FDA will hold a public meeting on a Framework for Pharmacy Compounding: State and Federal Roles. <http://www.ofr.gov/OFRUpload/OFRData/2012-28786_PI.pdf> At the 2-hour meeting on the agency’s White Oak Campus in Silver Spring, MD, which will also be webcast live, <https://collaboration.fda.gov/pharmacycompounding> FDA will share with stakeholders the results of a previously held intergovernmental meeting to which representatives from the 50 states have been invited.