The Massachusetts Board of Pharmacy (BOP) enacted emergency regulations effective November 1, 2012, in response to the deadly fungal meningitis outbreak caused by drug contamination at a Massachusetts compounding pharmacy.1 Most significantly, the regulations require pharmacies to report extensive data to the BOP regarding their compounding activities. In addition, the regulations implemented new reporting obligations that affect all registered pharmacies and pharmacists in the state and granted the BOP greater authority to quickly shut down pharmacies and quarantine products in the event of immediate public health and safety concerns.
Reporting on Sterile Compounding Activity
The emergency regulations require all licensed pharmacies that perform central intravenous admixture services (CIVAS) or sterile compounding to submit the following information to BOP every six months:
the total number of prescriptions dispensed
distribution data identifying the states in which the prescriptions were distributed
the status of any non-resident licenses issued by other states
clean room hood certifications required by Massachusetts regulations
status of CIVAS approvals where applicable
Pharmacies submitting this information must include an affidavit attesting to compliance with all laws and regulations related to sterile compounding. This attestation requires that pharmacies only prepare and dispense medication pursuant to a valid prescription for a single patient, indicating the BOP's concern that compounding pharmacies have been mass-producing medications similar to pharmaceutical manufacturers, which is potentially in violation of state licensure requirements.
Reporting of Disciplinary Actions and Change in Accreditation Status
All pharmacies and pharmacists registered or licensed in Massachusetts must report to the BOP all "non-routine notices, correspondence and disciplinary actions" within seven business days of receipt. These disciplinary actions include, but are not limited to:
the revocation, suspension, probation, censure, reprimand or restriction of a license to operate a pharmacy or practice pharmacy
the denial of an application for the renewal of a pharmacy license
the denial or restriction of privileges to practice pharmacy
termination from Medicare or state Medicaid programs
adverse actions or fines imposed by any state or federal agency
Pharmacies and pharmacists must also report any adverse change in status of accreditation within seven business days. The new regulations also require every pharmacy and pharmacist to provide the BOP with any responsive documents the pharmacy or pharmacist submitted to a government agency in connection with an event listed above.
Reporting Adverse Events
All pharmacies must now report within seven business days all adverse events relating to the preparation of medication in the pharmacy. Regulations previously required the reporting only of improper dispensing of prescriptions which result in serious injury or death. In addition, pharmacies must report any abnormal results, including the failure to be certified to operate a pharmacy in the state, and identification of any environmental contaminants in the pharmacy.
Cease and Desist and Quarantine Authority
The BOP also may impose a summary cease and desist notice before a hearing takes place in order to stop or to restrict operations "to immediately protect the public health, safety or welfare." Similarly, the board may issue a summary quarantine of products prior to a hearing in order to prevent the use of medications prepared by or in possession of a registered or licensed pharmacy for safety reasons. These orders remain in effect until rescinded by the board or until the board issues a final decision. A hearing must be granted to the registered or licensed pharmacy within 21 days of the board action.
While these emergency regulations are effective immediately, the Massachusetts BOP has granted a 90-day comment period, including a public hearing, to consider changes before taking a final vote.
Impact of Regulations
These regulations will provide the Massachusetts BOP with significantly more data on the activities of licensed pharmacies and will likely result in additional inquiries into these activities. Compounding pharmacies should expect BOP to scrutinize the scope, volume, and nature of compounding activities both inside and outside of the Commonwealth. Moreover, all pharmacies and pharmacists should be aware that BOP now has the ability to monitor adverse actions against their licensure or certification in all states.
We will continue to monitor the impact of these emergency regulations on Massachusetts-licensed pharmacies as well as other upcoming regulatory developments concerning pharmacy compounding in Massachusetts and other states.