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INTRODUCTION

247 CMR Section 11:

This section discusses the controlled substances act and requirements needed to obtain and maintain a controlled substance registration. A controlled substance registration is needed by a pharmacy, outsourcing facility, or wholesale drug business if they plan on dealing with controlled substances; however, each of these entities must first be licensed or registered with the Board before getting a controlled substance registration. The table below summarizes expirations and renewal for controlled substance registration:

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Pharmacy Outsourcing Facility Wholesale Drug Business
Expiration Valid for two years beginning January 1st of even-numbered year Valid for two years beginning January 1st of even numbered year Valid for one year beginning December 1st of each year
Renewal Prior to December 31st each odd-numbered year Prior to December 31st each odd-numbered year Prior to November 30th each year

Key things to remember:

  • Separate registrations are needed for each principle place where licensee or registrant manufactures, distributes, or dispenses controlled substances.

  • Controlled substance registrations will terminate if the pharmacy, outsourcing facility, or wholesale drug business a) no longer exists, b) has a name/address change or c) is sold.

    • If there is a name/address change, a new application is needed.

  • Board must be notified within 14 days if any of above changes occurs

  • Registrations cannot be transferred

  • Registrations can be suspended or revoked by the Board for violations including criminal convictions, fraudulent information reported on application, etc.

  • The Board has the authority to suspend, revoke, or refuse a registration without a hearing if they feel there is an imminent danger to public health.

247 CMR Section 12:

The Board has the authority to offer registration to restricted pharmacies which may only offer pharmacy services to beneficiaries of a trust, fund, pension plan, combination plan, or profit sharing. Restricted pharmacies:

  • May limit their operation to a specific schedule

  • Will be exempt from 247 CMR 9.01(15), which states a pharmacy cannot limit its services to particular groups of the population.

247 CMR Section 13:

Due to the dangerous nature of nuclear medicine, the Board has made specific regulations concerning nuclear pharmacies. 247 CMR 13.02 goes over definitions (below) that are specific to nuclear pharmacies.

  • Nuclear pharmacy: Facility registered with the Board to dispense radiopharmaceuticals.

  • Qualified nuclear pharmacist: Pharmacist registered by the Board, employed in a nuclear pharmacy who has submitted proper evidence to the Board that he/she is meets education, training, and experience requirements who has also received written approval from the Board.

  • Radiopharmaceutical drug: Substance that exhibits spontaneous disintegration of unstable nuclei with emission of nuclear particles or photons.

In order to receive a nuclear pharmacy permit, there are specific requirements the pharmacy must follow such ...

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