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PRACTICE QUESTIONS

Controlled Substance Registrations for a pharmacy are valid for:

A. Two years beginning January 1st of even-numbered year

B. One year beginning January 1st of even-numbered year

C. Two years beginning December 31st of odd-numbered year

D. One year beginning December 31st of odd-numbered year

E. One year beginning December 1st of each year

A. "Two years beginning January 1st of even-numbered year"

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.

Controlled Substance Registrations for wholesale drug businesses are valid for:

A. Two years beginning January 1st of even-numbered year

B. One year beginning January 1st of even-numbered year

C. Two years beginning December 31st of odd-numbered year

D. One year beginning December 31st of odd-numbered year

E....

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