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QUICK REVIEW AND RECAP OF SECTION 247 CMR

247 CMR Section 11 – Registration under the Controlled Substances Act

A pharmacy, outsourcing facility, and a wholesale drug business may register to manufacture, distribute, or dispense controlled substances.

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Type of establishment Length of license validation Renewal date of license
Pharmacy 2 years beginning January 1st of each even-numbered year December 31st on each odd-numbered year
Outsourcing facility 2 years beginning January 1st of each even-numbered year December 31st on each odd-numbered year
Wholesale druggist Every year beginning December 1st November 30st every year

Considerations for an applicant

  • ✓ Ability to prevent diversion

  • ✓ Compliance with federal and state laws

  • ✓ Previous convictions

  • ✓ Previous experience in manufacturing or distributing controlled substances

  • ✓ Potential false information provided in the application

General information

14 days

to notify the Board and DEA about changes in the name and/or address

  • A separate registration is needed for each place of business where the person manufactures, distributes, or dispenses.

  • A wholesale drug business is only authorized to distribute the controlled substance or the class of controlled substances the business registered for.

  • The registration becomes invalid when the business ceases to exist, was sold to another owner, or if the name/address changes (the Board and US DEA must be notified within 14 days of the change).

  • Registration cannot be transferred; the owner must re-apply (and will be treated as a first-time applicant).

Criminal Activities

  • If criminal activities occur, the Board should send the evidence ("pertinent facts") to the district attorney in the country or to the attorney general.

  • If a license is suspended or revoked, the substances are under embargo and may be forfeited to the Commonwealth (as well as the DEA being notified).

  • A hearing may not take place in order to revoke or suspend a license (in other words, the Board may decide what to do without hearing what the registrant has to say).

Summary Suspension

In the event of a suspension of license:

  1. The establishment must shut down and must conduct the following:

    • ✓ Replace the locks on all the doors

    • ✓ Place a sign (letters no less than 1" in height and 1" wide) that shall say, "The registration of this establishment has been suspended by the Order of the Massachusetts Board of Registration in Pharmacy".

    • ✓ Take inventory of all drugs

  2. An Order of Suspension + Notice of Hearing is sent to the owner of the establishment or the pharmacy's Manager of Record. The suspension takes place until the final hearing.

  3. A hearing takes place within 7 days after the order of suspension to determine whether the summary suspension shall continue. The registrant will ...

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