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News Mandated Reporting Requirements

5/02/2014
  • Board of Registration in Pharmacy

TO: All Pharmacies and Pharmacists

FROM: David Sencabaugh, Executive Director, Board of Registration in Pharmacy

DATE: May 2, 2014

Mandated Reporting Requirements

The regulations require pharmacies to report certain events and circumstances to the Board within specified timeframes.  The reporting requirements are summarized as follows:

Regulation

Event / Circumstance to be Reported

Deadline for Report

Address to Submit Report

247 CMR 6.15(2)

Any non-routine notices

Within 7 business days of receipt

DHPL-OPP.ADMIN@massmail.state.ma.us

247 CMR 6.15(3)

Any adverse change in status of accreditation

Within 7 business days of an action taken by the accrediting agency

DHPL-OPP.ADMIN@massmail.state.ma.us

247 CMR 6.15(6)

All adverse events relating to preparation of medications

Within 7 business days of identification of the error

DHPL-OPP.ADMIN@massmail.state.ma.us

247 CMR 10.03(1)(y)

Discipline resulting from the practice of any licensee

7 days of the disciplinary action

DHPL-OPP.ADMIN@massmail.state.ma.us

247 CMR 10.03(1)(z)

Any final action (i.e., surrender of license, resignation)

7 days of the final action

DHPL-OPP.ADMIN@massmail.state.ma.us

247 CMR 10.03(1)(aa)

Any pending criminal charge or conviction of any licensee

30 days of the charge or conviction

DHPL-OPP.ADMIN@massmail.state.ma.us

247 CMR 6.15(7)

Abnormal results, identification of environmental contaminants, or improper potency, inconsistent with United States Pharmacopeia (USP) General Chapter 797 standards

Within 7 business days of abnormal results

Abnormalresults@state.ma.us

247 CMR 6.02(10)

Loss of controlled substances

Within 7 business days of discovery of the loss

DHPL-OPP.ADMIN@massmail.state.ma.us

247 CMR 6.14 and 15.05

Dispensing errors resulting in death or serious injury

Within 15 business days discovery

DHPL-OPP.ADMIN@massmail.state.ma.us

247 CMR 6.15(5)

Sterile Compounding Bi-annual Reporting

January 15 and July 15 of each calendar year

Kelly.A.Barnes01@state.ma.us

Failure to comply with the reporting requirements or cooperate fully with the Board during any Board investigation of such reports will be grounds for disciplinary action by the Board.

Any questions related to the reporting requirements should be directed to the Board.

All reporting forms required above can be found on the Board website.

Please ensure that you review these forms periodically to make sure that you are using the most up to date form. The Board has recently revised several of the required reporting forms. Specifically, the Board would like to direct your attention to the Loss of Controlled Substances Reporting form, which needs to be submitted to the Board in addition to the DEA Form 106.

Additional Resources for Mandated Reporting Requirements

Board of Registration in Pharmacy 

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