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Sunday, May 18, 2014

Ohio Board of Pharmacy Proposed Rule Requiring drug compounded in a pharmacy to meet national standards as well as all requirements of federal law



5/16/14



The following information is being provided pursuant to the requirements of Executive Order 2011-01K and Senate Bill 2 of the 129th General Assembly, which require state agencies, including the Ohio State Board of Pharmacy, to draft rules in collaboration with stakeholders, assess and justify an adverse impact on the business community (as defined by S.B. 2), and provide an opportunity for the affected public to provide input on the following rule.

Proposed Rule Change



4729-6-01: Changes references from the Ohio Department of Alcohol and Drug Addiction Services to the Ohio Department of Mental Health and Addiction Services.
• 4729-6-03: Changes references from the Ohio Department of Alcohol and Drug Addiction Services to the Ohio Department of Mental Health and Addiction Services.
• 4729-7-06 (5-Year Review): Changes the requirement that in-state continuing education providers submit their participant lists to the Board. Instead, providers will be required to maintain those records. In addition, in-state providers will no longer have to send notification to the Board before or within fourteen days after a program has been presented.
• 4729-9-21: Requires drugs compounded in a pharmacy to meet national standards as well as meet all requirements of federal law.
• 4729-9-26 (5-Year Review): Corrects a typo in the criminal records check for pain management clinics section of the OAC.
• 4729-9-14 (5-Year Review): Updates references to measurement standards. In addition, requires all prescribers or terminal distributor of dangerous drugs who store controlled substances to conduct an inventory of these drugs annually to detect for theft or diversion.

You can view the proposed rules below.



Comments on the proposed rules will be accepted until close of business on May 30, 2014. Please send all comments to the following email address:

Cameron.mcnamee@bop.ohio.gov


In addition, please copy your comments to:

CSIPublicComments@governor.ohio.gov

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