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09/10/2014

Pharmacy board creates guidance documents for prescribers

The Ohio State Board of Pharmacy has adopted several rule changes that will impact a number of health care professionals. In order to assist with implementation of these rule changes, the Board has created the following guidance documents:

Prescribing Opioids to Minors

Effective September 17, 2014, HB 314 requires all prescribers (physicians, physician assistants, advance nurse practitioners, optometrists, dentists and podiatrists) to obtain explicit informed consent, in the absence of a medical emergency or other specified circumstances, if they intend to prescribe to minors controlled substances containing opioids.

Rescheduling of Hydrocodone Combination Products

Effective October 6, 2014, all hydrocodone combination products (HCPs) will be classified as schedule II controlled substances pursuant to a rule adopted by the United States Drug Enforcement Administration (D.E.A.) on August 22, 2014.

Controlled Substance Inventory Rule Change

Effective January 1, 2015, Ohio Administrative Code Rule 4729-9-14 requires each prescriber or terminal distributor of dangerous drugs to take inventory of all stocks of controlled substances on hand every year following the date on which the initial inventory is taken. This is a change from the previous version of the rule that required a controlled substance inventory every two years.

Drugs Compounded in a Pharmacy Must Adhere to the U.S. Pharmacopeial Convention Chapters 795 & 797

Effective January 1, 2015, Ohio Administrative Code Rule 4729-9-21 requires drugs compounded in a pharmacy to adhere to U.S. Pharmacopeial Convention (USP) Chapters 797 for sterile compounded and 795 for non-sterile compounded drugs. Additionally, all compounded prescriptions must also adhere to section 503A of the Federal Food, Drug and Cosmetic Act.

New Responsible Person Requirements for Pain Management Clinics

Effective April 1, 2015, Ohio Administrative Code Rule 4729-5-11 requires the responsible person for a pain management clinic to be a physician that meets certain requirements (i.e. board certification). In addition the rule was changed to prohibit a physician from being the responsible person for more than one pain management clinic location unless they have been granted a waiver by the Board of Pharmacy.

 

Source: Ohio Hospital Association

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