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Board of Pharmacy Rule Changes Effective Now

Several changes in Ohio Administrative Code rules went into effect on August 22, 2014. We thank the OPA members who serve on the State Board’s Rules Review Committee for their contributions. Here is a brief rundown of the major rule changes.

• 4729-3-01: Authorizes the Board of Pharmacy to waive the 2:1 ratio (pharmacy interns:pharmacists) for the operation of immunization clinics or other specific circumstances.

• 4729-5-17: Clarifies that prescriber dispensing limits do not apply in the following instances, as indicated in law: (a) methadone provided to patients for the purpose of treating drug addiction, (b) buprenorphine provided to patients for the purpose of treating drug addiction, (c) controlled substances provided to research subjects by a facility conducting clinical research, (d) and a prescriber who is a veterinarian.

• 4729-5-35: Removes the 100% accuracy requirement for automated drug delivery systems and also provides an appeal process by which a terminal distributor of dangerous drugs can appeal a decision by a Board of Pharmacy inspector.

• 4729-5-38: Authorizes a trained licensed pharmacist to administer the measles, mumps, and rubella (MMR) vaccine to individuals 18 years and older.

• 4729-7-06: Changes the requirement that in-state continuing education providers submit their participant lists to the Board. Instead, CE 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 14 days after a program has been presented. However, providers of law CE are still required to send notice, or a sample of the program or experience certificate to the board no later than 14 days after a program is presented.

•Effective August 18, 2014, tramadol, and products containing tramadol, are classified as Schedule IV controlled substances pursuant to a rule adopted by the United States Drug Enforcement Administration (D.E.A.).

•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 D.E.A. on August 22, 2014. Please note: Cough syrups that contain hydrocodone will also be classified as schedule II controlled substances when this rule takes effect..

•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..

•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..

For more information on these rule changes and how to stay compliant, visit http://www.pharmacy.ohio.gov/.

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