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Ohio News: New and Revised Rules Have Been Filed
Published in the February 2006 Ohio State Board of Pharmacy Newsletter
The Board filed several new and revised rules that became effective on January 1, 2006. The full text of these rules, showing changes, can be found on the Board’s Web site. Click on “What’s New” and you will find the document with the new rules. Included in these rules are a new chapter dealing with charitable pharmacies (4729-36) and a new chapter dealing with the Prescription Monitoring (drug database) program (4729-37). The next Newsletter will contain specific information about the new Prescription Monitoring program and the ways that pharmacists and prescribers can obtain information about their patients’ prescription histories.
Another rule that was added in 2006 was Rule 4729-9-25 – “Drugs compounded for direct administration by a prescriber.” In 2005, the Legislature revised the definition of “Compounding” in §4729.01(C) of the Pharmacy Practice Act by adding paragraph 5 to allow for the limited supply of a compounded product to a prescriber at his or her office. The new paragraph in the definition of “Compounding” in the Revised Code is as follows:
(C) “Compounding” means the preparation, mixing, assembling, packaging, and labeling of one or more drugs in any of the following circumstances:
(5) Pursuant to a request made by a licensed health professional authorized to prescribe drugs for a drug that is to be used by the professional for the purpose of direct administration to patients in the course of the professional’s practice, if all of the following apply:
(a) At the time the request is made, the drug is not commercially available regardless of the reason that the drug is not available, including the absence of a manufacturer for the drug or the lack of a readily available supply of the drug from a manufacturer.
(b)A limited quantity of the drug is compounded and provided to the professional; and
(c) The drug is compounded and provided to the professional as an occasional exception to the normal practice of dispensing drugs pursuant to patient-specific prescriptions.
The new rule promulgated by the Board defines what a “limited quantity” is and it also defines what constitutes an “occasional exception to the normal practice of dispensing drugs” so that the pharmacy does not end up being charged by Food and Drug Administration or the Board with manufacturing in violation of federal law. If you are a compounding pharmacy, please read this rule very carefully before you begin to provide any products directly to a prescriber’s office.
