State of Ohio Board of Pharmacy: New Compounding Rules Effective 5-1-16

Early last year, the State of Ohio Board of Pharmacy (BOP) announced they would be making changes to compounding rules. The BOP’s goal was to create regulations intended to protect consumers through greater detail and increased consistency with the U.S. Pharmacopeial Convention (USP), a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients and dietary supplements that are manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration.

The new rules cover Terminal Distributor of Dangerous Drugs, Dangerous Drugs, Hazardous Drugs, New Physician Office Requirements, and Immediate Use Provision/Exception.

New Physician Office Requirements

Physicians who compound drugs in their offices must now adhere to strict USP standards, which dictate clean room technology, laminar flow technology and quality assurance techniques. These physicians need to carefully review the new rules to determine if any physical office changes and staff protocols must now be implemented.

Immediate Use Provision/Exception

The “immediate-use” provision in USP is intended only for those situations where there is a need for emergency or immediate patient administration of a compounded sterile product (CSP). Immediate-use CSPs are not intended for storage for anticipated needs or batch compounding and are exempt from many of the USP requirements, including environmental controls, when certain criteria are met. Among other requirements, to qualify for immediate use, administration of the compounded drug must begin no later than 1 hour following the start of the preparation of the compounded drug. 

For more information on these new rules, click here.


**UPDATE** - The BOP has issued and adopted a new resolution.

The pharmacy board was informed by a number of prescribers that they were unaware of the need to obtain a terminal distributor of dangerous drugs license if they were compounding drugs on-site or ordering compounded drugs to their offices. This requirement (ORC 4729.541) impacts all prescriber practices that were previously exempted from licensure, including those who are engaged in reconstitution (vaccines are included in this practice).

So, in recognition that enforcing this new rule as of May 1 would disrupt patient care, the BOP is using its authority under Section 4729.25 of the Ohio Revised Code to grant an extension to all prescribers who are performing drug compounding (including reconstitution) or ordering compounded drugs to their offices from the requirement to obtain a terminal distributor of dangerous drugs license. This extension is hereby valid until September 1, 2016.

For more information on this resolution, click here.   

The Pollen Line is now closed. See you in the spring!

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