Board of Pharmacy Releases New Hazardous Drug Compounding Rule/Information

At their July meeting, the Ohio Board of Pharmacy voted to retract and redraft the dangerous drug rule (OAC 4729-16-04), and they created a new rule (OAC 4729-16-13) specifically dealing with an immediate-use provision. Prior to the July meeting, the AMCNO signed onto a letter along with several other medical associations outlining our concerns about this rule. To view a copy of the letter click here.

The latest iteration of the rule provides for a more lenient immediate-use time than the USP immediate-use provision.  The draft rule gives providers 6 hours to administer a compounded drug without the need for an ISO 5 environment while USP limits the use to a one-hour time frame. There will be no changes to the hazardous drugs compounding rule (OAC 4729-16-11)—they were in effect as of May 1, 2016; however, the necessity for providers to obtain a Terminal Distributor of Dangerous Drugs license for the purpose of compounding dangerous drugs will be delayed until April 2017.  To view the documents from the Board of Pharmacy on this issue click here and here.   

The new rules now enter the official rules review process where there will be opportunities to comment. A pharmacy board rules hearing will be scheduled within the next few months. The rules have also entered the Common Sense Initiative (CSI) review process. Read on for more information on the CSI comment period:

Rule Package : Drug Compounding

Amended

  • 4729-16-01: Definition section for drug compounding rule chapter. Updates the definition of compounding to include the preparation of sterile and non-sterile compounded drugs.  Updates reference for the definition of hazardous drugs to new section of the United States Pharmacopeia (USP 800).  Includes definition of sterile and non-sterile compounded drugs.  Defines the phrase “licensed personnel approved by the responsible person” as specified in OAC 4729-16-04, 11 and 13.
  • 4729-16-04: Specifies requirements for prescribers who compound drugs. Further defines the responsibility of the responsible person on the terminal distributor license.  Includes new requirements for single-use and multi-use vials. Specifies the requirements for cleaning and disinfecting areas where drugs are compounded. Requires the adherence to aseptic technique when compounding drugs.  References proposed immediate use drug compounding rule 4729-16-13. Permits a registered nurse who prepares a compounded drug to administer the drug.

New

  • 4729-16-13: Specifies requirements for prescribers who compound drugs for immediate-use. Includes requirements for preparing drugs in a clean environment and adherence to aseptic technique to prevent contamination.  The rule also includes time restrictions for the use of drugs opened outside of ISO 5 environment. 

A copy of the business impact analyses can be accessed here: http://www.pharmacy.ohio.gov/LawsRules/ProposedRules.aspx

Comments on the proposed rules will be accepted until close of business on August 5, 2016. 

Please send all comments to the following email address: Cameron.mcnamee@pharmacy.ohio.gov

In addition, please copy your comments to: CSIPublicComments@governor.ohio.gov



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