Following an enormous amount of pushback from physician organizations, the State of Ohio Board of Pharmacy (SOBP) has revised its proposed compounding rules and submitted them to the Common Sense Initiative for further examination. The deadline for supplying additional feedback and comment is Friday, medicine August 5.
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.
- 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.
View a copy of the .
In evaluating the cost of rule implementation, the SOBP submitted the following:
Overall this rule will result in increased costs to prescribers that prepare compounded drugs that are not for immediate use. The major cost incurred is the purchase of an ISO 5 hood, which can cost up to $6,000. Additional costs include equipment to maintain an aseptic environment such as gloves, masks, gowns, head and shoe covers. Additional costs also include staff time for training personnel in proper compounding techniques, cleaning and disinfecting compounding areas and ensuring compliance with the rule. While not a direct result of the rule, it does state that any prescriber compounding drugs must obtain a terminal distributor of dangerous drugs. The cost of a terminal distributor license ranges from $112.50 –$150 per year based on the types of drugs stored at that facility. However, there is a planned reduction in this fee to $60 for solo practitioners and smaller practices effective April 2017. The time it takes to complete an application is approximately 30 minutes.
Prescribers who are engaged in immediate-use compounding only will not be required to purchase of an ISO 5 hood. However, prescribers who normally keep single-use vials (for potential use on other patients) for more than 6-hours will experience an increase as a result of having to discard the medication and use a new vial. In addition, prescribers who wish to use a single dose vial for up to 6-hours will have to do so utilizing a closed system transfer device. Such devices cost approximately $2-3 per vial (cost estimates provided by a health system) based on the prescriber’s purchasing contract. Prescribers will also be required to prepare drugs using aseptic technique which will require, at minimum, the use of gloves and proper hand hygiene. Additional costs also include staff time for training personnel in proper compounding techniques, cleaning and disinfecting compounding areas and ensuring compliance with the rule. While not a direct result of the rule, it does state that any prescriber compounding drugs must obtain a terminal distributor of dangerous drugs. The cost of a terminal distributor license ranges from $112.50 –$150 per year based on the types of drugs stored at that facility. However, there is a planned reduction in this fee to $60 for solo practitioners and smaller practices effective in April 2017. The time it takes to complete an application is approximately 30 minutes.
This does not seem to adequately address our problems with the proposed rules.