Following an enormous amount of pushback from physician organizations, the State of Ohio Board of Pharmacy (SOBP) revised its proposed regulations governing the use of compounding of nonhazardous drugs by prescribers in the office setting, Ohio Administrative Code 4729-16-04 and 4729-16-13, submitted them to the Common Sense Initiative (CSI) for further examination. The proposed rule and business impact analysis are available on the .
On August 1, the Ohio Academy of Family Physicians submitted additional comments for the consideration of the CSI. The CSI is an agency created by the Kasich administration to review proposed rules relative to their business impact.
Our comments focused on the overreach of the proposed rules and the regulatory burden placed on physician practices which in many cases are small businesses. The comments state:
“Layers upon layers of regulation are confusing, complex, extremely burdensome, and expensive to implement. Many primary care practices are small businesses that struggle to stay afloat – meeting payroll, paying bills, and keeping the lights on while providing patients with the highest quality care. Increasing the costs of clinical care without correspondingly significant improvement in patient safely just doesn’t make sense. In the materials submitted to the CSI, the SOBP admits to the substantial expense practices will incur to implement these new requirements. Many predict the actual expense will be much more than is documented in the SOBP’s CSI filing.”
Submitted comments continued:
“The U.S. Pharmacopeial Convention (USP) is the leading scientific body responsible for establishing standards for the safe manufacturing, distribution, and consumption of drugs in the United States and worldwide. USP Chapter 797 governing Pharmaceutical Compounding—Sterile Preparations is currently undergoing a review. The USP is expected to release a draft this fall with the potential for additional stakeholder comments. It is working with the leading scientists, health care providers and regulators to revise its standards on compounding and sterile protections. Why would we not wait to see how this review plays out? Why would we not make an effort to make standards align? Inconsistency with federal regulations certainly should not be the desired outcome.”
Earlier comments made by the OAFP caused the SOBP to address concerns about immediate use vaccine provisions which were so restrictive that primary care practices could have been driven completely out of the immunization business. A six hour immediate use provision has been added in the SOBP’s rules submitted to the CSI.
Individual OAFP members who wish can submit comments for consideration of the CSI by sending an email to CSIPublicComments@governor.ohio.gov. The deadline for comments is Friday, August 5.