- Reconstituting per manufacturer’s instructions will no longer be considered compounding
- Buffering with Lidocaine or other anesthetic agents will not be subject to the rules
- The rule would still contain an immediate use provision – there was some discussion regarding whether provision would stay 1hr/6hr or change
- Physicians who qualified for the terminal distributor of dangerous drugs (TDDD) solo exemption would still qualify as long as they were only reconstituting and/or buffering with anesthetic agents.
Please understand that we have not seen these revisions on paper but as soon as we confirm the specific language contained in the rule redraft, we will provide additional information via the Weekly Family Medicine Update.
The OAFP’s initial comments focused on immediate use vaccine provisions which were so restrictive that primary care practices could have been driven completely out of the immunization business. Our second round of comments focused on the overreach of the proposed rules and the regulatory burden placed on physician practices which in many cases are small businesses.
“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.”
“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. The USP Chapter 797 governing Pharmaceutical Compounding—Sterile Preparations is currently undergoing a review. USP is expected to release a draft this fall with the potential for additional stakeholder comments. It is working with the leading scientists, physicians and other 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.”