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The Kentucky Board of Pharmacy (Board) recently promulgated a significant regulatory update that will affect compounding practices throughout the Commonwealth. Section 9 of the newly adopted regulation establishes a timeline for the enforcement of the 2022 revisions to United States Pharmacopeia (USP) Chapters 795, 797 and 800. It is essential for pharmacists and pharmacy owners to understand these changes, as they present both new compliance responsibilities and opportunities to enhance patient care.
Delayed Enforcement of New USP Standards:
Starting January 1, 2026, the Board will enforce the 2022 revisions to USP Chapters 795 (nonsterile compounding), 797 (sterile compounding) and 800 (hazardous drugs). Until then, pharmacies must comply with the 2014 version of USP 795 and the 2008 version of USP 797. Permit holders may request inspection under the new 2022 standards if they wish to transition early.
Highlights of the USP 2022 Standards Include:
- The addition of the Designated Person (definition and responsibilities).
- Definitions for "essential copy of a commercially available drug product" and "hazardous drug" and rules regarding both terms.
- The addition of a flavoring will not be considered compounding if the additive is non-expired, inert, nonallergenic, produces no effect other than the instillation or modification of flavor and is not greater than five (5) percent of the drug product's total volume.
- The dispensing of compounded preparations for veterinary use shall follow the requirements of 201 KAR 2:311.
Verification of a compounded preparation shall be completed by a pharmacist after the preparation of the compound and prior to dispensing to the patient.
What Does This Mean for Pharmacies?
More Time to Prepare
- Pharmacies have until 2026 to update facilities, train staff and implement protocols for the more stringent 2022 USP standards. With the approaching effective date, pharmacies and pharmacists must prepare to comply with the 2022 USP standards.
Early Adopter Advantage
- For those ready to lead, you can request inspection under the 2022 standards before the deadline. This positions your pharmacy as a pioneer in safety and compliance, which can be a powerful marketing point to patients and partners.
No USP 800 Burden—Yet
- USP 800, which governs hazardous drug handling, won't be enforced until 2026. This is a new requirement for Kentucky pharmacies and pharmacists should prepare to plan investments in containment, ventilation and PPE.
What Should Pharmacies Do Next?
Assess Your Readiness:
- Review your current compounding and sterile preparation practices. Identify gaps with the upcoming 2022 standards and make a plan to address them before 2026.
Train Your Team:
- Pharmacies should educate their staff on the current standards and what's coming, so the pharmacies are ready for the transition.
Conclusion:
In summary, the Kentucky Board of Pharmacy's recent rule change provides pharmacies with a defined timeline to transition to the updated USP standards. By proactively preparing for these regulatory changes and leveraging the permitted exceptions, pharmacies can ensure continued compliance, maintain operational efficiency and enhance the quality of care provided to patients. Pharmacies are encouraged to review their current procedures, educate their staff and seek professional guidance as needed to navigate these developments successfully and position themselves as leaders within the evolving regulatory environment.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
