The International Academy of Compounding Pharmacists (IACP) represents more than 4,000 pharmacists, technicians, students, and members of the compounding community who focus on the specialty practice of pharmacy compounding. Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose health care needs cannot be met by manufactured medications. IACP works diligently to preserve patient access to these vital compounded medications.
IACP would like to thank the Kansas Board of Pharmacy for this opportunity to present thoughts on the proposed K.A.R.
68-13-2, 68-13-3, and 68-13-4 (Proposed Regulations). IACP supports the Kansas Board of Pharmacy's mission to ensure that patients throughout the State of Kansas receive safe, effective and quality compounded medications. IACP understands and supports the need to protect public health. When developing and implementing regulations, it is essential to preserve patient access to vital compounded medications, the prescriber-patient pharmacist triad, and the right of a patient to choose their pharmacist. Prescribers must have the right to prescribe medications that best fit the needs of their patients.
IACP has reviewed the Proposed Regulations and would like to provide the following stakeholder input. IACP has heard from pharmacists as well as prescribers who will be impacted by the Proposed Regulations when compiling this input.
First, IACP commends the Board for recognizing the need for pharmacists to provide both sterile and nonsterile compounds to prescribers for office-use. Pharmacists' ability to provide compounded medication for prescribers to use within their practice setting is critical to patient care.
Second, while IACP supports the Board's intent to create compounding standards consistent with U.S. Pharmacopeia (USP) requirements, IACP is concerned that certain portions of the Proposed Regulations are inconsistent with current standards found within USP General Chapters <795> and <797>, such as:
- Defining terms or compounding categories within K.A.R. 68-13-2 that either do not exist within <795> and <797> or conflict with the current USP definitions.
- Imposing restrictions on the use of compounding ingredients within K.A.R. 68-13-3 which currently do not exist with <795> and <797>.
- Creating beyond use dating requirements within K.A.R. 68-13-3 and 68-13-4 that are unclear and potentially more restrictive than those found in <795> and <797>.
- Establishing sterile compounding risk categories within K.A.R. 68-13-4 that conflict with each other and are inconsistent with those established within <797>.
In order to best preserve patient access to vital compounded medications, IACP urges the Board to make revisions to specific sections of the Proposed Regulations (see attached), along with the remainder of K.A.R. 68-13-2, 68-13-3, and 68-13-4 to align the Proposed Regulations with the current standards found within USP <795> and <797>.
IACP appreciates the opportunity to present its perspective to the Kansas Board of Pharmacy and is available to answer any questions the Board may have. IACP looks forward to any opportunity to work with the Board regarding this or any other matter to achieve the mutual goal of protecting and promoting the health and safety of Kansans through continued access to high quality compounded medication. Read the entire letter
