On December 11, the Joint Committee for Review of Administrative Rules (JCRAR) unanimously approved a motion to request the Pharmacy Examining Board (PEB) consider modifications to the Pharmacy Board Chapter 15 (Phar 15), relating to compounding pharmaceuticals. The Committee voted on the motion after hearing testimony from Bob Van Meeteren, CEO, Reedsburg Area Medical Center and Carl Selvick, senior director clinical services, Fort HealthCare, along with Ann Zenk, WHA vice president, workforce and clinical practice, to align Wisconsin’s compounding pharmaceutical regulations with national standards.
At issue is a draft rule from the PEB for pharmacies that compound. A licensed pharmacist compounds a pharmaceutical preparation—a drug—to meet the unique needs of an individual patient when a commercially manufactured drug is not available to meet those needs.
“While we appreciate the PEB’s intention to reconcile the two, the reality is the current Phar 15 draft is not in sync with United States Pharmacopeia’s (USP’s) national compounding standards, and the state’s regulations will not stay in sync because USP standards will be updated in the future and then state regulations will take several years to update—creating two conflicting and diverging standards,” Zenk told the JCRAR members in her testimony.
Van Meeteren also provided testimony. “Aside from the numerous regulations that our pharmacies and pharmacists are required to follow, as a hospital administrator I fear that the Phar 15 regulations may become our next DHS 124 where state rules on compounding drugs become (in the words of a report from the Walker administration) ‘outdated, duplicative and confusing for health care operators,’” Van Meeteren said. “Requiring the Phar 15 rules to align with USP 797 removes additional time and burden for our pharmacists and removes added and unnecessary cost from the system.”
Selvick, a pharmacist and the director in charge of Fort HealthCare’s pharmacy services, agreed with Zenk and Van Meeteren that aligning state and national standards makes sense.
“Hospital pharmacies rely on the USP as the industry standard to continually ensure safe and effective pharmacy practice.” Selvick noted, “Compounding drugs in our pharmacies is a process that we take very seriously, and I agree 100 percent with what the pharmacy board is aiming for; we just want them to hear that they have not yet reached that aim.”
WHA, the Rural Wisconsin Health Cooperative and the Pharmacy Society of Wisconsin are among the stakeholders that have shared feedback with the PEB about Phar 15. Zenk called the JCRAR request for modification “an opportunity to prevent state regulations from becoming stale and confusing for highly regulated hospitals and pharmacies.”
The PEB has until December 26, 2017 to respond to this request for rule modification. For additional information about Phar 15 and USP alignment efforts, contact Ann Zenk at email@example.com or 608-274-1820.