Pharmaceutical Firms Enforcement Process
The Pharmacy Quality Assurance Commission is changing its procedure for enforcement action against pharmaceutical firms*.
In 2009 a determination made in the Court of Appeals of Washington, Division 1, in Seymour DDS v. Washington State Department of Health Dental Quality Assurance Commission (DQAC) found that the authority to launch an investigation belongs to DQAC. After the ruling, all boards and commissions changed their process to a three-member board/commission panel to authorize and charge under the Uniform Disciplinary Act chapter 18.130 RCW.
The interpretation at that time extended the panel of three commission members under the UDA to authorize and charge pharmaceutical firms licensed and disciplined under the authority of the Pharmacy Quality Assurance Commission.
In August of 2017, the Pharmacy Commission was advised that using the APA for pharmaceutical firm enforcement more closely reflects the language of the governing statutes.
The commission has requested transparency in implementing the change, and to inform stakeholders by developing a communication plan and posting the procedure on the Internet.
The commission will use the Administrative Procedure Act (APA), RCW 34.05, when taking enforcement action against a pharmaceutical firm. This allows a quorum of the commission (minimum of eight (8) members) to pursue enforcement action in cases involving a pharmaceutical firm. The commission will continue to use the Uniform Disciplinary Act (UDA), RCW 18.130, for enforcement action in cases related to the credential of an individual licensee. The UDA allows the use of a three (3)-member panel.
The Pharmacy Quality Assurance Commission regulates the practice of pharmacy, and the distribution, manufacturing, and delivery of pharmaceuticals within and into the state. The commission protects and promotes public health and safety by responding to complaints or reports of unprofessional conduct or law and rule violations. When the commission receives a complaint or report of a violation, it has a process to determine whether the complaint or report warrants investigation and then whether the outcome of the investigation warrants enforcement action. The charts that follow outline the processes that the commission uses when assessing, investigating, and taking enforcement action based on a complaint or report. One chart sets out the process for pharmacists, pharmacy interns, and ancillary staff. The other chart sets out the process for pharmaceutical firm applicants, pharmaceutical firm licensees, or pharmaceutical firm certificate holders.
*Pharmaceutical Firm is defined as applicants or holders of facility licensees or registrations issued to facilities under RCW 18.64 that includes, but is not limited to: pharmacies, manufacturers, wholesalers, nonresident pharmacies, health care entities, and hospital pharmacy-associated clinics.