IOWA BOARD OF PHARMACY REGULATORY PLAN FY2017 Chapter # and Title Description of Action, Reason, & Alternatives Legal Basis for Action Schedule for Action Contact Person(s) IAC 657—Chapter 8 Universal Practice Standards Define requirements for prescribing opioid antagonists to fire departments, law enforcement agencies, and others, via prescription and standing order, pursuant to recent legislative directive. SF 2218 as amended by Div. XIV of HF 2460 November 2016 Terry Witkowski or Andrew Funk (515) 281-5944 IAC 657—Chapter 10 Controlled Substances Drug scheduling actions in response to actions taken by the federal DEA. Iowa Code Chapter 124.201 Dependent on federal DEA action Terry Witkowski (515) IAC 657—Chapter 16 Nuclear Pharmacy Practice Convene task force and review rules and Iowa Code requirements relating to nuclear pharmacy practices, including compounding of hazardous drugs; amend as deemed necessary Iowa Code Chapter 155A.13 February 2017 Terry Witkowski or Andrew Funk (515) 281-5944 IAC 657—Chapter 19 Nonresident Pharmacy Licenses Review rules and Iowa Code requirements relating to nonresident pharmacy licenses; amend as deemed necessary; amend to implement legislative changes enacted during 2016 session Iowa Code Chapter 155A.13A as amended by SF 453, Section 4 August 2016 Terry Witkowski or Andrew Funk (515) 281-5944 IAC 657—Chapter 23 Long-Term Care Pharmacy Practice Convene task force and review and amend various rules as needed to reflect changes in federal law, regulations, and guidance and to utilize technology solutions in long-term care facilities Iowa Code Chapter 155A.13 February 2017 Terry Witkowski or Andrew Funk (515) 281-5944 IAC 657—Chapter XX (New) Limited Drug and Device Distributor Licenses Convene task force and define limited drug and device distributors (LDDD). Establish license and practice requirements of businesses not qualified for pharmacy or drug wholesale licensure that engage in the delivery of prescription home health aides and supplies and medical gases. Iowa Code Chapter 155A.33 and 155A.4 August 2016 Terry Witkowski or Andrew Funk (515) 281-5944
IAC 657—Chapter 13 (New) Telepharmacy Practice Define telepharmacy, establish license and practice requirements for the operation of a telepharmacy and for utilization of certified pharmacy technicians in the practice of telepharmacy based on legislative changes enacted during 2016 session Iowa Code Chapter 155A.3, 155A.13, 155A.33, as amended by SF 453, sections 2 and 3 July 2016 Terry Witkowski or Andrew Funk (515) 281-5944 657 IAC— Chapter 10 Controlled Substances Complete review and amendment of rules, as determined appropriate and in conformance with current safe practices and federal constraints, including consideration of the types of businesses and practitioners that are or should be required to register and comply with the Iowa Controlled Substances Act and ensuring that all registrant types are appropriately authorized to handle controlled substances pursuant to the practitioner’s enabling legislation. Iowa Code Chapter 124.301 – part of review of all Board rules January 2016 Terry Witkowski or Andrew Funk (515) 281-5944 657 IAC—Chapter 8 Universal Practice Standards and Chapter 17 Wholesale Drug Licenses Add and amend rules as necessary to implement the provisions of the federal Drug Supply Chain Security Act (DSCSA) relating to Iowa licensed pharmacies and drug wholesalers. Iowa Code Chapter 155A.13, 155A.17, and federal DSCSA, Title II of the 2013 Drug Quality and Security Act, P.L. 113-54 November 2016 Terry Witkowski or Andrew Funk (515) 281-5944
657 IAC – Chapter 41 (New) Outsourcing Facilities Establish new licensure type, outsourcing facility, to license and regulate facilities engaged in sterile compounding of human prescription drug products without patient-specific prescriptions and distributing those sterile products to hospitals, health care facilities, clinics, and prescriber offices, for example, for administration to patients being treated by and in those locations, establishing minimum standards for the licensure and operation of those outsourcing facilities based on legislative authority granted during the 2016 session New Iowa Code section 155A.13C as enacted by SF 453, section 5 August 2016 Terry Witkowski or Andrew Funk (515) 281-5944 657 IAC Chapter 9 Automated Medication Distribution Systems and Telepharmacy Services Review and amend to reflect current and emerging technologies relating to medication distribution and systems and incorporate appropriate provisions regarding telepharmacy practices and services into new Chapter 13, Telepharmacy Practice Iowa Code section 155A.13 as amended by SF 453, section 3 September 2016 Terry Witkowski or Andrew Funk (515) 281-5944 657 IAC Chapter 37 Prescription Monitoring Program Review and amend rules as appropriate to authorize integration of the Iowa PMP with electronic health and pharmacy information systems pursuant to legislative authority granted during the 2016 session Iowa Code sections 124.551 and 124.553 as amended by SF2102 October 2016 Terry Witkowski or Andrew Funk (515) 281-5944 657 IAC Various Chapters Amend various chapters, as needed, to implement provisions regarding criminal history data for individuals, businesses, and pharmacy and drug wholesaler owners and managers when a new or renewal license or registration application is submitted to the Board. Legislation authorizing the Board to request and obtain criminal history data was enacted in 2005. Iowa Code section 155A.40 June 2017 Terry Witkowski or Andrew Funk (515) 281-5944 657 IAC Various chapters Continue and complete 5-year review of all Board of Pharmacy rules Iowa Code subsection 17A.7(2) June 2017 Terry Witkowski (515)