Summary


The following rule amendments are made throughout Rule R156-17b: updating of references, renumbering of subsections, and minor grammatical and stylistic changes. Subsections R156-17b-102(16), (17), and (18) are added because the terms "DMP" (dispensing medical practitioner), "DMP designee", and "DMPIC" (dispensing medical practitioner-in-charge) are used throughout the rule, and definition of these terms is necessary for enforcement and education purposes. Subsection R156-17b-102(40) is added because the term "patient's agent" was used in S.B. 55, and definition of this term is necessary for enforcement purposes. Subsection R156-17b-102(57) updates the United States Pharmacopeia-National Formulary (USP-NF) to include Supplement 2, dated December 1, 2014. In Subsection R156-17b-105(1), an amendment is necessary due to S.B. 55. Subsections R156-17b-302(2), (7), and (8) amendments are necessary due to S.B. 55. An amendment to Subsection R156-17b-302(3) is necessary due to H.B. 114, which required licensure of Class C pharmacies located outside Utah. An amendment to Subsection R156-17b-302(5)(f) is necessary due to amendments to Section R156-17b-617c in this filing. Subsections R156-17b-303a(3) and (4) amendments are necessary due to S.B. 77. Other amendments to Subsection R156-17b-303a(4) remove the requirement that individuals apply for a pharmacy technician license within six months after completion of a pharmacy technician training program. This requirement is no longer necessary due to establishment of the pharmacy technician trainee license. Amendments to Subsection R156-17b-303a(6) remove the requirement that an applicant for the pharmacy technician license in Utah from another jurisdiction be licensed as a pharmacy technician in that jurisdiction. Removal of this requirement is necessary because some states do not license, register, or certify pharmacy technicians. An applicant from another jurisdiction continues to be required to: 1) engage in the practice of a pharmacy technician for a minimum of 1,000 hours in that jurisdiction; and 2) pass and maintain current PTCB (Pharmacy Technician Certification Board) and ExCPT (Exam for the Certification of Pharmacy Technicians) certification. Subsection R156-17b-303c(4) is removed because the Division is removing itself from the exam pre-approval process. Under the new process, the National Association of Boards of Pharmacy (NABP) determines who takes the North American Pharmacy Licensing Examination (NAPLEX) and the Multistate Jurisprudence Examination (MPJE). The new process will dramatically decrease the number of days that a pharmacist license application is pending with the Division. Section R156-17b-10 is no longer necessary due to S.B. 55. Subsection R156-17b-401(2) amendments are necessary due to S.B. 55 and S.B. 77. Section R156-17b-402 amendments are necessary due to S.B. 55 and S.B. 77. Subsection R156-17b-402(26) is removed due to S.B. 194, which passed during the 2013 General Session. S.B. 194 made it permissible for a pharmacy to sell prescription drugs to another pharmacy under certain conditions, and Subsection R156-17b-402(26) prohibits this practice; therefore, the existing language must be deleted. Section R156-17b-502 amendments are necessary due to S.B. 55 and S.B. 77. An amendment to Subsection R156-17b-502(2) clarifies that a pharmacy is required to comply with USP 795 and USP 797 only if these chapters are applicable to activities in the pharmacy. If a pharmacy is not engaged in compounding, it is not required to comply with USP 795 and USP 797. Subsection R156-17b502(24) is removed because some prescription container label standards established in USP-NF Chapter 17 are too subjective and difficult to enforce. Section R156-17b-601 amendments are necessary due to S.B. 77. Section R156-17b-603 amendments are necessary due to S.B. 77. Subsection R156-17b-603(3)(c) is removed because it is unnecessary and causes confusion. Sections R156-17b-604 and R156-17b-605 amendments are necessary due to S.B. 55. In Subsection R156-17b-606(1)(b), the number of years that a pharmacist must be licensed before qualifying as an approved preceptor is reduced from two to one. Section R156-17b-607 amendments are necessary due to S.B. 55 and S.B. 77. Section R156-17b-608 amendments are necessary due to S.B. 55. Sections R156-17b-609, R156-17b-610, R156-17b-612, and R156-17b-613 amendments are necessary due to S.B. 55 and S.B. 77. Subsection R156-17b-614a(1)(b) amendment requires that a pharmacy have a sink if a pharmacy transfers drugs from a manufacturer's or distributor's original container to another container. Pharmacies that only label containers are not required to have a sink that is separate from restroom facilities. Amendment to Subsections R156-17b-614a(1)(f) and (g) creates separate security system standards for pharmacies that dispense controlled substances. Amendment to Subsection R156-17b-614a(2) requires that a pharmacy keep a daily written or electronic log of the temperature of a refrigerator or freezer on days of operation. Each log entry must be retained for three years. Amendments to Subsection R156-17b-614a(3)(d) clarify that the master worksheet used for compounding may be stored electronically and that it must contain sample label information, not a sample label. Amendments to Subsection R156-17b-614a(5) remove the requirement that a pharmacy post the license of the facility and the license of each pharmacist, pharmacy intern, and pharmacy technician who is employed in the facility. This requirement is replaced with the requirement that a pharmacy maintain at the facility a current list of licensed employees involved in the practice of pharmacy. Amendments to Subsection R156-17b-614a(7) prohibit a pharmacy from dispensing a prescription drug or device to a patient unless a pharmacist or DMP is physically present and immediately available in the facility. Amendment to Subsection R156-17b-614a(9) decreases the period that a pharmacy must maintain a record of the initials or identification codes of each dispensing pharmacist or DMP. In the past, a pharmacy has been required to maintain this record permanently. The amendment decreases the period to five years. The amendment to Subsection R156-17b-614a(16) removes the requirement that a pharmacy's perimeter walls extend to the hard deck if the pharmacy stores drugs in a locked cabinet. Section R156-17b-614f is added for the purpose of establishing operating standards for a pharmacy that engages in central prescription processing or filling. Section R156-17b-615 amendments are necessary due to H.B. 114. Subsection R156-17b-615(6) is removed because it is not reasonable for all Class C pharmacies located outside Utah to undergo an inspection by the Division. Subsection R156-17b-615(20) is removed because H.B. 114 requires licensing of a pharmacy located outside Utah that engages in manufacturing, wholesaling, or distribution of prescription drugs in Utah. Subsection R156-17b-615(19) prohibits a Class C pharmacy from being located at the same address as a Class A, B, D, or E pharmacy. Additionally, Subsection R156-17b-619(19) establishes standards for Class C pharmacies located at the same address. Section R156-17b-617c amendments establish animal narcotic detection training facility as a classification of Class E pharmacy. Subsection R156-17b-617c(2) is removed because an employee working in these facilities is exempt under Section R156-37-305, and this is not the correct section to exempt these employees from a controlled substance license. Section R156-17b-618 amendments specify conditions under which an ownership change would require that a pharmacy submit a new license application. Section R156-17b-622 is added due to S.B. 55 for the purpose of establishing standards for a dispensing training program that DMP designees must complete in order to begin dispensing prescription drugs from a DMP clinic pharmacy. Section R156-17b-623 is moved from another section. Section R156-17b-624 is added due to S.B. 77.