13.3 Nuclear Pharmacies, Class E Outlets & Dispensing Medical Practitioners

13.3 Nuclear Pharmacies, Class E Outlets & Dispensing Medical Practitioners

Blueprint item 4.7 covers the registration, licensure, and operating requirements of all practice settings. Utah's less common settings each have their own operating standards.

Nuclear pharmacies (R156-17b-614d)

• License class: a nuclear pharmacy preparing medications for a specific person is Class B if in Utah and Class D if outside Utah.
• Radioactive materials: it must hold, or have applied for, a Utah Radioactive Materials License, with enough space and equipment for its services.
• Staffing: a licensed Utah pharmacist must be immediately available on the premises whenever the facility is open. That pharmacist must also have the classroom and laboratory training and experience the Utah Radiation Control Rules require. Interns and technicians may work under the direct supervision of a qualified preceptor.
• Quality: it may dispense only radiopharmaceuticals that meet acceptable quality-assurance standards, and it must keep an appropriate library.
• Compounding: sterile preparations follow USP <797>, and Utah's compounding rule also requires USP <825> (radiopharmaceuticals) (R156-17b-614e).
• Exemption: a hospital nuclear medicine department, or the office of a physician, osteopathic physician, veterinarian, podiatric physician, or dentist, that holds a current Utah Radioactive Materials License does not need a Class B pharmacy license.

Class E pharmacies

Class E covers "all other pharmacies" and does not require a PIC (R156-17b-302(5)). Every Class E pharmacy must keep a written pharmacy care protocol naming its supervisor or director, its plan of care, the drugs it purchases, stores, uses, or accounts for, and any associated licensed health care providers, and it must comply with all applicable law (R156-17b-617a).

Dispensing medical practitioners (Part 8)

• Who: a physician, osteopathic physician, PA, APRN, or optometrist (acting within optometric scope) who is also licensed under Part 8 as a dispensing medical practitioner (DMP). Their existing license substitutes for pharmacist licensure requirements (§ 58-17b-803(1)–(2)).
• What they may dispense: cosmetic drugs and injectable weight-loss drugs they prescribed, following DOPL's approved list (for example, Latisse, hCG, hormonal contraception other than injectable or implantable methods, hydroquinone up to 4%, tretinoin up to 0.1%) (R156-17b-623); cancer drug treatment regimens under § 58-17b-805; and prepackaged drugs at an employer-sponsored clinic. DMPs may not dispense controlled substances except as § 58-17b-805 allows (§ 58-17b-102(56)(b)), and may not dispense gabapentin.
• Duties (§ 58-17b-803(4)): tell the patient that the drug may be obtained from an unaffiliated pharmacy, give directions and side effects, and explain how to contact the DMP. Report to the CSD like a pharmacist. A DMP may delegate dispensing to an employee acting under the direction of a DMP who is immediately available on site. DMP designees must complete a formal or on-the-job dispensing training program (R156-17b-622).
• DMP clinic pharmacy (§ 58-17b-804): a closed-door pharmacy in the DMP's place of practice. It needs no PIC if a DMP is designated as responsible and it follows DOPL rules. It renews on September 30 of odd-numbered years.

Exam strategy

For a specialty-setting question, answer three things:

1. Which license class applies? Nuclear pharmacies are Class B in Utah or Class D out of state. Labs, animal control, DME, research, medical gas, and 3PLs are Class E. A DMP clinic pharmacy is its own category.
2. Is a PIC required? Class E does not need one. A DMP clinic pharmacy may designate a responsible DMP instead.
3. Which record or security rule is unique? Animal control needs a perpetual inventory and one responsible party. DME records are kept five years. Medical gas cylinders are filled without adapters. 3PLs follow DSCSA and screen out product-tampering felons.