Pharmacist-Manager Responsibilities

The North Carolina Pharmacy Practice Act and rules place responsibility and authority on the “pharmacist-manager” for the lawful, safe operation of pharmacy. The pharmacist-manager is “the person who accepts responsibility for the operation of the pharmacy in conformance with all statutes and regulations pertinent to the practice of pharmacy and distribution of drugs by signing the permit application, its renewal or addenda thereto.” 21 N.C.A.C. 46.1317(25)

The pharmacist-manager is the person to whom a pharmacy permit is issued. 21 N.C.A.C. 46.1601(e) If the pharmacy seeking a permit is located outside of North Carolina, the pharmacist-manager for the out-of-state permit issued by the Board must be the same person as the pharmacist-manager on the permit issued by the pharmacy’s home state. 21 NCAC 46.1607(c)(5) Before a permit is issued, the pharmacist-manager must complete an educational module on the North Carolina Pharmacy Practice Act and rules. That module is available in the on-line permit application section of the Board’s Licensure Gateway. 21 N.C.A.C. 46.1606

The pharmacist-manager also has the overall authority and responsibility to:

  • Ensure that, at all times, adequate personnel have been secured by the management of the store to properly render pharmaceutical service in a lawful and safe manner. 21 N.C.A.C. 46.1601(a)(1)

  • Ensure the safe, lawful and secure receipt of prescription orders and delivery of prescription drugs. 21 N.C.A.C. 46.1804(a)

  • Obtain and maintain equipment in the pharmacy adequate to meet the needs of the pharmacy’s patients. 21 N.C.A.C. 46.1601(a)(3)

  • Obtain and maintain a reference library as specified in 21 N.C.A.C. 46.1601(a)(4)

  • Conspicuously post the pharmacist’s manager license, the pharmacy permit, and every current renewal at the pharmacy, as well ensure that the licenses and current renewal of other pharmacists employed at the pharmacy are readily available for inspection by the Board. N.C.G.S. § 90-85.23

  • Ensure compliance with all requirements governing the use of automated medication systems. 21 N.C.A.C. 46.3402

  • Preserve pharmacy records and maintain them for at least three years. N.C.G.S. § 90-85.26

  • Provide records requested by the Board within 48 hours of a request. 21 N.C.A.C. 46.2508

The pharmacist-manager has authority over and responsibility for pharmacy personnel and staffing. Some emphasis points:

  • The pharmacist-manager is responsible for hiring pharmacy technicians and for ensuring their proper registration with the Board. N.C.G.S. § 90-85.15A

  • As noted above, ensure that, at all times, adequate personnel have been secured by the management of the store to properly render pharmaceutical service in a lawful manner. 21 N.C.A.C. 46.1601(a)(1)

  • Notify the Board of any change in pharmacy personnel within 30 days of the change. N.C.G.S. § 90-85.21(a)

  • If the pharmacy provides compounding services, be knowledgeable in the specialized functions of preparing, labeling, and dispensing compounded drug preparations or designate (and be responsible for) another pharmacist who is. 21 NCAC 46.2801(g)

  • If the pharmacy operates as a remote medication order entry pharmacy, ensure that pharmacy personnel are trained and able to perform at the same level of competence, attention, and proficiency as if the personnel were in the dispensing pharmacy. 21 N.C.A.C. 46.1816(d)(3)(D)

A pharmacist-manager’s general day-to-day responsibilities are set forth in 21 N.C.A.C. 46.2502. Some emphasis points:

  • May only serve as pharmacist-manager for one pharmacy. 21 N.C.A.C. 46.2502(g). Exception: May serve as a pharmacist-manager for multiple “limited service” pharmacy permits or as pharmacist-manager for two full pharmacy permits if one of the two is newly permitted and has not begun providing patient services.

  • Controls all access to the pharmacy. 21 N.C.A.C. 46.2502(e).

  • Must be present for half of the hours the pharmacy is open or 32 hours per week, whichever is less. 21 N.C.A.C. 46.2502(b). In-person supervision requirements for the pharmacist-manager of a limited service permit are detailed at 21 NCAC 46.1616 (see also Guidance to Rules Governing Limited Service Permits)

  • May serve as a “temporary” pharmacist manager for 90 days. A temporary pharmacist-manager need only be in the pharmacy 20 hours per week. 21 N.C.A.C. 46.2502(b).

  • When there is a change in the pharmacy owner or the pharmacist-manager, the successor pharmacist-manager must inventory all controlled substances within 10 days and maintain a copy of that inventory for three years. 21 N.C.A.C. 46.2502(c). This is, of course, in addition to the biennial controlled substances inventory required under federal law.

  • The pharmacist-manager must prepare a “plan to safeguard prescription records and pharmaceuticals in the event of a natural disaster such as a hurricane or flood.” 21 N.C.A.C. 46.2502(j).

  • North Carolina requires that the pharmacist-manager “report to the Board of Pharmacy information that reasonably suggests that there is a probability that a prescription drug or device dispensed from a location holding a permit has caused or contributed to the death of a patient or customer.” 21 N.C.A.C. 46.2502(l).

Health care facility pharmacy-specific responsibilities (which are in addition to, not in lieu of, the general pharmacist-manager responsibilities) are found throughout Section .1400 of the Board’s rules. Some points of emphasis:

  • The pharmacist-manager shall be assisted by a sufficient number of pharmacists and personnel to operate the pharmacy competently and safely. 21 N.C.A.C. 46.1410

  • Determine whether the facility will deploy Validating Technicians and, if so, develop policies and procedures governing their exercise of authority under 21 N.C.A.C. 46.1418

  • Develop and implement procedure assuring safe and effective use of automated dispensing devices in the facility. 21 N.C.A.C. 46.1419

  • Develop policies and procedures for compounding parenteral medications. 21 N.C.A.C. 46.1411(b)(1)

  • Participate in any effort to create a drug formulary at the facility. 21 N.C.A.C. 46.1411(b)(3)

  • Develop policies and procedures requiring appropriate inspections of patient care units or other areas where medications are dispensed, administered, or stored. 21 N.C.A.C. 46.1411(b)(10)

  • Make arrangements for the provision of drugs and pharmaceutical care when the pharmacy is not open 24/7. 21 N.C.A.C. 46.1413(a).

  • Develop, with medical staff, policies and procedures governing the contents of, storage of, and access to auxiliary medication inventories. 21 N.C.A.C. 46.1414(d).

  • Develop a system of control and accountability of all drugs administered in or dispensed from the emergency department. 21 N.C.A.C. 46.1415(b).

  • When the pharmacist-manager has “information that suggests that there is a probability that a prescription drug or device dispensed from a location holding a permit has caused or contributed to the death of a patient,” she must document the incident and preserve “all documents, labels, vial, supplies, substances and internal investigative reports relating to the event” and make them available to the Board. 21 N.C.A.C. 46.1414(j)(3).