21 N.C. Admin. Code 46.2502
Current through Register Vol. 39, No. 9, November 1, 2024
Section 46 .2502 - RESPONSIBILITIES OF PHARMACIST-MANAGER(a) The pharmacist-manager shall assure that prescription legend drugs and controlled substances are safe and secure within the pharmacy.(b) Except as expressly provided in Rule .1616 of this Chapter, the pharmacist-manager employed or otherwise engaged to supply pharmaceutical services may have a flexible schedule of attendance but shall be present for at least one-half the hours the pharmacy is open or 32 hours a week, whichever is less. A pharmacist employee not meeting this requirement may serve as temporary pharmacist-manager of the permit holder for a period not to exceed 90 days from the departure date of the previous pharmacist-manager, if the pharmacist employee is present at least 20 hours per week in the pharmacy. A pharmacy may not operate for a period of more than 30 days without a pharmacist employed or otherwise engaged as a permanent or temporary pharmacist-manager who has signed the permit for that pharmacy.(c) Whenever a change of ownership or change of pharmacist-manager occurs, the successor pharmacist-manager shall complete an inventory of all controlled substances in the pharmacy within 10 days. A written record of the inventory, signed and dated by the successor pharmacist-manager, shall be maintained in the pharmacy with other controlled substances records for a period of three years.(d) The pharmacist-manager shall develop and implement a system of inventory record-keeping and control that will enable that pharmacist-manager to detect any shortage or discrepancy in the inventories of controlled substances at that pharmacy at the earliest practicable time.(e) The pharmacist-manager shall maintain authority and control over all access to the pharmacy and shall be responsible for the security of the pharmacy. Except as provided in Rules .1413(c) and .1616(c)(1) and (2) of this Chapter, a pharmacist must be present at both the opening and closing of the pharmacy. If no pharmacist will be present in the pharmacy for a period of 90 minutes or more between the opening and closing of the pharmacy, the pharmacy shall be secured to prohibit unauthorized entry.(f) These duties shall be in addition to the duties of pharmacist-managers as set forth in the other rules in this Chapter.(g) A person shall not simultaneously serve as pharmacist-manager for more than one permit, unless: (1) any additional permits beyond that one permit is a limited service permit as provided in Rule .1616 of this Chapter;(2) the person is serving simultaneously as pharmacist-manager at two pharmacies holding full service permits, one of which is a newly permitted pharmacy that has not yet begun providing pharmacy services to patients. When the newly permitted pharmacy begins providing pharmacy services to patients or six months from the issuance of the new pharmacy permit, whichever occurs sooner, the person shall relinquish the former pharmacist-manager position and notify the Board of having done so.(h) When a pharmacy is to be closed permanently, the pharmacist-manager shall inform the Board and the United States Drug Enforcement Administration of the closing, arrange for the proper disposition of the pharmaceuticals, and return the pharmacy permit to the Board's offices within 10 days of the closing date. If possible, notice of the closing shall be given to the public by posted notice at the pharmacy at least 30 days prior to the closing date and 15 days after the closing date. Such notice shall notify the public that prescription files may be transferred to a pharmacy of the patient's or customer's choice during the 30-day period prior to the closing date. During the 30-day period prior to the closing date, the pharmacist-manager and the pharmacy's owner (if the owner is other than the pharmacist-manager), shall transfer prescription files to another pharmacy chosen by the patient or customer, upon request. Absent specific instructions from the patient or customer, the pharmacist-manager and the pharmacy's owner (if the owner is other than the pharmacist-manager), shall transfer prescription files to another pharmacy for maintenance of patient therapy and shall inform the public of such transfer by posted notice at the pharmacy for 15 days after the closing date, if possible. Controlled substance records shall be retained for the period of time required by law.(i) If possible, the pharmacist-manager shall ensure that notice of the temporary closing of any pharmacy for more than 14 consecutive days is given to the public by posted notice at the pharmacy at least 30 days prior to the closing date, and 15 days after the closing date. Such notice shall notify the public that prescription files may be transferred to a pharmacy of the patient's or customer's choice during the 30-day period prior to the closing date. During the 30-day period prior to the closing date, the pharmacist-manager and the pharmacy's owner (if the owner is other than the pharmacist-manager), shall transfer prescription files to another pharmacy chosen by the patient or customer, upon request.(j) The pharmacist-manager shall prepare a plan to safeguard prescription records and pharmaceuticals and minimize the interruption of pharmacy services in the event of a natural disaster such as hurricane or flood.(k) The pharmacist-manager shall separate from the dispensing stock all drug products more than six months out of date.(l) The pharmacist-manager shall report to the Board 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. This report shall be filed in writing on a form provided by the Board within 14 days of the owner representative or pharmacist-manager's becoming aware of the event. The pharmacist-manager shall retain all documents, labels, vials, supplies, substances, and internal investigative reports relating to the event. All such items shall be made available to the Board upon request.(m) The Board shall not disclose the identity of a pharmacist-manager who makes a report under Paragraph (l) of this Rule, except as required by law. No report made under Paragraph (l) of this Rule shall be released except as required by law.(n) In any Board proceeding, the Board shall consider compliance with Paragraph (l) of this Rule as a mitigating factor and noncompliance with Paragraph (l) of this Rule as an aggravating factor.21 N.C. Admin. Code 46 .2502
Authority G.S. 90-85.6; 90-85.21; 90-85.21A; 90-85.25; 90-85.26; 90-85.32;
Eff. May 1, 1989;
Amended Eff. April 1, 2006; February 1, 2005; August 1, 2002; December 1, 2001; April 1, 2001; April 1, 1999; July 1, 1996; March 1, 1992; October 1, 1990;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. October 3, 2017;
Amended Eff. November 1, 2021; March 1, 2019.Authority G.S. 90-85.6; 90-85.21; 90-85.25; 90-85.26; 90-85.32;
Eff. May 1, 1989;
Amended Eff. April 1, 2006; February 1, 2005; August 1, 2002; December 1, 2001; April 1, 2001; April 1, 1999; July 1, 1996; March 1, 1992; October 1, 1990.Amended by North Carolina Register Volume 33, Issue 19, April 1, 2019 effective 3/1/2019.Amended by North Carolina Register Volume 36, Issue 11, December 1, 2021 effective 11/1/2021.