21 N.C. Admin. Code 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.
Notes
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.
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