Current through Vol. 42, No. 1, September 16, 2024
(a)
Pharmacy staffing responsibility. Each pharmacy shall employ an
adequate number of pharmacists to perform the practice of pharmacy as defined
by the Oklahoma Pharmacy Act with reasonable safety.
(b)
PIC. Each pharmacy, in order
to obtain and maintain a pharmacy license, must have a licensed pharmacist as
the PIC.
(1) A PIC is designated by his
signature on the original pharmacy application or by the appropriate
notification to the Board as required in
535:15-3-10 (a),
and is responsible for all aspects of the operation related to the practice of
pharmacy. These responsibilities include, but are not limited to the:
(A) Supervision of all employees as they
relate to the practice of pharmacy;
(B) Establishment of policies and procedures
for safekeeping of pharmaceuticals that satisfy Board requirements, including
security provisions when the pharmacy is closed;
(C) Proper record keeping system for the
purchase, sale, delivery, possession, storage, and safekeeping of
drugs;
(D) Proper display of all
licenses;
(E) Annual controlled
drug inventory; and,
(F)
Maintenance of prescription files;
(2) Failure of the pharmacy to have a PIC who
fulfills these responsibilities is a violation of this code by both the
pharmacy and PIC.
(3) No pharmacist
may serve as a PIC in more than one pharmacy at a time. This requirement shall
not apply to charitable pharmacies or hospital drug rooms.
(4) The PIC shall be present and practicing
at the pharmacy for which he holds the PIC position no less than 20 hours per
week during the pharmacy's ordinary course of business. In the event the
pharmacy's normal hours of business are less than 40 hours per week the PIC
shall be present and practicing at least 50 percent of the normal business
hours.
(5) A PIC shall work
sufficient hours in the pharmacy to exercise control and meet the
responsibilities of the PIC.
(c)
PIC's and pharmacy's
responsibilities. The following describe responsibilities of the
pharmacy and PIC.
(1) Where the actual
identity of the filler of a prescription is not determinable, the PIC and the
pharmacy where the prescription was filled will be the subject of any charges
filed by the Board.
(2) The
pharmacy and the PIC are responsible to establish and maintain effective
controls against prescription errors.
(3) The pharmacy and/or PIC shall notify the
Board immediately by certified mail of the separation of employment of any
pharmacist, pharmacy intern, or pharmacy technician for any suspected or
confirmed drug or pharmacy related violation. If the PIC is terminated for such
reason, the owner or other person in charge of the pharmacy shall notify the
Board by certified mail.
(4) The
pharmacy, pharmacist, and/or PIC shall establish and maintain effective
controls against the diversion of prescription drugs into other than legitimate
medical, scientific, or industrial channels as provided by federal, state or
local laws or rules.
(5) The
pharmacy, pharmacist and PIC are responsible for supervision of all employees
as they relate to the practice of pharmacy.
(d)
Responsibility for automated
pharmacy systems. This subsection describes the responsibilities of the
pharmacy and the PIC for automated pharmacy systems.
(1) Prior written notice must be provided to
the Board of the installation or removal of automated pharmacy systems. Such
notice must include, but is not limited to the:
(A) Name and address of the
pharmacy,
(B) Name of
PIC,
(C) Name of the manufacturer
& model of system.
(2) The system being implemented should
conform to Board automated pharmacy system guidelines.
(3) The pharmacy shall monitor the automated
pharmacy system with a quality assurance program.
(4) The pharmacy, pharmacist, and/or PIC
shall establish and maintain effective controls against the diversion of
prescription drugs into other than legitimate medical, scientific, or
industrial channels as provided by federal, state or local laws or
rules.
(5) The pharmacy, pharmacist
and PIC are responsible for supervision of all employees as they relate to the
practice of pharmacy regarding automation.
(e)
Responsibilities for personnel
identification. The PIC and the pharmacy are responsible to assure that
the public is able to distinguish pharmacy technicians, auxiliary support
personnel, and/or interns from any pharmacist in the pharmacy.
(1) All pharmacy technicians, auxiliary
support personnel, and/or interns must wear a designation tag and be distinctly
identifiable from a practicing pharmacist.
(2) Designation tags must be clear, readable
and lettered with "Rx Tech", "Tech", "Clerk", or "Intern".
(3) All pharmacy interns, technicians or
clerks must identify themselves as such on any phone calls initiated or
received while performing pharmacy functions.
(f)
Written drug diversion detection
and prevention. The pharmacy, pharmacist, and/or PIC shall implement and
follow a written drug diversion detection policy. The policy shall be available
for Board review.
(g)
Inspections. Pharmacies are subject to inspection. The Board
and/or its authorized representatives may conduct on-site periodic routine
inspections and investigations during reasonable business hours.
(h)
Remodel. The pharmacy and
the PIC are responsible to notify the Board in writing in advance of any
remodel in the pharmacy that would result in a change in square footage or
additional storage areas. Such pharmacy shall be subject to inspection by the
Board and shall be required to pay and inspection fee.
(i)
Closing of a Pharmacy. The
pharmacy and the PIC are responsible to notify the Board in writing within ten
(10) days of closing a pharmacy. The notification shall include, but not be
limited to:
(1) Date of closing
(2) Copy of final CDS inventory,
(3) Disposition of pharmacy
records,
(4) Disposition of
prescription drugs, and
(5) Return
of pharmacy license.
(j)
Reporting.
(1) The pharmacy and
the PIC shall report any theft or significant loss of any drugs to the Board
within one day of discovery. The pharmacy and the PIC must complete and submit
a DEA 106 form for any theft or significant loss of controlled substances to
DEA within the required time. A copy shall be sent to the Board within fourteen
(14) days of the filing of the DEA Form 106.
(2) A change in PIC must be reported to the
Board in writing within ten (10) days,
(3) A pharmacy that is closing due to lack of
staffing or for some other reason and will not be open during normal business
hours when patients would expect the pharmacy to be open must email the
following information to the Board within twenty-four (24) hours.
(A) License number of the pharmacy.
(B) Name of the pharmacy.
(C) Address of the pharmacy.
(D) Name of the pharmacist in charge
(PIC).
(E) Date(s) that the
pharmacy will be closed.
(F) Hours
the pharmacy will be closed.
(G)
Detailed explanation for closing.
Amended at 12 Ok Reg
2593, eff 6-26-95; Amended at 14 Ok Reg 3024, eff 7-1-97; Amended at 15 Ok Reg
3272, eff 7-13-98; Amended at 17 Ok Reg 2626, eff 7-1-00; Amended at 18 Ok Reg
2736, eff 7-1-01; Amended at 20 Ok Reg 2476, eff 7-11-03; Amended at 21 Ok Reg
2452, eff 7-1-04; Amended at 24 Ok Reg 2257, eff 7-1-07; Amended at 27 Ok Reg
2249, eff 7-11-10
