Current through Vol. 42, No. 1, September 16, 2024
(a)
Definitions. "Non-resident pharmacy" means a pharmacy, not located
in Oklahoma, which transacts or does business in Oklahoma by soliciting,
receiving, dispensing, and/or delivering prescription medications and devices
to Oklahoma residents.
(b)
Licensing requirements. A non-resident pharmacy shall:
(1) make application and receive an annual
non-resident pharmacy license at a fee set by the Board;
(2) maintain in good standing a pharmacy
license in its resident state;
(3)
comply with the Oklahoma Secretary of State requirements for conducting
business in this state.
(4) submit
on initial licensure and on renewals a written report of an inspection
conducted within the previous twenty-four (24) months by the non-resident's
state or by any organization approved by the Board;
(5) be in a commercial location and not a
personal dwelling or residence;
(6)
submit on initial licensure the name and license number of an Oklahoma licensed
pharmacist in charge (PIC) who is responsible for the non-resident's pharmacy
compliance with Oklahoma laws. The name of the Oklahoma licensed PIC shall be
reported to the Board, in writing, with each renewal and/or within 10 days of
any change of such PIC.
(7) the
pharmacy registrant may request, in writing, that the Board allow additional
time for a new pharmacist-in-charge to get Oklahoma licensed in emergency or
urgent situations. If the Board determines circumstances warrant they may grant
up to a 90 day extension.
(c)
Laws and regulations.
Oklahoma pharmacy laws and regulations shall apply to the practice of pharmacy
for the Oklahoma portion of the nonresident pharmacy's practice or operation.
(1) The pharmacist manager (also called
pharmacist-in-charge (PIC)) and all other pharmacists performing
pharmacist-only functions in Oklahoma licensed non-resident pharmacies must be
currently licensed in the state in which the non-resident pharmacy is located.
The PIC must also be licensed by the Oklahoma Board.
(2) The pharmacist manager (PIC) and/or
pharmacy owner(s), or partners, or corporate officer(s) shall be responsible
for compliance with Oklahoma laws and regulations pertaining to the provisions
of receiving, dispensing, and/or delivering of prescriptions or prescription
medications and devices to Oklahoma residents.
(3) No pharmacist may serve as a PIC in more
than one pharmacy at a time.
(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.
(d)
Inspections. Non-resident pharmacies are subject to inspection and
investigation. The Board may conduct on-site periodic routine inspections and
investigations during reasonable business hours.
(e)
Records. Prescription
records documenting prescriptions delivered and distributed to Oklahoma
residents shall be identifiable, readily retrievable, and available for Board
review.
(1) Records must be maintained for
not less than five years.
(2)
Patient records shall comply with
535:15-3-14.
(3) Schedule II, III, IV, and V prescription
records. These records shall be sent to the Oklahoma Prescription Drug
Monitoring program as set out in Title 63 of the Oklahoma Statutes.
(f)
Counseling
services. Non-resident pharmacies shall provide accessible toll-free
telephone counseling by a licensed pharmacist for patient drug inquiries during
regular working hours. The counseling provided shall comply with the
pharmaceutical care requirements listed in OAC 535:10-9.
(g)
Prescription integrity. A
pharmacy or registrant shall not increase the quantity of a prescription
without the authorization of the prescriber. Unless specified otherwise by the
prescriber, a pharmacist may exercise his professional judgement to dispense up
to a ninety (90) day supply for maintenance non-controlled dangerous drugs, if
sufficient quantity has been authorized by the prescriber on the original
prescription, including any refills. Increasing controlled dangerous drugs or
any medications that require reporting to the controlled substance database are
prohibited. (See 59 O.S.353.20.2)
(h)
Written drug diversion detection
and prevention. The pharmacy and the pharmacy manager shall implement
and follow a written drug diversion detection and prevention policy and
procedure. This policy and procedure shall be available for Board
review.
(i)
Pharmacy
refrigerator and freezer temperature logs.
(1) All refrigerators and freezers used to
store medications shall have a sensor or thermometer capable of reading
internal temperatures.
(2) The
internal temperatures maintained in the refrigerators and freezers shall be
appropriate for the products stored.
(3) Temperatures in refrigerators and
freezers shall be logged twice daily (AM and PM) on days the pharmacy is open
for business or shall have continuous temperature monitoring.
(A) Pharmacy name, date, time, temperature,
and staff person taking reading shall be logged at a minimum for paper
logs.
(B) Temperature logs shall be
maintained on paper or electronically for two years and be available for
inspection.
(4) If there
is a temperature reading that falls outside of appropriate ranges, a notation
must be made on the temperature log detailing the corrective measures which
were taken.
(5) It is the PIC's
responsibility to review the temperature readings to ensure compliance with
appropriate storage temperatures.
(j)
Prescription shipping. The
pharmacy shall maintain and use adequate storage or shipment containers and use
shipping processes to ensure drug stability and potency. Such shipping
processes shall include the use of appropriate packaging material and/or
devices to ensure that the drug is maintained at an appropriate temperature
range to maintain the integrity of the medication throughout the delivery
process.
(1) No prescription shipped to a
citizen of Oklahoma should have a temperature excursion that exceeds the
temperature storage conditions outlined in the package insert or by the
manufacturer of the drug product.
(2) A pharmacy or pharmacist shall refuse to
deliver by mail or common carrier a prescription drug which, in the
professional opinion of the pharmacy or pharmacist, may be therapeutically
compromised by delivery by mail or common carrier.
(3) A mail order or non-resident pharmacy
shall make available to the patient or patient's caregiver the contact
information for the Oklahoma State Board of Pharmacy.
Added at 11 Ok Reg 3431,
eff 6-27-94; Amended at 13 Ok Reg 2807, eff 6-27-96; Amended at 17 Ok Reg 2626,
eff 7-1-00; Amended at 26 Ok Reg 2274, eff 7-1-09; Amended at 27 Ok Reg 2249,
eff 7-11-10
