Okla. Admin. Code § 535:15-3-9

Current through Vol. 42, No. 4, November 1, 2024

Section 535:15-3-9 - Non-resident pharmacies

(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.

Okla. Admin. Code § 535:15-3-9

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

Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015

Amended by Oklahoma Register, Volume 35, Issue 24, September 4, 2018, eff. 9/14/2018

Amended by Oklahoma Register, Volume 37, Issue 24, September 1, 2020, eff. 9/11/2020

Amended by Oklahoma Register, Volume 38, Issue 24, September 1, 2021, eff. 9/11/2021

Amended by Oklahoma Register, Volume 39, Issue 24, September 1, 2022, eff. 9/11/2022