Minn. R. agency 164, ch. 6800, OPERATION OF PHARMACIES, pt. 6800.3000

Current through Register Vol. 49, No. 17, October 21, 2024

Part 6800.3000 - PRESCRIPTIONS AND DISTRIBUTION OF DRUGS

Subpart 1.Acceptance of prescription drug orders and distribution of drugs.

A.Restrictions on pickup or delivery of prescription drug orders or filled prescriptions.No licensed pharmacist shall participate in any arrangement or agreement whereby prescription drug orders or filled prescriptions may be left at, picked up from, accepted by, or delivered to any place of business not licensed as a pharmacy. Provided, however, that nothing in this part prohibits a licensed pharmacist or a licensed pharmacy, by means of its employee or by use of a common carrier, from picking up prescription drug orders or delivering filled prescriptions at the office or home of the prescriber, at the residence of the patient, or at the hospital or long-term care facility in which a patient is confined. A pharmacy may deliver filled prescriptions at the place of employment of the patient or a designated caregiver of the patient only if the pharmacy:

(1) obtains and documents the authorization of the patient or patient's caregiver for delivery at the place of employment;

(2) ensures the filled prescription order is delivered directly to the patient or the patient's caregiver as authorized; and

(3) ensures the security of protected health information.

B. Direct prescription delivery.A pharmacy that employs the United States Postal Service or other common carrier to deliver a filled prescription directly to a patient must, based on the professional judgment of the pharmacist:

(1) use adequate storage or shipping containers and shipping processes to ensure drug stability and potency. The shipping processes must include the use of appropriate packaging material and devices, according to the recommendations of the manufacturer or the United States Pharmacopeia Chapter 1079, in order to ensure that the drug is kept at appropriate storage temperatures throughout the delivery process to maintain the integrity of the medication;

(2) use shipping containers that are sealed in a manner to detect evidence of opening or tampering;

(3) develop and implement policies and procedures to ensure accountability, safe delivery, and compliance with temperature requirements. The policies and procedures must address when drugs do not arrive at their destination in a timely manner or when there is evidence that the integrity of a drug has been compromised during shipment. In these instances, the pharmacy must make provisions for the replacement of the drugs; and

(4) provide for an electronic, telephonic, or written communication mechanism for a pharmacist, or a pharmacy intern working under the direct supervision of a pharmacist, to offer counseling to the patient. The patient must receive information indicating what the patient should do if the integrity of the packaging or medication has been compromised during shipment.

C.Adulteration.A drug is adulterated if it has been exposed to conditions of fire, water, or extreme temperature, which may have rendered it injurious to health.

Subp. 2.Fax machines.

Prescription drug orders may be transmitted to a pharmacy via the use of a fax machine only in accordance with this subpart and as permitted by law. For a pharmacy other than a hospital pharmacy that is transmitting solely within the institution, the procedures must provide for the identification of the person sending the prescription drug order. Unless the fax transmission is received on a machine generating a copy that is readily readable for at least five years, all fax transmissions of prescription drug orders shall be followed up within 72 hours with the original hard copy of the order or the pharmacist shall reduce the order received by fax to writing that is of permanent quality. Prescription drug orders for Schedule II-IV controlled substances received by fax shall be handled according to the rules of the federal Drug Enforcement Administration. Prescriptions faxed to the pharmacy by the patient are not to be filled or dispensed.

Subp. 3.Electronic prescriptions.

Any electronic prescription transmitted from the prescriber to the pharmacy must comply with Minnesota Statutes, section 62J.497, chapter 325L, and any applicable rules. Electronic prescriptions for controlled substance drugs must conform to the rules of the federal Drug Enforcement Administration. Except for prescription drug orders for drugs to be administered in an acute care hospital, an electronically transmitted prescription shall be transmitted only to the pharmacy of the patient's choice.

Subp. 4.Answering machines and electronic voice recording devices.

Only a practitioner or a practitioner's agent may transmit a prescription to a pharmacy's answering machine or electronic voice recording device. Prescriptions transmitted to a pharmacy's answering machine or an electronic voice recording device shall only be retrieved by a licensed pharmacist or registered pharmacist-intern working under the immediate and direct supervision of a pharmacist. A technician may not retrieve a prescription from these devices, except in the case where the practitioner or authorized agent of the practitioner is approving additional refills of a prescription previously dispensed from the pharmacy and no other changes are made to the prescription. Personnel used for clerical duties according to part 6800.3850, subpart 7, may not retrieve any prescription information from these devices. Prescriptions retrieved from these devices are considered verbal prescription drug orders that must be reduced to writing and are subject to the requirements of part 6800.3100, subpart 1.

Minn. R. agency 164, ch. 6800, OPERATION OF PHARMACIES, pt. 6800.3000

18 SR 1145; 31 SR 1673; 36 SR 237

Statutory Authority: MS s 151.06; 152.02