02-392-4 Me. Code R. § 19-3

Current through 2024-51, December 18, 2024
Section 392-4-19-3 - Additional Requirements for Specific Forms of Prescription Drug Orders
1. Telephone Prescription Drug Orders

A pharmacist or pharmacy intern may accept an original or renewal prescription drug order telephoned to a pharmacy by a practitioner or authorized agent of the practitioner. A pharmacy technician may accept an original or renewal prescription drug order telephoned to a pharmacy by a practitioner or authorized agent of the practitioner to the extent authorized by the pharmacist on duty.

2. Facsimile Prescription Drug Orders
A. A pharmacist, pharmacy intern or pharmacy technician may accept a prescription drug order transmitted by facsimile machine or facsimile computer software directly to a pharmacy. Facsimile transmission of prescription drug orders for Schedule II controlled drugs is subject to the requirements of 21 CFR §1306.11(a), (e), (f) and (g).

[NOTE: Title 21 CFR §1306.11(a), (e), (f) and (g) require that the original manually-signed prescription for a Schedule II controlled drug must be presented to the pharmacist before the actual dispensing of the medication, except in the case of certain compounded substances, prescriptions written for a resident of a long term care facility, or prescriptions written for a patient enrolled in a hospice care program. For these prescriptions, the facsimile serves as the original written prescription.]

B. The prescription must contain the name of the practitioner and the authorized agent of the practitioner, if applicable, the date and time of the transmission, and the name of the pharmacy intended to receive the transmission.
C. If the person transmitting a prescription drug order by facsimile is the patient or authorized agent of the patient, the original prescription must be presented by the patient or authorized agent at the time the prescription is dispensed.
D. A pharmacy shall use a non-fading or bond paper to ensure the preservation of facsimile prescription drug orders for a period of 2 years.
3. Electronic Prescriptions for Noncontrolled Drugs
A. The prescription shall contain the electronic signature of the practitioner or the authorized agent of the practitioner, if applicable.
B. The prescription shall be electronically protected to prevent access, alteration or use by an unauthorized person.
C. A pharmacist, pharmacy intern or pharmacy technician who accepts a prescription sent by electronic mail, hypertext transport protocol or other internet protocol shall enter his or her initials into the dispensing record.
D. Only a pharmacist, pharmacy intern or pharmacy technician shall have access to a computer used to receive or retrieve prescription drug orders sent by electronic mail, hypertext transport protocol or other internet protocol.
E. A pharmacy shall implement reasonable data backup, protection and recovery protocols to retrieve electronically-stored prescription drug orders in the event of human error, power failure, computer malfunction, accident or catastrophe resulting in the loss, destruction or corruption of data. The measures implemented shall be sufficient to provide reasonable continuity of service to the public.
4. Electronic Prescriptions for Controlled Drugs
A. A pharmacist and pharmacy may process and fill an electronic prescription for a controlled drug only if:
(1) The prescription was issued (i.e., prepared, electronically signed and transmitted) by an authenticated practitioner in conformity with the federal rule provisions identified in paragraph B below; and
(2) The pharmacist and pharmacy complied in all respects with the federal rule provisions identified in paragraph B below that impose duties and responsibilities on pharmacists and pharmacies:
B. The following DEA rules apply to electronic prescriptions for controlled drugs processed and filled by pharmacists and pharmacies that are subject to the jurisdiction of the board and are incorporated into this chapter by reference:
(1)21 CFR Part 1311, "Requirements for Electronic Orders and Prescriptions" (April 1, 2012), and the following provisions of 21 CFR Parts 1300, 1304 and 1306 (April 1, 2012) to the extent such provisions apply to electronic prescriptions:
(2) Section 1300.03, "Definitions Relating to Electronic Orders for Controlled Substances and Electronic Prescriptions for Controlled Substances;"
(3) Section 1304.03, "Persons Required to Keep Records and File Reports," paragraphs (c) and (h);
(4) Section 1304.04, "Maintenance of Records and Inventories," paragraphs (b) and (h);
(5) Section 1304.06, "Records and Reports for Electronic Prescriptions;"
(6) Section 1306.05, "Manner of Issuance of Prescriptions," paragraph (e);
(7) Section 1306.08, "Electronic Prescriptions;"
(8) Section 1306.11, "Requirement of Prescription," paragraphs (a), (c), (d)(1) and (d)(4);
(9) Section 1306.13, "Partial Filling of Prescriptions, paragraph (a);
(10) Section 1306.15, "Provision of Prescription Information Between Retail Pharmacies and Central Fill Pharmacies for Prescriptions of Schedule II Controlled Substances," paragraph (a)(1);
(11) Section 1306.21, "Requirement of Prescription," paragraphs (a) and (c);
(12) Section 1306.22, "Refilling of Prescriptions," and
(13) Section 1306.25, "Transfer Between Pharmacies of Prescription Information for Schedules III, IV, and V Controlled Substances For Refill Purposes;"
C. Copies of the DEA rules identified in paragraph B above may be obtained as follows:
(1) Original publication in the Federal Register, 75 Fed.Reg. 16236-16319, March 31, 2010, as clarified in 76 Fed.Reg. 64813-64816, October 19, 2011, obtainable from the U.S. Government Printing Office, FDsys / Federal Digital System, at the following URL-

http://www.gpo.gov/fdsys/

(2) Codification in the Code of Federal Regulations, 21 CFR Parts 1300, 1304, 1306 and 1311 (revised as of April 1, 2012), obtainable from the U.S. Government Printing Office, FDsys / Federal Digital System, at the following URL-

http://www.gpo.gov/fdsys/

(3) Correction to inadvertent omission of § 1300.03 from the April 1, 2012 codification of 21 CFR Part 1300, published in the Federal Register, 77 Fed.Reg. 58767-56769, September 24, 2012, obtainable from the U.S. Government Printing Office, FDsys / Federal Digital System, at the following URL-

http://www.gpo.gov/fdsys/

02-392 C.M.R. ch. 4, § 19-3