105 CMR, § 721.020

Current through Register 1536, December 6, 2024

Section 721.020 - Prescription Formats

(A) Every Prescription generated in the Commonwealth of Massachusetts must be an Electronic Prescription issued in accordance with 105 CMR 721.000 and include an Electronic Signature unless it is a Prescription issued in accordance with an exception listed in 105 CMR 721.070.

(B) A Prescription must enable the practitioner to instruct the pharmacist to dispense a brand name Drug Product by indicating "no substitution", provided that:

(1) the indication of "no substitution" is not the default indication;

(2) the Prescription indicates that "Interchange is mandated unless the practitioner indicates 'no substitution' in accordance with the law"; and

(3) the indication of "no substitution" is a unique element in the Prescription and shall not be satisfied by use of any other element, including the signature.

(C) The name and address of the practitioner shall be clearly indicated on the Prescription. A hospital or clinic Prescription shall have the name and address of the hospital or clinic clearly indicated on the Prescription.

(D) The Prescription shall contain the following information:

(1) the registration number of the practitioner;

(2) date of issuance of the Prescription;

(3) name, dosage, and strength per dosage unit of the controlled substance prescribed, and the quantity of dosage units;

(4) name and address of the patient, except in a veterinary Prescription, a Prescription for naloxone or other opioid antagonist approved by the Department, or a Prescription issued pursuant to 105 CMR 721.070(A)(7) or 105 CMR 721.070(A)(12), in which case the name and address may be left blank; provided however, the person taking delivery of the Prescription for naloxone or other opioid antagonist as approved by the Department may, but is not required to, be used in place of the name of the patient;

(5) directions for use, including any cautionary statements required;

(6) a statement indicating the number of times to be refilled; and

(7) if the Prescription is for an opioid substance in schedule II, a notation that the patient may fill, upon request, the Prescription in an amount less than the recommended full quantity indicated.

(E) A Prescription issued by a certified nurse practitioner, psychiatric nurse mental health clinical specialist, or certified registered nurse anesthetist shall also contain the name of the supervising qualified healthcare professional unless the nurse issuing the Prescription is authorized for independent practice pursuant to 244 CMR: Board of Registration in Nursing.

(F) Written Prescriptions, where permitted by state and federal law, shall be issued in accordance with 105 CMR 721.000 on a form that contains the practitioner's signature, must comply with procedures set forth in 105 CMR 721.020(B) through 105 CMR 721.020 (F), and shall either be:

(1) transmitted via facsimile or similar technology; or

(2) written on a tamper-resistant form consistent with federal requirements for Medicaid.

(G) A Failover shall be considered an Oral Prescription, and shall not require a Written or Electronic follow-up Prescription, provided:

(1) the Prescription contains all information required by M.G.L. c. 94C, § 20(a) except for the practitioner's signature, and the Prescription is immediately entered into a compliant electronic pharmacy system or otherwise reduced to writing by the dispensing pharmacist;

(2) if the prescribing practitioner is not known to the dispensing pharmacist, the dispensing pharmacist makes a reasonable good faith effort to determine that the Failover was issued by a prescribing practitioner; and

(3) the Prescription is not for an Additional Drug, as defined by 105 CMR 700.001: Definitions.