247 Mass. Reg. 9.04

Current through Register 1523, June 7, 2024
Section 9.04 - Requirements for Dispensing and Refilling Prescriptions
(1) Whenever a prescription drug has been distributed solely under a generic name, the dispensing pharmacist shall record on the prescription the name of the manufacturer or, if the manufacturer's name is not available, the name of the distributor, packer, or repacker.
(2) The information on the label which the pharmacist, pharmacy intern, pharmacy technician or pharmacy technician trainee affixes to a prescription drug container shall be clearly printed or typed.
(3) Only a pharmacist, pharmacy intern, and certified pharmacy technician who has the approval of the pharmacist on duty may receive new prescriptions over the telephone from a prescriber or authorized agent.
(4) A pharmacist who refills a prescription for a controlled substance in Schedules in through VI shall record on the prescription:
(a) the date of dispensing;
(b) the amount of the drug dispensed; and
(c) his or her initials.
(5) A dispensing pharmacist who does not indicate the quantity of a drug dispensed on the back of a prescription which the pharmacist has refilled shall be deemed to have dispensed a refill for the full face amount of the prescription.
(6) Subject to the provisions of federal regulations at 21 CFR 1306, an automated data-processing system may be used as an alternative to the provisions of 247 CMR 9.04(4) and (5). This data-processing system may be used for the storage and retrieval of information pertaining to the refilling of prescriptions for controlled substances in Schedules III through VI.
(7) A pharmacist or anyone acting on behalf of a pharmacy or pharmacy department shall not collect prescriptions at industrial plants, places of business, or other sites where specific groups of people are regularly employed or affiliated, unless the prescriptions meet the following requirements:
(a) the prescriptions are for persons regularly employed at, or affiliated with, such plant, place of business or other such site;
(b) the prescriptions are collected in person by a pharmacist, pharmacy employee, or authorized agent of the pharmacy;
(c) the prescriptions are distributed in person to the patients or an authorized agent of the patient by a pharmacist, pharmacy employee, or authorized agent of the pharmacy; and
(d) the pharmacist shall be responsible for the conduct of any pharmacy employee or authorized agent acting on the pharmacist's behalf, and for verifying the authority of any person purporting to act on a patient's behalf; nothing in 247 CMR 9.04(7) shall be deemed to permit conduct of a prescription business in violation of any other regulation of the Board.
(8) A pharmacist may not fill or dispense any prescription for a hydrocodone-only extended release medication that is not in an abuse deterrent form unless:
(a) the medication is stored in a securely locked and substantially constructed cabinet at all times while on pharmacy premises;
(b) the medication is dispensed in a container with a child proof safety cap or within a locked box;
(c) the prescriber has supplied a new Letter of Medical Necessity for each prescription that includes the patient's diagnoses and treatment plan, verifies other pain management treatments are inadequate, and indicates a risk assessment was performed and the prescriber and patient entered into a Pain Management Treatment Agreement or indicates that the prescriber has determined that a Pain Management Treatment Agreement is not clinically indicated due to the severity of the patient's medical conditions, and the pharmacist keeps the Letter of Medical Necessity in a readily retrievable manner;
(d) each prescription is accompanied by a written warning approved by the Board regarding the specific dangers of hydrocodone-only extended release medication that is not in an abuse deterrent form;
(e) the pharmacist provides counseling that includes a review of the written warning supplied in accordance with 247 CMR 9.04(8)(d) and may include, but is not limited to:
1.the name and description of the medication;
2.the dosage form, dosage, route of administration and duration of drug therapy;
3.special instructions and precautions for preparation, administration and use by the patient;
4.common adverse or severe side effects or interactions and therapeutic contraindications;
5.techniques for self-monitoring drug therapy;
6.proper storage;
7.prescription refill information;
8.action to be taken in the event of a missed dose; and
9.signs and symptoms of an acute overdose.
(f) the pharmacist checks the patient's history on the online Prescription Monitoring Program.

247 CMR 9.04

Amended by Mass Register Issue 1265, eff. 7/18/2014.