By Mr. Moore, a petition (accompanied by bill, Senate,
No. 1250) of Richard T. Moore for legislation relative to
drug sample. Public Health.
Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows:
SECTION 1. Chapter 112 of the General Laws as appearing in the 2002 Official Edition is hereby amended by inserting after section 12D, the following section:-
Section 12DD. As used in this section, the following words shall, unless the context clearly requires otherwise, have the following meanings:-
"Complimentary starter dose", a prescription packaged, dispensed and distributed in accordance with state and federal law that is provided to a dispensing prescriber free of charge by a manufacturer or distributor and dispensed free of charge by the dispensing prescriber to his or her patients.
"Department", the department of public health.
"Dispensing prescriber", any individual licensed to prescribe or dispense prescription drugs in this state.
(a) A dispensing prescriber who dispenses a complimentary starter dose drug to a patient shall give the patient at least all of the following information, either by dispensing the complimentary starter dose drug to the patient in a container that bears a label containing the information or by giving the patient a written document which may included, but is not limited to, a preprinted insert that comes with the complimentary starter dose drugs, that contains the following information:
1. the name and strength of the complimentary starter dose drug;
2. directions for the patient's use of the complimentary starter dose drug;
3. the expiration date of the complimentary starter dose drug or a statement as determined by the department.
(b) The information required under subsection (a) is in addition to, and does not supercede or modify, other state or federal law regulating the labeling of prescription drugs.
(c) A supervising physician may delegate in writing to a pharmacist practicing in a hospital pharmacy within a hospital licensed by the department, the receipt of complimentary starter dose drugs other than controlled substances as defined by Chapter 94C or federal law. When the delegated receipt of complimentary starter dose drugs occurs, both the pharmacist's name and the supervising physician's name shall be used, recorded, or otherwise indicated in connection with each receipt. A pharmacist described in this subsection may dispense a prescription for complimentary starter dose drugs written or transmitted by other means of communication by a prescriber.
(d) A person who distributes complimentary starter doses to prescribers shall maintain records that include at least all of the following information:
1. the name and address of the manufacturer distributing the complimentary starter doses;
2. the name and address of each prescriber to whom complimentary starter doses were distributed;
3. the type and amount of complimentary starter doses distributed to each prescriber.
(e) Upon request by the department, a person who distributes complimentary starter doses to prescribers shall provide the department access to the records required under section (d) and the department may periodically inspect locations from which complimentary starter dose drugs are dispensed.
(f) The department shall promulgate rules and regulations to enforce this act.