105 CMR, § 700.010

Current through Register 1533, October 25, 2024

Section 700.010 - Dispensing and Labeling of Sample Medications by Practitioners

(A) Other than for immediate administration, a practitioner shall not dispense controlled substances to an ultimate user in the course of professional practice, except as follows:

(1) A Schedule VI sample medication in a single dose or in such quantity as is in the opinion of the practitioner appropriate for the treatment of the patient but not exceeding a 30-day supply per dispensing; provided, however, that this quantity may be increased to a 90-day supply if dispensed as part of an indigent patient drug program and deemed appropriate in the professional judgment of the practitioner;

(2) A Schedule II through V sample medication in a single dose or in such quantity as in the opinion of the practitioner is essential for the immediate treatment of the patient.

(B) All sample medications dispensed by a practitioner shall be properly labeled.

(1) Whenever a sample medication is dispensed by a practitioner, a label shall be affixed to the outside of the package, and shall include the following information:

(a) a practitioner's name and address;

(b) date of dispensing; and

(c) name of the patient, unless a veterinary product.

(2) In addition, the following information must be included on the label unless already provided for on the manufacturer's packaging of the sample medication:

(a) name, dosage form and strength of the sample medication;

(b) clear, simple and brief directions for use and any necessary cautionary statements; and

(c) date on which the medication will expire.

(3) Information provided to the patient under 105 CMR 700.010(B)(2) shall be, in the professional judgement of the practitioner, presented in a manner which can be easily understood by the patient. A combination of written information, labeling and counseling may be used to meet this requirement, based upon the individual needs of each patient.

(4) If multiple packages of the same sample medication are dispensed at the same time to the same patient, the samples may be placed in a larger container to which the label containing applicable information required by 105 CMR 700.010 has been affixed.