Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C
Section 700.010 - Dispensing and Labeling of Sample Medications by Practitioners
Universal Citation: 105 MA Code of Regs 105.700
Current through Register 1537, December 20, 2024
(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.
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