P.R. Laws tit. 24, § 2305

2019-02-20 00:00:00+00
§ 2305. Labeling and packaging requirement

(a) It shall be unlawful to distribute a controlled substance in a commercial container unless said container bears a label as defined in § 201(k) of the Federal Food, Drug and Cosmetic Act containing an identifying symbol for such substance in accordance with the regulations of the Secretary of Health. A different symbol shall be required for each schedule of controlled substances.

(b) It shall be unlawful for the manufacturer of any controlled substance to distribute such substance unless the labeling of such substance contains, when and as required by this chapter, the identifying symbol required under subsection (a) of this section.

(c) The label of the container of a substance listed in Schedules II, III or IV must contain, when dispensed to or for a patient, a clear and concise warning that it is a crime to transfer said substance to another person.

The professional authorized to dispense any controlled substance listed in this chapter shall indicate [on] the label to be fixed on the container, among other information, the following:

(1) The name, telephone number and address of the professional establishment.

(2) The serial number corresponding to the prescription, as well as the date [on] which it was filled and its date of expiration.

(3) The name and surname of the patient.

(4) Instruction about the use for the patient, as recommended by the physician.

(5) The name of the professional who issued the prescription.

(6) The name of the medication, its strength and the lot number.

(d) The professional authorized to dispatch any of the controlled substances included in this chapter must orient and provide the patient with a printed summary to include warnings concerning the incorrect use and the side effects of the product [dispatched]. This measure shall apply to all medications, except for hospitals that provide medications to hospitalized patients.

(e) It shall be unlawful to distribute controlled substances in Schedule I or II, and narcotic drugs in Schedule III or IV, unless the bottle or other container, stopper, covering, or wrapper thereof is securely sealed as required by regulations of the Secretary of Health.

History —June 23, 1971, No. 4, p. 526, § 305; Aug. 15, 1999, No. 239, § 1.