2023 Laws of Puerto Rico › TITLE TWENTY-FOUR - Health and Sanitation (§§ 1 — 15010) › PART III - Food, Drugs, and Cosmetics (§§ 711 — 1031d) › Chapter 51 - Food, Drug and Cosmetic Act (§§ 711 — 732) › § 725 - Drug misbranding

A drug or device shall be deemed to be misbranded:
(a) If its labeling is false or misleading in any particular.
(b) If in package form and it does not bear a label setting forth:
(1) The name and place of business of the manufacturer, packer, or distributor, and
(2) an accurate statement of the quantity or the contents in terms of its weight, measure, or individual units of weight or measure contained in the complete package; Provided, That under clause (2) of this subsection reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
(c) If the words, statements, and diverse information required by this chapter do not prominently appear on the label or labeling and with such conspicuousness (as compared with other words, statements, designs or devices, in the labeling) and in such terms as to render them not likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(d) If it is for use by man and contains any quantity of the following narcotic or hypnotic substances: alpha eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, and sulphonmethane; or chemical derivatives of such substances, which the Secretary, after investigation, and by regulations has found to be and has designated as habit forming; unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement “Warning—May be habit forming”.
(e) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears:
(1) The common or usual name of the drug, if such there be, and
(2) in case it is fabricated from two (2) or more ingredients, the common or usual name of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances; Provided, That the Secretary shall, by regulation, establish exemptions to the extent that compliance with the requirements of clause (2) of this subsection is impracticable.
(f) Unless its labeling bears:
(1) Adequate directions for use.
(2) Adequate warnings against use in certain pathological conditions or for children where in these cases it may be dangerous to health, or against excessive dosage or unsafe methods or in regard to the duration of administration or application, in such manner and form, as might be necessary for the protection of the user; Provided, That where any requirements of clause (1) of this subsection, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement.
(g) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein; Provided, That the method of packing may be modified with the consent of the Secretary. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia with respect to the packaging and labeling thereof, unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the said Homeopathic Pharmacopoeia.
(h) If it is found by the Secretary to be a drug liable to deterioration, unless its label bears a statement of such precautions, and it is packaged in such form and manner as the Secretary shall by regulations require as indispensable for the protection of public health. No such regulation shall be established for any drug recognized in an official compendium until the Secretary shall have informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body shall have failed within a reasonable time to prescribe such requirements.
(i)
(1) If it is a drug and its container is so made, formed, or filled as to be misleading; or
(2) if it is an imitation of another drug, or
(3) if it is offered for sale under the name of another drug.
(j) If it is dangerous to health when administered in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.
(k) If it is a drug sold at retail for use by man, and contains any quantity of aminopyrine, barbituric acid, cinchopen, dinitrophenol, or sulfanilamide; unless it is sold on a written prescription signed by a member of the medical, dental or veterinary profession who is licensed by law to administer such drug, and its label bears the name and place of business of the seller, the serial number and date of such prescription, and the full name of such member of the medical, dental or veterinary profession.
(l) If it is a drug distributed at retail that may be habit forming or because of its dangerous potential effect or method for use, it is not safe to be used except under the supervision of a member of the medical, dental or veterinary profession, if it does not have the warning: “Federal Law Prohibits Dispensing Without Prescription” or its Spanish equivalent, save when sold according to subsection (m) of this section.
(m) A drug sold on a written prescription signed by a member of the medical, dental or veterinary profession (except drugs sold in the course of the conduct of a business of selling drugs pursuant to diagnosis by mail) shall be exempt from the requirements of this section if:
(1) Such member of the medical, dental or veterinary profession is licensed by law to administer such drug, and
(2) such drug bears a label containing the name and place of business of the seller, the serial number and date of such prescription, and the name of such member of the medical, dental or veterinary profession.
History —Apr. 26, 1940, No. 72, p. 492, § 15; May 30, 1976, No. 88, p. 265, § 1.