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) › § 712 - Definitions

For the purpose of this chapter:
(a) Secretary. — Shall mean the Secretary of Health; and
Inspector. — shall mean Health Inspector.
(b) Person. — Shall include individual, partnership, corporation, and association.
(c) Food. — Shall mean (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such articles.
(d) Drug. — Shall mean (1) articles recognized in the United States Pharmacopoeia, in the Homeopathic Pharmacopoeia of the United States, or in the National Formulary, official on the date any investigation is made, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (4) articles intended for use as a component of any article specified in clause (1), (2), or (3); but shall not include devices or their components, parts, or accessories.
(e) Device. — Except when used in subsection (k) of this section and in §§ 713(j), 721(f), 725(c) and 728(c) of this title shall mean instruments, apparatus and contrivances, including their components, parts and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (2) to affect the structure or any function of the body of man or other animals.
(f) Cosmetic. — Shall mean (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles, except that such term shall not include soap when used for cleansing purposes only.
(g) Official compendium. — Shall mean the United States Pharmacopoeia, the Homeopathic Pharmacopoeia of the United States, and the National Formulary, which are official on the date an investigation is made, or any supplement to any of them.
(h) Label. — Shall mean a display of written, printed or graphic matter upon the immediate container or the original container of the manufacturer, and every requirement made under authority of this chapter that any word, statement, declaration or other information appearing on the label shall not be considered to be complied with unless such word, declaration, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
(i) Immediate container. — Shall not include package liners.
(j) Printed matter of the original container of the manufacturer (labeling). — Shall include all labels, tags, and all written, printed or graphic matter (1) affixed to the outside of an article or to any of its containers or wrappers, or (2) accompanying or included in the container of said article; Provided, That the phrase “printed matter” in the absence of additional explanation, shall always mean “printed matter on the original container of the manufacturer”.
(k) If an article is alleged to be misbranded because the printed matter or labeling is misleading, or if an advertisement is alleged to be false because it is misleading, then in determining whether such printed matter or labeling or advertisement is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, declaration, word, design, sign, device, sound, or in any combination thereof, but also the extent to which the printed matter or labeling, or advertisement fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the printed or labeling, or advertisement thereof or under such conditions of use as are customary or usual.
(l) Advertisement. — Shall mean all representations disseminated in any manner or by any means, other than by labeling, or printed matter on the original container of the manufacturer for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of food, drugs, devices or cosmetics.
(m) The representation of a drug, in its printed matter or labeling, or advertisement, as an antiseptic shall mean to be a representation that it is a germicide, except when the printed matter or labeling or advertisement explains that it is intended for inhibitory use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body.
(n) New drug. — Shall mean (1) any medicinal drug the composition of which is not generally recognized by experts whose scientific training and experience qualify them to evaluate the safety of said drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof; or (2) any drug the composition of which is such that such drug, as a result of investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
(o) Contaminated with filth. — Shall be applied to any food, drug, device or cosmetic not adequately protected from dust, dirt, and as far as may be necessary by all reasonable means, from all foreign or injurious contaminations.
(p) The provisions of this chapter regarding the selling of food, drugs, devices, or cosmetics, shall be considered to include also the manufacture, production, processing, packing, exposure, offer, possession, and holding of any such article for sale; and likewise the sale, dispensing, and giving of any such article and the supplying or applying of any such articles in the conduct of any food, drug or cosmetic establishment.
(q) Federal Act. — Shall mean the Federal Food, Drug and Cosmetic Act (Title 21 U.S.C. 301 et seq.; 52 Stat. 1040 et seq.).
History —Apr. 26, 1940, No. 72, p. 492, § 2, eff. 90 days after Apr. 26, 1940.