2023 Laws of Puerto Rico › TITLE TWENTY-FOUR - Health and Sanitation (§§ 1 — 15010) › PART III - Food, Drugs, and Cosmetics (§§ 711 — 1031d) › Chapter 63 - Drugs Generally (§§ 911 — 950d) › § 931 - Barbiturates and other dangerous drugs—Definitions

The following words and phrases shall have the following meanings unless otherwise defined in the text of §§ 930—949 of this title:
(1) Antibiotics. — Includes the chemical compound or mixture of chemical compounds or derivatives thereof, salts and mixtures of said derivatives or salts, obtained from natural or synthetic sources and which are of bacteriostatic or bactericide medicinal use.
(2) Pharmacy aide. — Any person authorized by law to assist and aid a pharmacist in the dispensing of medicine under the direct supervision of the pharmacist.
(3) Barbituric or barbiturate. —
(a) Barbituric or barbiturate includes. —
(i) Any salt, derivative, mixture, or preparation of barbituric acid and any preparation which is totally or partly composed of said derivatives, provided same possess hypnotic or somniferous properties.
(ii) Any salt, derivative, mixture or preparation indicated for internal use and which, although not derived from said barbituric acid, possesses hypnotic or somniferous properties.
(b) Barbituric or barbiturate does not include. —
(i) Barbituric acid as such, nor derivatives thereof which do not possess hypnotic or somniferous properties.
(ii) Those pharmaceutical preparations which, in addition to the barbiturate in question, contain such amount of another drug or drugs as to make the action of said compound fundamentally free from its hypnotic or somniferous properties, provided such pharmaceutical preparation does not contain more than one-half (½) of the average dose of the barbiturate or drug in question specified in the official or nonofficial books where said barbiturates are included.
(4) Dentist. — The professional practitioner authorized by law to practice dental surgery in Puerto Rico.
(5) Drugstore. — A public establishment registered and licensed by law to preserve and sell at wholesale chemical products, pharmaceutical products, drugs, medicines, pharmaceutical or proprietary specialties, or poisons, and which may also deal at wholesale in other articles of lawful commerce customarily sold at wholesale to pharmacies in Puerto Rico.
(6) Manufacturer. — Any person who through the compounding, mixture, combination, culture, planting or other chemical or physical process, produces, prepares or repacks one (1) or more drugs and medicines; but the word does not include the pharmacist who compounds drugs and medicines for sale or dispending on medical prescription.
(7) Pharmacist. — Any person authorized by law to practice the pharmacy profession in Puerto Rico.
(8) Pharmacopoeia. — An official book prepared by the Revisal Committee thereof and published by the Board of Trustees by authority of the United States Pharmaceutical Convention and which contains a series of monographs on drugs, with their description, tests for their recognition and appraisal, and additional information for the purpose of establishing the quality and purity of said drugs.
(9) National Formulary. — An official book prepared by the National Formulary Committee under the supervision of the Council of said National Formulary and by authority of the American Pharmaceutical Association and published by said American Pharmaceutical Association and which contains a series of monographs on drugs, with their description, tests for their recognition and appraisal, and additional information, for the purpose of establishing the quality and purity of said drugs.
(10) Patent medicine or pharmaceutical specialty or pharmaceutical proprietary product. — All pharmaceutical products and all medicinal preparations manufactured, processed, prepared or compounded under a formula known by a natural or artificial person and which preparation has a defined commercial name and is presented in original containers.
(11) Physician. — The professional practitioner authorized by law to practice medicine in Puerto Rico.
(12) Medical or practitioner’s order or prescription. — A written order by a physician, dentist or veterinarian in order that certain medicines be prepared by a licensed pharmacist or a pharmacy aide in a pharmacy also duly registered.
(13) Internal use. — Includes oral administration or through parenteral injection.
(14) External use. — Every method of external administration of drugs, including inhalation, irrigations, gargles and ablutions.
(15) Veterinarian. — The professional practitioner authorized by law to practice veterinary medicine in Puerto Rico.
(16) Drug. —
(a) articles recognized as drugs in the Pharmacopoeia of the United States, in the Homeopathic Pharmacopoeia of the United States, in the National Formulary, or in any of the supplements of these official books at the time any investigation or transaction is carried out;
(b) articles intended to be used in the diagnosis, healing, soothing, treatment or prevention of diseases in the human being or in animals;
(c) articles (which are not foods) intended to affect the structure or any function of the human body or of animals, and
(d) articles intended to be used as components of any article specified in clauses (a), (b), or (c) of this subsection. It does not include devices or their components, parts or accessories.
(17) Dangerous drug. — Includes any of the following drugs or derivatives thereof or active principles, when such derivatives or active principles possess a similar therapeutical action:
(a) Amphetamine (benzedrine) or any other organic compound of a similar chemical formula possessing the characteristic pharmacological properties of this kind of drug, except for external use in combination with other ingredients which are inadequate for internal use.
(b) Natural or synthetic estrogens. — For internal or external use, when advertised, sold or recommended for the growth of women’s breasts.
(c) Ether. —
(i) Except for external use in combination with other ingredients inadequate for internal use.
(ii) Except for internal use in preparations according to the formulas contained in the official books.
(d) Sulfonamides for internal use.
(e) Thyroid or its active principle, thyroxin, and also any other preparation, compound or mixture thereof.
(f) Antimony and potassium tartar (tartar emetic) should the dose to be taken be more than one-half grain (½ gr.) in one (1) fluid ounce.
(g) Mercurial bichloride (corrosive sublimate) solid and in solution with more than one-fourth grain (¼ gr.) in one (1) fluid ounce.
(h) Carbolic acid (phenic acid) if of a concentration higher than five percent (5%), except those preparations, compounds or mixtures which contain derivatives of phenol, which are essentially used for disinfecting purposes.
(i) Ergot, its constituents or derivatives.
(j) Cotton-root bark.
(k) Pennyroyal oil.
(l) Savina oil.
(m) Tanacetin oil (tansy).
(n) Allyl-isopropyl acetyl-carbamide, known by the name of sedormid.
(o) Chloral hydrate.
(p) Diethylsulfondiethylmethane, known by the name of tetronal.
(q) Diethylsulfonmethylmethane, known by the name of trional.
(r) Dangerous drugs. — Shall include any preparation, compound or mixture which contains one or more barbiturates as defined in this section and whose sale is regulated in § 933 of this title.
(s) In addition to the provisions of the foregoing subsections, the term “dangerous drug” shall further include such drugs or preparations as the Secretary of Health, considering that their use without medical prescription may be noxious to health, may so declare through an order to the effect. No order of the Secretary of Health to include new drugs within the term “dangerous drugs”, as defined in §§ 930—949 of this title, shall take effect until after ten (10) days have elapsed since said order was published in a newspaper of general circulation in Puerto Rico. Any interested person shall have the right, within this period of time, to request a hearing on said order for the purposes of presenting his objection to and a petition for the revocation of the order. When any person has presented before the Secretary of Health a request for a hearing for the above purposes, the Secretary of Health shall hold such hearing as soon as possible.
History —July 13, 1960, No. 126, p. 350, § 2; June 14, 1966, No. 39, § 1.