P.R. Laws tit. 24, § 726
(a) No person shall sell, deliver, offer for sale, hold for sale or give away any new drug unless:
(1) The application with respect thereto has become effective under § 505 of the Federal Act, or
(B) a full list of the articles used as components;
(C) a full statement of its composition;
(D) a full description of the methods used in, and the facilities and controls used for, its manufacture, processing, and packing;
(E) such samples of such drug and of the articles used as components thereof as the Secretary may require, and
(F) specimens of the labeling proposed to be used for its sale.
(2) when it is not subject to the Federal Act, such drug has been tested and it has been found not to be unsafe for use under the conditions prescribed, recommended or suggested in the labeling thereof, and prior to selling or offering for sale such drug, there has been filed with the Secretary an application setting forth:
(A) A full report of the investigations which have been made to show that it can or cannot be used with safety;
(b) The application provided for in subsection (a)(2) of this section shall become effective sixty (60) days after the filing thereof, except that, after due notice to the applicant and reserving for him an opportunity for a hearing, if the Secretary finds that the drug is not safe for use under the conditions prescribed, recommended or suggested in the proposed labeling thereof, he shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective.
(c) This section shall not apply:
(1) To a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety of drugs, provided the same is plainly labeled “For investigational use only”; or
(2) to a drug sold in this Commonwealth at any time prior to the enactment of this act or introduced into interstate commerce at any time prior to the enactment of the Federal Act, or
(3) to any drug which is licensed under the Virus, Serum, and Toxin Act of July 1, 1902 (U.S.C. 1934 ed. title 42, Chap. 4).
(d) An order refusing to permit an application under this section to become effective may be revoked by the Secretary.
History —Apr. 26, 1940, No. 72, p. 492, § 16, eff. 90 days after Apr. 26, 1940.