2023 Laws of Puerto Rico › TITLE TWENTY-FOUR - Health and Sanitation (§§ 1 — 15010) › PART V - Controlled Substances (§§ 2101 — 2608) › Chapter 111 - Controlled Substances Act of Puerto Rico (§§ 2101 — 2608) › Subchapter III - Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances (§§ 2301 — 2311) › § 2303 - Registration requirements

(a) Every person who wishes to obtain a registration under this chapter shall comply with the following requirements:
(1) File an application under oath before the Secretary of Health where he shall state that he meets the following requirements, to wit:
(A) That he has not been convicted of a felony or an offense implying moral turpitude.
(B) That he is over 18 years of age.
(C) That he has not been convicted of violating this chapter, or any local, federal or commonwealth law or foreign law relative to any substance defined in this chapter as a controlled substance and, if convicted, that five (5) years have elapsed since he served said sentence.
(D) That he is not addicted to narcotic drugs and to the best of his knowledge and understanding neither are his employees addicted to narcotic drugs.
(E) That the physical plant of the establishment described in the application has been provided with the necessary facilities to protect and safeguard the controlled substances the custody of which shall be entrusted to the applicant, in conformity with the rules and regulations promulgated to such effects by the Secretary of Health.
(F) That the applicant is duly authorized to operate in the establishment described in the application according to the laws in force.
(G) That the applicant of a registration to dispense drugs has been duly authorized to practice the profession in Puerto Rico.
(2) To accompany the application with a good conduct certificate issued by the Police of Puerto Rico.
(b) The Secretary of Health shall register the person who applies to manufacture controlled substances of those included in Schedule I or II of Subchapter II of this chapter when he determines that such person complies with the requirements stated in subsection (a) of this section and that the registration is consistent with the public interest. In determining the public interest, the following factors shall be taken into account:
(1) The possibility of maintaining an effective control against the diversion of particular controlled substances and any controlled substance in Schedule I or II compounded therefrom into other than legitimate medical, scientific, research, or industrial channels; by limiting the importation, and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequate conditions for legitimate medical, scientific, research and industrial purposes;
(2) the possibility of compliance with applicable federal and local law;
(3) the promotion of new techniques in the art of manufacturing these substances and the development of new substances;
(4) the criminal record of the applicant in accordance with local, commonwealth and federal laws relative to the manufacture, distribution and dispensing of such substances;
(5) the past experience of the applicant in the manufacture of controlled substances and the existence in the premises or establishment of the applicant of effective controls against diversion into other than legitimate channels, and
(6) such other factors as may be relevant to and consistent with the public health and safety.
(c) The Secretary of Health shall register an applicant to distribute controlled substances in Schedule I or II when he determines that such person complies with the requirements set forth in subsection (a) of this section and such registration is consistent with the public interest. In determining the public interest, the following factors shall be considered:
(1) The possibility of the maintenance of effective controls against diversion of determined controlled substances into other channels of distribution other than legitimate medical, scientific and industrial channels;
(2) the possibility of compliance with applicable federal and local law;
(3) prior conviction record of applicant in accordance with federal, state and local laws relating to the manufacture, distribution or dispensing of such substances;
(4) the past experience of the applicant in the distribution of controlled substances, and
(5) such other factors as may be relevant to and consistent with the public health and safety.
(d) The registration issued in accordance with subsections (b) and (c) of this section does not authorize the person registered to:
(1) Manufacture or distribute controlled substances included in Schedule I or II, other than those specified in the registration, or
(2) to manufacture any amount of said substances in excess of the quota which has been allocated by the Attorney General of the United States, under § 306 of the Federal Controlled Substances Act.
(e) The Secretary of Health shall register the person applying to manufacture controlled substances of those included in Schedule III, IV or V, when he determines that said person complies with the requirements set forth in subsection (a) of this section and such registration is consistent with the public interest. In determining the public interest, the following factors shall be considered:
(1) The possibility of maintenance of effective controls against diversion of a particular controlled substance and of any controlled substance in Schedule III, IV, or V compounded therefrom into other than legitimate medical, scientific or industrial channels;
(2) the possibility of compliance with applicable federal and local laws;
(3) promotion of technical advances in the art of manufacturing these substances and the development of new substances;
(4) prior conviction record of applicant under local, commonwealth and federal laws relating to the manufacture, distribution, or dispensing of such substances;
(5) past experience in the manufacture, distribution, and dispensing of controlled substances, and the existence in the premises or establishment of the applicant of effective controls against diversion into other than legitimate channels, and
(6) such other factors as may be relevant to and consistent with the public health and safety.
(f) The Secretary of Health shall register an applicant to distribute controlled substances in Schedules III, IV or V, when he determines that said person complies with the requirements included in subsection (a) of this section and that such registration is not inconsistent with the public interest. In determining the public interest, the following factors shall be considered:
(1) The possibility of maintaining effective controls against diversion of particular controlled substances into other than legitimate medical, scientific and industrial channels;
(2) the possibility of compliance with applicable local and federal law;
(3) the prior conviction record of applicant under local, commonwealth and federal laws relating to the manufacture, distribution or dispensing of such substances;
(4) the past experience of the applicant in the distribution of controlled substances, and
(5) such other factors as may be relevant to and consistent with the public health and safety.
(g) The Secretary of Health shall register the practitioner who requests to dispense controlled substances in Schedule II, III, IV or V, when he determines that said person complies with the requirements contained in subsection (a) of this section and that such registration is not inconsistent with the public interest. In determining the public interest, the following factors shall be considered:
(1) The possibility of maintaining effective controls against diversion of particular controlled substances into other than legitimate medical, scientific and industrial channels;
(2) the possibility of compliance with applicable local and federal law;
(3) prior conviction record of applicant under federal, state or local laws relating to the manufacture, distribution, or dispensing of such substances;
(4) past experience of the applicant in dispensing controlled substances, and
(5) such other factors as may be relevant to and consistent with the public health and safety.
(h) The Secretary of Health shall determine upon previous investigation the qualifications and the competence of each practitioner requesting registration to carry out research with controlled substances included in Schedule I, as well as the merits of each research protocol and the adequate procedures to be followed against the diversion of such controlled substances into other than the legitimate medical or scientific use.
The Secretary of Health may deny the registration for legitimate research purposes with substances of Schedule I to be performed by a practitioner deemed qualified only on a ground specified in § 2304 of this title, or on a ground of a prior practice of the applicant or that the procedures proposed make one believe that the applicant shall make abusive use of or shall unlawfully transfer them or shall not adequately protect the supply of these substances against the diversion into other than legitimate medical or scientific use.
(i) [Repealed. Act June 22, 1975, No. 52, § 2, p. 118, eff. 30 days after June 2, 1975.]
History —June 23, 1971, No. 4, p. 526, § 303; June 22, 1975, No. 52, p. 118, § 2, eff. 30 days after June 22, 1975.