reglab/statecodes huggingface dataset:
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter II - The Profession (§§ 407a — 407e) › § 407d - Functions of the pharmacy technician

The pharmacy technician may perform, under direct supervision of the pharmacist, technical or administrative functions delegated to him/her by the pharmacist regarding the dispensing of prescription drugs and devices delegated by the pharmacists, which do not require the professional judgment of the pharmacist for their performance. The pharmacy technician may not verify prescriptions or advise the patient on the prescribed drugs. He/she shall neither perform any of the other functions of the pharmacist included in subsections (b), (c), (d), (e), (f), (g), (h), (i) or (j) of § 407b of this title.
History —Sept. 3, 2004, No. 247, § 2.04; Jan. 8, 2010, No. 7, § 3.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter II - The Profession (§§ 407a — 407e) › § 407e - Norms or standards of the practice of pharmacy

The Board, in collaboration with pharmaceutical professional organizations and educational institutions, shall adopt by regulations, the pharmacy practice guidelines, which shall include the norms or standards to provide pharmaceutical services of quality, based on the responsibilities and functions of the profession of pharmacy that are in harmony with the provisions of this chapter.
History —Sept. 3, 2004, No. 247, § 2.05.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter III - Pharmacy Board (§§ 408 — 408c) › § 408b - Witness summoning and taking of oaths

The Board may summon witnesses and compel their appearance before the Board as a whole or before any of its members to which the investigation of an issue or the examination of a document has been entrusted, to testify or to present any book, file, register, record or document of any kind related to a matter within the jurisdiction of the Board. All summons issued by the Board bear its official seal and be signed by the Chairperson thereof.
The Board shall have the power to resort to the Court of First Instance to in aid of its jurisdiction to compel appearance. The court, upon proof of just cause, may issue an order for the person to appear before the Board, to testify and present the required documents on said issue. Failure to follow such order shall constitute contempt of court and may be punished as such.
The members of the Board are hereby empowered to take oaths on statements or testimonies related to the issues under the jurisdiction of the Board, thus keeping a separate register for each member of the Board of the statements taken, indicating the date of the sworn statement, complete name and personal circumstances of the person testifying or taking oath and a brief account of the contents of the sworn statement.
History —Sept. 3, 2004, No. 247, § 3.03.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter III - Pharmacy Board (§§ 408 — 408c) › § 408c - Delegation of functions

The Board may delegate on one or more Examining Officials any of its investigative and adjudicative powers and functions, including the power to take oaths, summon witnesses and require the furnishing of documentary evidence and of other kind.
History —Sept. 3, 2004, No. 247, § 3.04.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter IV - Regulations of the Pharmacist and the Phamacy Technician (§§ 409 — 409n) › § 409 - Requirements to practice the profession of pharmacy

Only those persons who meet the following requirements shall practice the profession of pharmacy in Puerto Rico:
(a) Hold a pharmacist license obtained pursuant to the provisions of this chapter or a pharmacist license in effect obtained pursuant to the provisions of the Act herein repealed.
(b) Have his/her license and recertification registered in the Register of Pharmacists of the Health Professionals Regulations and Certifications Office, as provided by this chapter.
(c) Be an active member of the College of Pharmacists of Puerto Rico, pursuant to the provisions of §§ 431—441 of this title.
History —Sept. 3, 2004, No. 247, § 4.01.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter IV - Regulations of the Pharmacist and the Phamacy Technician (§§ 409 — 409n) › § 409a - Licence—Requirements

Any person who wishes to obtain a license to practice the profession of pharmacy in Puerto Rico shall meet the following requirements:
(a) Be of legal age and submit a negative criminal history certificate.
(b) Hold a diploma evidencing that he/she has obtained a degree in said profession from a higher education institution or school of pharmacy in Puerto Rico or abroad, the study program of which is accredited or acknowledged by the Council on Higher Education of Puerto Rico or its successor. Such accreditation or acknowledgment shall be based on the criteria established by said agency in consultation with the Board of Pharmacy and in harmony with the standards of accreditation of the American Council of Pharmaceutical Education. Those persons graduated from schools of pharmacy of foreign countries shall submit a certificate of educational equivalency granted by the National Association of Boards of Pharmacy.
(c) Having satisfactorily completed an internship period of a minimum of one thousand five hundred (1,500) hours under the supervision of a preceptor pharmacist. The Board may increase, by regulations, the number of hours required after having notified the schools of pharmacy of Puerto Rico within at least one (1) year before. The internship may be carried out entirely in one pharmacy or as provided by the Board by regulations, one part in a community or institutional pharmacy, and another part in the pharmaceutical industry or in another area in which the profession is practiced. In the case the pharmacy intern is a student enrolled in supervised practice courses in an accredited school of pharmacy, the criteria and standards established by the Board through regulations for these cases shall apply.
(d) Having approved the licensure examination required by this chapter.
(e) Having paid the license fees established by this chapter.
History —Sept. 3, 2004, No. 247, § 4.02.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter IV - Regulations of the Pharmacist and the Phamacy Technician (§§ 409 — 409n) › § 409b - License—Application

Any person who wishes to take the licensure examination required by this chapter to obtain the pharmacist license, shall submit to the Board the following documents:
(a) An application for the licensure examination on the form provided by the Board to these effects and in the manner and within the term prescribed by regulation.
(b) Evidence accrediting that the applicant meets the requirements established by subsections (a), (b), and (c) of § 409a of this title.
(c) An official document with photo and signature accrediting the identity of the applicant.
(d) The payment of pharmacist licensure examination fees established by § 409n of this title.
The applicants who fail the examination and want to repeat the same must submit a new application.
History —Sept. 3, 2004, No. 247, § 4.03.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter IV - Regulations of the Pharmacist and the Phamacy Technician (§§ 409 — 409n) › § 409d - License—Reciprocity

(a) The Board may issue a pharmacist license to any person who holds a valid license issued by the Board of Pharmacy or by other competent entity from any jurisdiction with which the Board has a reciprocity agreement in effect, provided said person meets the following requirements:
(1) Be of legal age and present a negative criminal history certificate.
(2) Be a graduate from a pharmacy college or school which is recognized or accredited by the highest pertinent accrediting authority in Puerto Rico based on criteria established by said agency in consultation with the Board of Pharmacy.
(3) Have not less than one (1) year experience in the practice of the pharmacy profession in the jurisdiction where he/she has obtained his/her pharmacist license.
(4) Pass the examination on legal aspects of the practice of pharmacy as stated in subsections (b) or (c) of § 409c of this title.
(5) Have not incurred any of the causes established in this chapter for denying of a pharmacist license in the jurisdiction where he/she has obtained his/her license or in another in which he/she has practiced the pharmacy profession.
(6) Meet all other applicable requirements established in this chapter to practice the pharmacy profession in Puerto Rico as provided by the Board by regulations.
(b) Any pharmacist who wishes to obtain a license pursuant to the provisions of this section shall file with the Board the following documents:
(1) An official document with photo and signature which attests to his/her identity.
(2) An application for the examination on legal aspects and a reciprocity license application, in the forms provided by the Board to that effect.
(3) Evidence attesting that he/she meets the requirements established in clauses (1), (2), (3), and (5) of subsection (a) of this section.
(4) The original of his/her pharmacist license, together with a certification issued by the competent authority attesting that said license has not been revoked, temporarily suspended, or otherwise restricted.
(5) The payment of the fees for the pharmacist licensure examination application, as established in § 409n of this title.
(c) In the event the applicant does not pass the examination on legal aspects as required, he/she may take it again by submitting a new examination application together with the corresponding fees.
(d) The limitations and restrictions established in § 409c of this title on the number of chances to take licensure examinations shall apply to any examination application submitted pursuant to this section.
History —Sept. 3, 2004, No. 247, § 4.05.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter IV - Regulations of the Pharmacist and the Phamacy Technician (§§ 409 — 409n) › § 409e - License—Granting and recertification

(a) Granting the license. — The Board shall grant a pharmacist license to any person who meets the requirements established in §§ 409a—409d of this title, as the case may be, after having paid the license fees fixed in subsection (a) of § 409n of this title.
The pharmacist license shall have the form, registration, characteristics, information, numbering, series or identification as established by regulations. The Board shall register said license in the Register of Pharmacists of the Health Professionals Regulations and Certifications Office.
The pharmacist license, once it has been issued and registered pursuant to the provisions of this chapter, except if suspended, cancelled, or revoked, authorizes the person to whom it is issued to exercise the functions and prerogatives of the pharmacy profession, as established in this chapter.
(b) Recertification. — Any pharmacist who wishes to continue practicing the pharmacy profession in Puerto Rico shall apply to the Board for his/her recertification every three (3) years, as required by §§ 3001 et seq. of Title 24, and by the regulations adopted thereunder. The recertification application shall be made using the form provided by the Board to that effect and be submitted together with the following documents:
(1) Evidence attesting that the applicant has met the continuing education requirement, as required under the aforecited §§ 3001 et seq. of Title 24 and its regulations.
(2) A certification from the College of Pharmacists of Puerto Rico, attesting that the applicant is an active member of said entity.
(3) The payment of pharmacist recertification fees as provided in § 409n of this title.
The Board shall issue the recertification not later than thirty (30) days after the date of having submitted the application, and shall order the corresponding registration into the Register of Pharmacists of the Health Professionals Regulations and Certifications Office.
History —Sept. 3, 2004, No. 247, § 4.06.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter IV - Regulations of the Pharmacist and the Phamacy Technician (§§ 409 — 409n) › § 409f - Certification for specialties under the pharmacy profession

(1) The Board may certify as a specialist in an area of the pharmacy profession any authorized pharmacist who holds a specialty certificate granted by a recognized professional institution or agency. This shall also apply to other professional credentials, such as the immunization administration certificate.
(2) The Board shall establish through regulations the criteria and procedures for granting a specialty certificate. No pharmacist may advertise or purport to be a specialist in an area of the pharmacy profession in Puerto Rico if he/she does not hold a specialty certificate issued by the Board.
(3) Any pharmacist who wishes to administer vaccines in Puerto Rico shall apply before the Board of Pharmacy for the immunization administration certificate. The application shall include:
(a) Name and surnames, pharmacist license number, and health professional registration number in effect, and a certification that he/she is a member in good standing of the College of Pharmacists of Puerto Rico.
(b) Proof that he/she has completed at least twenty (20) credit hours in an institution recognized by the Center for Disease Control and Prevention (CDC) and the Accreditation Council for Pharmacy Education (ACPE).
(c) Proof that he/she holds a Basic Cardiopulmonary Resuscitation (CPR) Certificate in effect, issued by the American Heart Association or the American Red Cross.
(d) Payment of the corresponding fees for the immunization administration certificate application, as provided in § 409n of this title.
(4) The immunization administration certificate issued by the Board of Pharmacy shall be valid for three (3) years as of its date of [issuance]. It may be renewed by the Board upon the filing by the pharmacist of a written application therefor, at least sixty (60) days before its expiration date, including the following:
(a) Name and surnames, pharmacist license number, health professional registration number, and a certification that he/she is a member in good standing of the College of Pharmacists of Puerto Rico.
(b) Proof of having completed at least 1 contact hour (0.1 CEU) of continuing education related to immunizations during each one of the preceding three (3) years.
(c) Proof that he/she holds a Basic Cardiopulmonary Resuscitation (CPR) Certificate in effect, issued by the American Heart Association or the American Red Cross.
(d) Payment of the corresponding fees for the immunization administration certificate renewal, as provided in § 409n of this title.
History —Sept. 3, 2004, No. 247, § 4.07; Jan. 8, 2010, No. 7, § 5.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter IV - Regulations of the Pharmacist and the Phamacy Technician (§§ 409 — 409n) › § 409g - Technician—Requirements

Only the persons who meet the following requirements shall be able to practice the pharmacy technician occupation in Puerto Rico:
(a) Hold a certificate obtained pursuant to the provisions of this chapter or a certificate in effect obtained pursuant to the provisions of the law which is hereby repealed.
(b) Have his/her certificate and recertification registered into the Register of Pharmacy Technicians of the Health Professionals Regulations and Certifications Office.
History —Sept. 3, 2004, No. 247, § 4.08.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter IV - Regulations of the Pharmacist and the Phamacy Technician (§§ 409 — 409n) › § 409h - Technician—Certificate

Any person who wishes to obtain a pharmacy technician certificate shall meet the following requirements:
(a) Be eighteen (18) years old or older, and submit a negative criminal history certificate.
(b) Have [passed] the high school general course in a school in Puerto Rico which is recognized by the Department of Education or in a school accredited by the corresponding authority of the place where the same is located.
(c) Have a diploma, a certificate or any other official document attesting that he/she has satisfactorily [passed] a pharmacy technician course in an educational institution in Puerto Rico which is accredited by the highest corresponding accrediting authority, as the case may be, or in an institution of the United States or the United States Armed Forces which is recognized or accredited by the corresponding Authority in Puerto Rico and that, to the satisfaction of the Board, meets the minimum requirements of the pharmacy technician course.
(d) Have satisfactorily completed an internship period for a minimum term of one thousand (1,000) hours under the direct supervision of a preceptor pharmacist in a pharmacy. The Board may, by regulation, increase the minimum number of internship hours required after having notified the institutions with academic programs for pharmacy technicians in Puerto Rico, not less than one (1) year in advance of the date on which the change was approved.
(e) Have passed the pharmacy technician certification examination, as required under this chapter.
(f) Have paid the fees for the pharmacy technician certification established under this chapter.
History —Sept. 3, 2004, No. 247, § 4.09.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter IV - Regulations of the Pharmacist and the Phamacy Technician (§§ 409 — 409n) › § 409i - Technician—Application for examination

Any person who wishes to take the certification examination application required under this chapter to obtain a pharmacy technician certificate, shall submit the following documents to the Board:
(a) A certification examination application, on the form provided by the Board and within the term it establishes by regulations.
(b) Evidence attesting that the applicant meets the requirements established in subsections (a), (b), (c), and (d) of § 409h of this title.
(c) An official document with a photograph and signature attesting to the identity of the applicant.
(d) The payment of the fees for the application to take the pharmacy technician certification examination, as established under § 409n of this title.
Candidates who do not pass the certification examination and wish to take the examination again, shall submit a new application.
History —Sept. 3, 2004, No. 247, § 4.10.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter IV - Regulations of the Pharmacist and the Phamacy Technician (§§ 409 — 409n) › § 409j - Technician—Examination

(a) Purpose. — The purpose of the certification is to assess the competencies of the candidate to begin practicing the pharmacy technician occupation.
(b) Examination. — The certification examination shall consist of a written exam on the application of the concepts of the following subjects: pharmacy math; pharmacotherapy; and technical, administrative, and legal aspects of the practice of pharmacy.
The Board may offer the candidate the option of taking the examination prepared by the National Pharmacy Technician Certifying Board, in which case, the candidate shall also take the examination on the legal aspects of the pharmacy profession offered by the Board.
The Board, when necessary to assess the competency of such candidates, may substitute or include other subjects in the examination. This change shall take effect two (2) years after the date of its approval and shall be published in a newspaper of general circulation in Puerto Rico and notified to the educational institutions of Puerto Rico with pharmacy technician programs or courses, within sixty (60) days from the date of its approval.
(c) Certification examination passing score. — The Board shall prepare and offer the examination to candidates for certification as pharmacy technicians, following the criteria, norms and procedures established by regulations. The Board may use consultants or agencies engaged in preparing and evaluating certification examinations. The minimum score or grade to be obtained in order to pass the examination shall be fixed by regulation. Candidates shall be guaranteed their right to review their answers in the examination within ninety (90) days from the date of receipt of the examination results.
[If] the candidate fails to obtain the minimum score, he/she may take the examination again up to a maximum of five (5) times. For the purpose of issuing the certificate, the examination shall expire after six (6) years of its approval.
(d) Examination orientation. — The Board shall prepare and publish a handbook with information to acquaint candidates with the norms and procedures of the licensure, the administration of the examination, the type of examination, the evaluation method and the minimum score required to pass. The handbook shall be given to all candidates applying for the certification examination after they have provided a check or money order payable to the order of the Secretary of the Treasury or a credit or debit card, following the norms established by the Secretary of the Treasury concerning this means of payment, for the amount to be determined by the Board, taking as a base the expenses incurred for its preparation and publication. The amount to be charged may not exceed the actual cost represented by said expenses. These funds shall be covered into the special account provided for in § 409n of this title.
History —Sept. 3, 2004, No. 247, § 4.11.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter IV - Regulations of the Pharmacist and the Phamacy Technician (§§ 409 — 409n) › § 409k - Technician—Certificate; reciprocity

The Board shall establish by regulation the norms and procedures for reciprocity concerning pharmacy technician certificates.
History —Sept. 3, 2004, No. 247, § 4.12.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter IV - Regulations of the Pharmacist and the Phamacy Technician (§§ 409 — 409n) › § 409l - Technician—Certificate; granting and recertification

(a) Granting. — The Board shall grant a pharmacy technician certificate to any person who meets the requirements established in this chapter, after he/she has paid the certificate fees fixed therein.
The certificate shall be have the form, registration, characteristics, information, number, serial number or identification established by regulation. The Board shall register said certificate in the Register of Pharmacy Technicians of the Health Professionals Regulation and Certification Office.
The pharmacy technician certificate issued and registered pursuant to the provisions of this chapter, except if suspended, cancelled, or revoked, authorizes the person to whom it is issued to discharge the functions set forth in this chapter under the direct or immediate supervision of a pharmacist.
(b) Recertification. — Any pharmacy technician who wishes to continue practicing as such in Puerto Rico shall apply to the Board his/her recertification every three (3) years, as required by §§ 3001 et seq. of Title 24, and by the regulations adopted thereunder.
The recertification application shall be made on the form provided by the Board to that effect and be submitted together with the following documents:
(1) Evidence attesting that the applicant has met the continuing education requirement imposed under the §§ 3001 et seq. of Title 24 and its regulations.
(2) The payment of fees for pharmacy technician recertification, as established in § 409n of this title.
The Board shall issue the recertification not later than thirty (30) days from the date the application has been submitted and shall order its corresponding registration into the Register of Pharmacy Technicians of the Health Professionals Regulation and Certification Office.
History —Sept. 3, 2004, No. 247, § 4.13.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter IV - Regulations of the Pharmacist and the Phamacy Technician (§§ 409 — 409n) › § 409n - Fees

(a) The following fees are hereby established for the items indicated below; Provided, That the same shall be in effect from the date of approval of this act until the Board establishes other fees by regulation:
(1) Application for pharmacist license examination $ 75.00
(2) examination 50.00 Application for pharmacist technician certificate
(3) Internship authorization 10.00
(4) Pharmacist license 100.00
(5) Pharmacist license by reciprocity 150.00
(6) Pharmacy technician certificate 50.00
(7) Pharmacist recertification and registration 30.00
(8) Pharmacy technician recertification and registration 25.00
(9) License or certificate copy 15.00
(10) another jurisdiction 25.00 License certification to apply for reciprocity in
(11) (application/renewal) 25.00 Immunization Administration Certificate
(12) certificates 25.00 Other certifications related to licenses and
(b) The fees established herein shall be paid by check or money order payable to the order of the Secretary of the Treasury or by credit or debit card, following the norms and procedures provided by the Secretary of the Treasury concerning said means of payment.
(c) The amount of the fees for examination applications shall not be refunded to the applicant when he/she fails to show up to the examination or if he/she fails the same.
(d) All funds collected by the Board on account of the fees established in this subchapter shall be covered into the Health Fund created under the provisions of Act No. 26 of November 13, 1975, as amended, to be used by the Board of Pharmacy pursuant to regulations approved to that effect.
(e) The Board shall keep in a separate account the funds received by virtue of the provisions of subsection (s) of § 408a of this title.
History —Sept. 3, 2004, No. 247, § 4.15; Jan. 8, 2010, No. 7, § 6.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter V - Manufacture, Distribution and Dispensation of Medications (§§ 410 — 410o) › § 410 - Medication Register

No person in Puerto Rico may display, offer for sale, distribute, sell, deliver, store, give away or donate, or make any advertisement whatsoever for medications, with or without prescription, natural products, homeopathic products, or devices to be used by human beings or other animals unless said medications, natural products, homeopathic products, or devices have been registered in the Department for the marketing, distribution, dispensation and sale thereof in Puerto Rico.
The Secretary shall prescribe by regulations the procedures for the registration of medications electronically, be they prescription or no prescription medications. Any medications approved by the Food and Drug Administration (FDA) shall be registered using a compact disc (CD), in digital format or in the electronic format prescribed by the Department for such purposes, together with the payment of the corresponding fees as provided by regulations. Provided, That in order to streamline the electronic register only the following shall be required:
(a) The name and address of the entity that prepares, manufactures or repackages the medication.
(b) The name and address of the distributor in Puerto Rico.
(c) The shape, size, and concentration of the issued medication (specifying whether it is a solid or a liquid).
(d) A copy of the valid manufacturer’s license issued by the country of origin of the manufacturer of the medication to be registered, and/or the Federal Food and Drug Administration (FDA) approval.
(e) The National Drug Code (NDC).
(f) The exact text of all the warnings, labels, and printed materials that are adhered to or accompany the original container.
(g) A copy of the valid license, issued in accordance with the provisions of this chapter.
Provided, further, That the Secretary may create, through regulations, registers for natural products, homeopathic products, and devices in the digital or electronic format provided by the Department for such purposes.
If there is any change in the information submitted in the original application for any of the abovementioned registers, the person shall update the new information in the electronic register within a term not to exceed five (5) calendar days, along with the payment of the corresponding fees.
History —Sept. 3, 2004, No. 247, § 5.01; Nov. 15, 2013, No. 133, § 1.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter V - Manufacture, Distribution and Dispensation of Medications (§§ 410 — 410o) › § 410c - Medications with special dispensation or management requirements

(a) Controlled substances.— Pharmacists shall dispense controlled substances defined in §§ 2101 et seq. of Title 24, known as the “Puerto Rico Controlled Substances Act” and the “Federal Controlled Substances Act”, following the criteria and procedures established in said acts and their regulations.
(b) Radioactive medications.— For the dispensation of radioactive medications or radiopharmaceuticals, pharmacists must comply with all Commonwealth and federal requirements concerning the management of radioactive substances. All radiopharmacies shall obtain from the Secretary a special authorization to dispense said medications and meet the criteria and requirements to be established by regulation.
(c) Parenteral medications.— For the composition and dispensation of sterile parenteral medications or any other medications requiring special aseptic techniques, pharmacies shall request and obtain from the Secretary a special authorization for dispensing such medications and meet the requirements to be established by regulation.
(d) Biological products.— For the dispensation or dispatching of biological products, a license shall be requested and obtained from the Secretary as provided by the Regulations of the Department of Health for the Conservation and Registration of Biological Products. Biological products shall be kept refrigerated at a temperature not higher than 12.5 degrees centigrade or 55 degrees Fahrenheit, or according to manufacturer’s specifications.
(e) Vaccines.— The pharmacist certified to administer immunization may only administer vaccines to people aged eighteen (18) and over.
History —Sept. 3, 2004, No. 247, § 5.04; Jan. 8, 2010, No. 7, § 7.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter V - Manufacture, Distribution and Dispensation of Medications (§§ 410 — 410o) › § 410d - Nonprescription medications

(a) Nonprescription medications, with the exception of those indicated further, may be acquired in pharmacies and other establishments duly authorized by and registered at the Department.
(b) The following nonprescription medications may only be acquired at pharmacies:
(1) Nonprescription medications containing controlled substances as defined in §§ 2101 et seq. of Title 24, known as the “Puerto Rico Controlled Substances Act”.
(2) Injectable medications.
(3) Medications requiring refrigeration for their storage and conservation.
(4) Other medications as determined by the Department by regulation.
(c) The Department may exercise the rulemaking authority conferred thereto under the preceding subsection (b)(5) [sic] of this section only when it determines, based on studies conducted pursuant to generally accepted scientific criteria, that there is a substantial risk of serious adverse effects on health which are directly attributable to the consumption, abuse or inadequate administration of the medication.
(d) Nonprescription medications shall be kept in their original package with the manufacturer’s labeling and kept in an appropriate environment and at an appropriate temperature so that their quality, purity and potency do not deteriorate or are not diminished in any way.
History —Sept. 3, 2004, No. 247, § 5.05.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter V - Manufacture, Distribution and Dispensation of Medications (§§ 410 — 410o) › § 410e - Pharmaceutical industry

(a) Any industry engaged in the manufacture of medications shall hold a license from the Secretary which authorizes it to manufacture, market and distribute the same in Puerto Rico. It shall also meet the following requirements:
(1) It shall have one (1) or more pharmacists who shall participate in the multidisciplinary team which ensures compliance with the provisions of laws and regulations of the Department of Health and other government agencies concerning the manufacture, packaging and distribution of medications in Puerto Rico, except for enterprises that are engaged in the manufacturing, packaging and distribution of oxygen and any other medical gas, in which case, as a staffing requirement, these may select either an authorized pharmacist or a chemist. The industry shall give the Department of the Health notice of the identification of the head pharmacist regardless of the number of pharmacists working on its multidisciplinary team.
(2) It shall pay the fees established by this chapter for the operation of a pharmaceutical industry.
History —Sept. 3, 2004, No. 247, § 5.06; Dec. 14, 2007, No. 208, § 1.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter V - Manufacture, Distribution and Dispensation of Medications (§§ 410 — 410o) › § 410f - Wholesale distribution

(a) All wholesaler drugstores, wholesale prescription medication distributors, wholesale nonprescription medication distributors, and wholesale veterinary medication distributors shall apply to and obtain from the Secretary a license authorizing them to conduct their corresponding activity in Puerto Rico.
(b) Wholesale prescription medication distributors and wholesaler drugstores shall have the professional services of at least one (1) pharmacist to oversee controls in the distribution of medications. Oversight shall be understood to be the intervention of the pharmacist in the development, revision, approval, and maintenance of standard operating procedures in connection with storage and distribution of medications as determined by the Secretary by regulation. One of the pharmacists shall be the head pharmacist. In the case of those enterprises engaged exclusively in the wholesale distribution of oxygen and any other medical gas, these may select as a staffing requirement either an authorized pharmacist or a certified chemist.
(c) They shall meet the requirements to be established by regulation and pay the corresponding fees. Likewise, they shall have in effect all permits, licenses and authorizations required under any other law in relation to the use of structures, facilities or premises of the establishment in which the activity for which a license is applied for is conducted and those required by any other laws to carry out said activity.
(d) All wholesaler drugstores and wholesale prescription medication distributors, as well as their officials, agents, representatives and employees shall meet prescription medication storage, management, and distribution register keeping requirements as provided under the federal law known as the Prescription Drug Marketing Act of 1987 and the regulations promulgated under this chapter.
(e) Wholesaler drugstores and distributors who distribute medications with special dispensation requirements shall meet Commonwealth and federal requirements concerning their management.
(f) Wholesaler drugstores, pharmaceutical industries and wholesale medication distributors shall distribute medications only to those establishments that are duly authorized by and registered with the Secretary to acquire, sell, administer or dispense said medications.
History —Sept. 3, 2004, No. 247, § 5.07; Dec. 14, 2007, No. 208, § 2.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter V - Manufacture, Distribution and Dispensation of Medications (§§ 410 — 410o) › § 410g - Representing agent

Any person representing a manufacturer or drug distributor who is not engaged in the storage or distribution of these in Puerto Rico, shall apply to and obtain from the Secretary a license that accredits him/her as a representing agent of said manufacturer or distributor. He/she shall be the person authorized to and responsible for requesting and obtaining the register of the medications the manufacturer or distributor markets and distributes in Puerto Rico.
History —Sept. 3, 2004, No. 247, § 5.08.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter V - Manufacture, Distribution and Dispensation of Medications (§§ 410 — 410o) › § 410h - Retail nonprescription medication distributor

Any retail nonprescription medication distributor shall apply for and obtain a license authorizing him/her to sell nonprescription drugs as provided for in this chapter and its regulations. Together with the application for the register certificate, a listing of the nonprescription medications he/she distributes shall be included.
Said medications shall be kept and sold in their original packages, duly labeled by the manufacturer, and shall be kept in an environment and at a temperature which are appropriate for preserving their quality, purity and potency, pursuant to the manufacturer’s specifications.
History —Sept. 3, 2004, No. 247, § 5.09.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter V - Manufacture, Distribution and Dispensation of Medications (§§ 410 — 410o) › § 410j - Drug cabinets

(a) Any person who keeps a drug cabinet shall apply to and obtain from the Secretary, one of the following licenses:
(1) Institutional drug cabinet license. — For all drug cabinets located in homes for the elderly, resting homes, dispensaries in factories, at-home health services institutions, penal institutions or similar establishments, whereby medications may be acquired and kept, to be administered solely and exclusively to patients at said institutions, or in the case of at-home health services institutions, to be administered to the patient at home, of which the dispatch or delivery for further use by patients is hereby prohibited.
(2) Medical office drug cabinet license. — For all drug cabinets located in physicians’, dentists’ or podiatrists’ offices, whereby medications may be acquired and kept, to be administered solely and exclusively to patients at said office, as may be necessary in the normal course of the professional practice for the prevention, diagnosis, treatment, relief or management of the patient’s condition, of which the dispatch or delivery for further use by patients is hereby prohibited, except for medical samples in their original package and with the original labeling, as identified by the manufacturer.
(3) Ambulance drug cabinet license. — For all drug cabinets located in Category III ambulance stations, whereby medications may be acquired and kept as necessary, to be administered solely and exclusively to patients as immediate treatment during an emergency, by physician’s orders, or by following the established medical treatment protocols.
(4) Educational institution drug cabinet license. — For all drug cabinets located in higher education institutions, whereby medications may be acquired and kept as necessary to be used solely and exclusively in teaching or research.
(b) Together with the application for a drug cabinet license, the following documents shall be submitted, as applicable:
(1) A copy of the medical professional’s license, a professional registration certificate, and a specialty certificate issued by the corresponding examining board.
(2) A copy of the higher education institution accreditation documents.
(3) A list of the medications to be kept in the drug cabinet and the amounts necessary in agreement with the normal course of the professional practice, the physician’s specialty or the kind of institution, being it understood that these medications are to be acquired pursuant to that which is provided in this chapter.
(c) No prescriptions shall be filled and no medications shall be repackaged at the drug cabinets. Medications are to be kept in their original packages with labeling either by the manufacturer or by the pharmacy which dispensed the same as required by law.
History —Sept. 3, 2004, No. 247, § 5.11.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter V - Manufacture, Distribution and Dispensation of Medications (§§ 410 — 410o) › § 410k - Veterinary facility

(a) For the operation of any veterinary facility, a license to be known as the “veterinary facility license”, shall be obtained from the Secretary. This license authorizes the holder to acquire and keep the medications necessary for veterinarians with their base in said facility to render professional services as authorized under §§ 2951—2969 of this title.
(b) The veterinary facility shall meet requirements such as occupancy permits, municipal license, and any other set forth by the applicable laws and regulations.
(c) The veterinary facility shall be under the charge of a veterinarian, who shall be responsible for ensuring the strict compliance with the measures needed for the adequate preservation, administration and dispatch of medications and devices used at said facility.
History —Sept. 3, 2004, No. 247, § 5.12.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter V - Manufacture, Distribution and Dispensation of Medications (§§ 410 — 410o) › § 410l - Retail veterinary medication distributor

(a) Any person engaged in the retail sale or distribution of veterinary medications which do not require a prescription shall apply to and obtain from the Secretary of Health a license as retail veterinary nonprescription medication distributor. Provided, That the Secretary of Health, by regulation and in consultation with the Secretary of Agriculture, shall establish the norms, requirements, controls and procedures that shall govern the consideration of an application that any natural or juridical person (conducting business as agricultural supply stores, transporters, for example) may submit in order to obtain a veterinary prescription medication distributor. This license authorizes the holder to sell veterinary prescription medications only when a veterinarian’s order has been received. None of the provisions herein shall authorize said person to sell or distribute veterinary products classified as “controlled substances” under the provisions of §§ 2101 et seq. of Title 24, known as the “Puerto Rico Controlled Substances Act”. The College of Pharmacists of Puerto Rico, the College of Veterinarians of Puerto Rico, and the Office of Drug Control of Puerto Rico may investigate any complaint and ensure strict compliance with the laws in effect relative to the sale of veterinary prescription medications in Puerto Rico. The Department of Health shall establish, by regulation, an adequate mechanism for the management and processing of said veterinarian’s orders, ensuring that the integrity and the safety of the human food chain are not compromised.
The Secretary shall adopt, by regulation, the requirements for obtaining licenses, as well as the norms, controls and procedures for the retail distribution of veterinary nonprescription medications.
Provided, That any person engaged in the commercial dealing of veterinary medications in Puerto Rico may, at the time of approval of this act, continue engaged therein for a maximum term of two (2) years from the date of approval of this act. Once said term has elapsed, he/she shall cease said practice, except in the event he/she is granted the corresponding license under the terms of this chapter.
History —Sept. 3, 2004, No. 247, § 5.13.
2023 Laws of Puerto Rico › TITLE TWENTY - Examining Boards and Professional Colleges (§§ 1 — 6033) › Chapter 20 - Pharmacy (§§ 407 — 412c) › Subchapter V - Manufacture, Distribution and Dispensation of Medications (§§ 410 — 410o) › § 410m - Devices

The Secretary shall adopt, by regulation, the norms, controls and procedures for the manufacture, distribution, sale, and dispensation of devices.
History —Sept. 3, 2004, No. 247, § 5.14.