P.R. Laws tit. 20, § 410i

2019-02-20 00:00:00+00
§ 410i. Pharmacy

(a) All pharmacies shall apply to and obtain from the Secretary a license authorizing them to operate as such, including the acquisition, sale or dispensation of medications or devices, pursuant to the provisions of this chapter. This license shall allow them to participate in any modality of health services rendered in Puerto Rico.

(b) To obtain a pharmacy license, a pharmacy shall:

(1) Comply with the norms and procedures as the Secretary determines by regulation to be necessary for the protection of the public health, safety and welfare, which shall include, without it being construed as a limitation, the following:

(A) Safety measures for medication management and storage.

(B) Minimal equipment and reference books or electronic reference materials that it should have in order to render pharmaceutical services.

(C) Procedures for the transfer or disposal of medications, prescriptions, patient pharmacy records and other documents at the time the pharmacy is under new management or closes its operations.

(D) It shall have the services of at least one (1) pharmacist while open to the public and designate a head pharmacist, regardless of whether he/she is the only pharmacist working in the pharmacy, who shall be in charge of and responsible for the pharmacy counter.

(E) It shall have the permits required for the use of structures or buildings and other indispensable public services, as well as any municipal license, license, permit or authorization required under other laws for the operation of a pharmacy establishment or for the sale of certain products.

(F) It shall reserve and keep a physical space for the dispensation of prescription drugs, to be known as the pharmacy counter. The pharmacy counter area shall be designed, built and organized in such a manner so as to allow for patients to receive confidential orientation and the closing thereof in the event the pharmacist is absent. The Secretary shall determine the minimum physical facility requirements that such an area must meet. The pharmacy counter area shall be restricted to the personnel authorized by law to dispense prescription medications, without limiting the pharmacy owner’s or administrator’s entrance for limited periods of time to carry out necessary administrative functions.

(c) All pharmacies shall be serviced whenever it is open to the public by the pharmacists and pharmacy technicians as necessary to provide safe and adequate pharmacy services. The pharmacist may be absent only in case of an emergency. During said absence, a sign shall be posted so that it is visible, so as to inform the public of said absence. For the duration of said absence, no prescription medications shall be dispensed and the pharmacy counter shall be closed to the public.

(d) A pharmacist may supervise in terms of the dispensation of medications, during the same shift, not more than five (5) pharmacy technicians, or one (1) pharmacy intern or pharmacy technician intern and four (4) pharmacy technicians, for a maximum of five (5) persons to be under his/her supervision. Under the pharmacist’s direct supervision, pharmacy interns may discharge any of the pharmacist’s functions. Pharmacy technician interns may discharge technical and administrative functions which do not require a pharmacist’s professional judgment, requiring the direct supervision of the latter to discharge functions relative to the dispensation of prescriptions as allowed for pharmacy technicians under § 407d of this title. Direct supervision shall be understood to be the physical presence of the pharmacist at the pharmacy counter area or the immediate workspace, and the personal review of the task completed. In the event the intern is a student enrolled in supervised practice courses at an accredited school of pharmacy, the criteria and standards established by the Board by regulation for those cases, shall apply. Pharmacy technicians, or pharmacy technician interns or pharmacy interns who perform tasks not relative to the dispensation of medications shall not count for the four person maximum to be under the pharmacist’s supervision.

(e) Pharmacy counter personnel shall be duly identified so that the public may easily distinguish the pharmacist, the pharmacy technician, the pharmacy intern, and the pharmacy technician intern from one another.

(f) As of the date of effectiveness of this act, no physician, medical group, whether under a professional corporation or partnership, pharmacy benefits administrator or health insurance company may refer or direct patients to specific pharmacies, thus guaranteeing the patient’s right to free selection. Likewise, no pharmacy may establish a contractual relation or a negotiation which promotes or allows this practice.

Any patient or his/her designated person, whose right to free selection of pharmacy has been violated by the persons or entities abovementioned in this subsection, may file a complaint before the Secretary of Health against such entity or person who incur such violation, subject to the jurisdiction of the Department and the application of the adjudicative regulations of the agency.

(g) Institutional pharmacies shall meet the requirements established in §§ 331 et seq. of Title 24, and the regulations adopted thereunder and comply with the applicable provisions of this chapter.

(h) No pharmacy may falsely advertise the offering of a pharmaceutical service defined in this chapter.

History —Sept. 3, 2004, No. 247, § 5.10; Nov. 16, 2009, No. 138, § 4.