P.R. Laws tit. 20, § 411b
(a) The Secretary may delegate the function of overseeing compliance with the provisions of Subchapter V of this chapter, as well as any other related functions, to the Medication and Pharmacy Division, attached to the Office of the Deputy Secretary for Health Facility Regulation and Accreditation.
(b) The Secretary shall appoint a pharmacist with not less than five (5) years professional experience to direct the overseeing functions of the Medication and Pharmacy Division and shall have an adequate number of inspector pharmacists to perform, among others, the following functions:
(1) To examine records, documents, inventories, property, physical facilities, premises, transactions, business or any other materials or activities relative to the manufacture, distribution, and dispensation of medications subject to the provisions of this chapter.
(2) To recall or seize any unregistered medication pursuant to this chapter, or any medication not fit for consumption.
(3) To compile the evidence necessary for the prosecution of violators of this chapter and the regulations thereunder, in order for these to be prosecuted at the corresponding administrative or judicial forum.
(4) To summon witnesses, take oaths, and certify declarations or other documents.
(c) Any document whose examination is pertinent under the provisions of this chapter and which is relative to the manufacture, importation, distribution, purchase, dispensation, sale or vending of medications in Puerto Rico, shall be available for inspection by the Secretary. Likewise, any person holding a license, certificate or authorization under this chapter, shall facilitate any inspection as required by the Secretary. The fact that the owner or main manager is not present at the establishment shall not be cause or justification to prevent said inspection from being conducted, but the Secretary shall establish by regulation a reasonable maximum term within which any document required during the inspection which was not available at the time, is to be made available for examination. In those cases in which validly obtained documents are not to be used pursuant to that which is provided in this chapter, these shall be returned to their owner or legal custodian from whom they were obtained. Documents obtained under this chapter shall be classified as confidential, unless their use is allowed by law.
(d) The Medication and Pharmacy Division shall notify the Board of Pharmacy of those violations of this chapter and its regulations incurred by pharmacists and pharmacy technicians. Likewise, it shall notify the College of Pharmacists of Puerto Rico of the violations incurred by pharmacists.
History —Sept. 3, 2004, No. 247, § 6.03.