P.R. Laws tit. 20, § 410
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.