P.R. Laws tit. 20, § 410f

2019-02-20 00:00:00+00
§ 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.