P.R. Laws tit. 20, § 410o

2019-02-20 00:00:00+00
§ 410o. Granting, denial, suspension, cancellation or revocation of licenses, certificates or authorizations

(a) The Secretary is hereby conferred the exclusive power to grant, deny, suspend, cancel or revoke any of the licenses, certificates or authorizations required under this subchapter.

(b) The Secretary may suspend, cancel or revoke a license, a certificate or an authorization of any establishment engaged in the manufacture, distribution, dispensation and sale of medications or veterinary medications or of any drug cabinet when it is determined that:

(1) It does not meet the requirements and conditions provided for in this chapter and its regulations or in any other law of Puerto Rico or the United States which applies in terms of the management, control, preservation, distribution and dispensation of medications, devices and veterinary products.

(2) It is guilty of a violation of any law that applies in terms of the manufacture, distribution and dispensation of medications in Puerto Rico.

(3) It is operating without the presence and supervision of a pharmacist in cases which so require.

(4) It dispenses prescription medications without the direct or immediate supervision of a pharmacist.

(5) It refuses repeatedly and without justification to take certain measures or to correct any deficiency observed by inspector pharmacists.

(c) The Secretary shall direct the closedown of establishments who have had a license, certificate or authorization suspended, cancelled or revoked, and of those operating without a license, certificate or authorization as required by this chapter.

(d) Any procedure to grant, deny, suspend, cancel or revoke licenses, certificates or authorizations shall be governed by the provisions on adjudicative procedures established in §§ 2101 et seq. of Title 3, better known as the “Uniform [Administrative] Procedures Act”.

History —Sept. 3, 2004, No. 247, § 5.16.