S.L. 458.62 Art. 7Responsibilities of managing pharmacist. 3

(1) The managing pharmacist shall be responsible for:

(a) the preparation and dispensing of the medicinal FROM DESIGNATED PREMISES AT CENTRAL

PROCUREMENT AND SUPPLIES UNIT (CPSU) products as provided by all applicable legislative and standard requirements;

(b) ensuring that products exposed to the ambient (removed from their primary packaging) containing hormones or hormone derivatives or analogues are prepared using isolator technology;

(c) ensuring that products exposed to the ambient (removed from their primary packaging) containing cytotoxic active ingredients, derivatives or analogues are not handled as part of these authorised activities;

(d) ensuring that all medicinal products used are medicinal products authorised to be placed on the market in Malta and must be sourced from authorised suppliers;

(e) handling of products requiring refrigeration should be adequately validated.

(2) The managing pharmacist shall abide by all duties and obligations pertaining to managing pharmacists in pharmacies, as prescribed by the Act and any regulations or rules made thereunder, and for standards and conditions issued by the Authority from time to time in relation to pharmacies.

(3) The managing pharmacist must ensure that all operations and activities comply with PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010), where applicable, as determined by the Authority.