AUTHORISATION FOR DISPENSING AND DELIVERY TO PATIENTS OF PARENTERAL NUTRITION SOLUTIONS AND AMBULATORY DIALYSIS SOLUTIONS FROM PREMISES OTHER THAN A PHARMACY [ S.L.458.56 1 SUBSIDIARY LEGISLATION 458.56 AUTHORISATION FOR DISPENSING AND DELIVERY TO PATIENTS OF PARENTERAL NUTRITION SOLUTIONS AND AMBULATORY DIALYSIS SOLUTIONS FROM PREMISES OTHER THAN A PHARMACY RULES 28th June, 2012 LEGAL NOTICE 222 of
- The title of these rules is the Authorisation for Dispensing and Delivery to Patients of Total Parenteral Nutrition Solutions and Am bulat ory Di alysi s So lut ions from Prem ises oth er t han a Pharmacy Rules. Citation.
- Total Parenteral Nutrition Solutions and Ambulatory Dialysis Solutions, which are classified as medicinal products, hereafter referred to as infusion solutions, shall not be dispensed from premises other than a pharmacy unless there is an authorisation issued by the Licensing Authority and subject to such conditions set by the said Authority. Dispensing of infused solutions. 3.
(1)An authorisation shall not be granted unless there is a written request by the applicant addressed to the Licensing Authority. Granting of authorisation.
(2)All details of the intended operations shall be submitted, including: (
- a)the name and address of the applicant; (
- b)the address of the premises that are to be used for such purpose and the details of the means of transportation to be used to deliver these infusion solutions up to patient level; (
- c)the equipment and control facilities, both in the premises and in the transport systems used particularly if cold storage is needed; (
- d)information, documentation or evidence to prove that the premises and transport systems used are suitable and adequate, and that there are suitable facilities, installations and equipment so as to ensure proper conservation, particularly if cold storage is needed, and dispensing of the infusion solutions; (
- e)the name and address of a managing pharmacist who shall be professionally responsible for all activities including storage, transportation and delivery up to patient; (
- f)any other information, documentation or evidence as may be requested by the Licensing Authority. 2 [ S.L.458.56 Dispensing and delivery. Conditions of authorisation. AUTHORISATION FOR DISPENSING AND DELIVERY TO PATIENTS OF PARENTERAL NUTRITION SOLUTIONS AND AMBULATORY DIALYSIS SOLUTIONS FROM PREMISES OTHER THAN A PHARMACY 4. The authorisation shall only cover the dispensing and delivery of these infusion solutions together with other infusion fluids and ancillary medical equipment and devices used in total parenteral nutrition and dialysis, herein after referred to as "ancillary items", from such site as is indicated therein. 5. Such authorisation shall: (
- a)not be transferable; (
- b)be issued for a period of one year unless renewed. Duty of the managing pharmacist. 6.
(1)It shall be duty of the managing pharmacist to ensure: (
- a)the procuring and sourcing of these infusion solutions together with their ancillary items from licensed wholesale dealers, and their adequate storage, dispensing and delivery to the patient; and (
- b)that the dispensing and where applicable, delivery to the patient of these infusion solutions together with their ancillary items, shall always be against a valid prescription: Provided that in those cases where delivery is effected by a person other than the managing pharmacist, the responsibility shall still vest with such managing pharmacist, unless such a delivery is contracted out to a wholesale dealer in which case the responsible person of the wholesale dealer shall be responsible for the integrity of these products during their delivery to the patient.
(2)The managing pharmacist shall follow any criteria and conditions for the dispensing and transportation of these infusion solutions as may be laid down by the Licensing Authority from time to time. Powers of the Licensing Authority. 7. The Licensing Authority shall have the right to amend, suspend or revoke any authorisation if: (
- a)any matter stated in the application on which the authorisation was issued is found to be false or incomplete; (
- b)a material change of circumstances has occurred in relation to any of those matters; (
- c)any provision or condition of the authorisation have been contravened by the authorisation holder or by the managing pharmacist; (
- d)any other circumstance occurs as established by or under the Act.