AUTHORISATION FOR DISPENSING AND DELIVERY TO PATIENTS OF PARENTERAL NUTRITION SOLUTIONS AND AMBULATORY

AUTHORISATION FOR DISPENSING AND DELIVERY TO PATIENTS OF

PARENTERAL NUTRITION SOLUTIONS AND AMBULATORY DIALYSIS

SOLUTIONS FROM PREMISES OTHER THAN A PHARMACY

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 2012.

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.

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.

(1) An authorisation shall not be granted unless there is a

written request by the applicant addressed to the Licensing

Authority.

(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.

AUTHORISATION FOR DISPENSING AND DELIVERY TO PATIENTS OF

PARENTERAL NUTRITION SOLUTIONS AND AMBULATORY DIALYSIS

SOLUTIONS FROM PREMISES OTHER THAN A PHARMACY

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.

Such authorisation shall

(a) not be transferable;

(b) be issued for a period of one year unless renewed.

(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.

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.