Regulation 4 Pharmacy procedures

(1)

The matters which must be covered by pharmacy procedures are—

(a)

the arrangements to secure that medicinal products are—

(i)

ordered;

(ii)

stored;

(iii)

prepared;

(iv)

sold by retail^f1;

(v)

supplied in circumstances corresponding to retail sale^f2;

(vi)

delivered outside the pharmacy; and

(vii)

disposed of

in a safe and effective manner;

(b)

the circumstances in which a member of pharmacy staff who is not a pharmacist may give advice about medicinal products;

(c)

the identification of members of pharmacy staff who are, in the view of the responsible pharmacist, competent to perform certain tasks relating to the pharmacy business;

(d)

the keeping of records about the arrangements mentioned in paragraph (a);

(e)

the arrangements which are to apply during the absence of the responsible pharmacist from the premises;

(f)

the steps to be taken when there is a change of responsible pharmacist at the premises;

(g)

the procedure which is to be followed if a complaint is made about the pharmacy business;

(h)

the procedure which is to be followed if an incident occurs which may indicate that the pharmacy business is not running in a safe and effective manner; and

(i)

the manner in which changes to the pharmacy procedures are to be notified to pharmacy staff.

(2)

Pharmacy procedures must be recorded—

(a)

in writing;

(b)

in electronic form; or

(c)

in both forms.

(3)

Pharmacy procedures must be available at the premises for inspection by—

(a)

the person carrying on the pharmacy business;

(b)

the superintendent, if any^f3;

(c)

the responsible pharmacist; and

(d)

pharmacy staff.

(4)

Pharmacy procedures must be reviewed regularly.

(5)

In this regulation, “pharmacy procedures” means the procedures referred to in section 72A(3) of the Act.

Annotations

Footnotes

f1: See section 131(3) of the Act for the meaning of “sold by retail”.
f2: See section 131(4) of the Act for the meaning of “supplied in circumstances corresponding to retail sale”.
f3: Section 71 is substituted by the Health Act 2006, section 28(1). Subsection (1)(a) of section 71 requires that a business which is carried on by a body corporate is under the management of a superintendent pharmacist.