Dispensing and Labeling Medicines Flashcards
MR 41
Form of prescription
Every prescription given under these regulations shall—
(a)
be legibly and indelibly printed; and
(b)
be signed personally by the prescriber with his usual signature (not being a facsimile or other stamp), and dated; and
(c)
set out the following information in relation to the prescriber:
(i)
the prescriber’s full name; and
(ii)
the full street address of the prescriber’s place of work or, in the absence of the prescriber having a place of work, the postal address of the prescriber; and
(iii)
the prescriber’s telephone number; and
(d)
set out—
(i)
the surname, each given name, and the address of the person for whose use the prescription is given; and
(ii)
in the case of a child under the age of 13 years, the date of birth of the child; and
(e)
indicate by name the medicine and, where appropriate, the strength that is required to be dispensed; and
(f)
indicate the total amount of medicine that may be sold or dispensed, or the total period of supply; and
(g)
if the medicine is to be administered by injection, or by insertion into any cavity of the body, or by swallowing, indicate the dose and frequency of dose; and
(h)
if the medicine is for application externally, indicate the method and frequency of use; and
(i)[Revoked]
(j)
in the case of a prescription relating to the treatment of an animal,—
(i)
set out the surname, each given name, and the address of the owner of the animal; and
(ii)
contain the following statement, or words of similar meaning:
“Not for human use”.
MR 42
Dispensing of prescription medicines
1 - Except as provided in subclause (2), no person other than an authorised prescriber, veterinarian, pharmacist, pharmacy graduate, a pharmacy technician, a student, or dispensary technician may dispense a prescription medicine.
(1A)
The following persons may not dispense prescription medicines unless under the direct personal supervision of a pharmacist
dispensary technicians:
pharmacy graduates:
pharmacy technicians:
students.
(2)
An agent or employee of a veterinarian may, in any particular case, dispense any prescription medicine at the direction of the veterinarian for use in the treatment of any animal under the care of the veterinarian.
(3)
Every person dispensing a prescription relating to a prescription medicine must comply with the following requirements:
(a)
if the prescription has been communicated orally under regulation 40A(1), the prescription must not be dispensed on more than 1 occasion before the pharmacist has received the written confirmation of the prescription, as required by regulation 40A(2):
(b)
the following information must be recorded on the prescription:
(i)
the name and address of the proprietor of the business at which the prescription is dispensed; and
(ii)
the date on which the prescription is dispensed; and
(iii)
the quantity of medicine dispensed; and
(iv)
a unique identifying number or code for the prescription:
(c)
a prescription for a medicine other than an oral contraceptive must not be dispensed on any occasion after 6 months have elapsed from the date on which it was printed or, if given under regulation 40A(1), communicated orally:
(d)
a prescription for a medicine that is an oral contraceptive must not be dispensed on any occasion after 9 months have elapsed from the date on which it was printed or, if given under regulation 40A(1), communicated orally:
(e)
every prescription must be retained for a period of 3 years by the pharmacist on the premises on which it was dispensed or at a place approved by the Medical Officer of Health and must be kept in an orderly and consecutive manner so as to be readily available for inspection.
(4)
If an authorised prescriber or a veterinarian refers in a prescription to a medicine by its trade mark or trade name, or by reference to the name of its manufacturer, a pharmacist may supply an alternative brand of medicine, provided that—
(a)
the authorised prescriber or veterinarian has not marked the prescription “No brand substitution permitted” or with words of similar meaning; and
(b)
the substituted brand contains the same active ingredient or active ingredients, and no other active ingredients; and
(c)
the substituted brand is in the same dose form and strength as the prescribed brand; and
(d)
there is no clinical reason why the substituted brand should not be supplied; and
(e)
the pharmacist records the brand substitution on the prescription; and
(f)
the pharmacist signs and dates the prescription; and
(g)
the pharmacist informs the patient of the brand substitution.
MR 43
DG may waive certain requirements
(1)Despite the requirements in regulations 41 and 42, the Director-General may, at his or her discretion,—
(a)
authorise a form of prescription that does not comply with all or any of the requirements in regulation 41, but that is subject to any other requirements that he or she thinks fit; and
(b)
authorise the dispensing of prescription medicines in a manner that does not comply with all or any of the requirements in regulation 42, but that is subject to any other requirements that he or she thinks fit.
(2)
A form of prescription that may be authorised under subclause (1)(a) includes, but is not limited to, an electronic form of prescription.
MR 44
Prescriptions for prescription medicines not required in certain cases
A prescription medicine may be sold or dispensed otherwise than under a prescription given by a practitioner, registered midwife, veterinarian, or designated prescriber if it is sold to or dispensed for—
(a)
a person licensed to sell the prescription medicine by wholesale; or
(b)
a person obtaining the prescription medicine for use in any process of manufacture or trade not involving the resale of the medicine; or
(c)
an analyst under the Act, or a person approved by the Director-General and in charge of a laboratory maintained for the purposes of research, study, or analysis; or
(d)
a hospital care operator within the meaning of section 58(4) of the Health and Disability Services (Safety) Act 2001; or
(e)
a pharmacist in control of any pharmacy, or any dispensary in a hospital care institution within the meaning of section 58(4) of the Health and Disability Services (Safety) Act 2001; or
(f)
an authorised prescriber or veterinarian; or
(g)
a patient under his or her care by an authorised prescriber; or
(h)
a patient under the care of an authorised prescriber, provided that—
(i)
the medicine is administered by a person who has been instructed by the authorised prescriber (either verbally or in writing) to do so; and
(ii)
the person administering the medicine records the administration in the patient’s medical record; and
(iii)
the authorised prescriber records the instruction under subparagraph (i) in the patient’s medical record; or
(i) the master of a New Zealand ship within the meaning of the Maritime Transport Act 1994,
(ia)
the master of a foreign ship within the meaning of the Maritime Transport Act 1994, if the law of the State whose flag the ship is entitled to fly requires the master to carry the medicine; or
(j)
a person for inclusion in an emergency medical kit kept or to be kept for use in any vessel to which paragraph (i) does not apply, and is so sold or dispensed pursuant to an order signed by a Medical Officer of Health; or
(k)
the person in charge of an aircraft if the medicine is required to be carried on the aircraft as a condition of the issue of a certificate of airworthiness; or
(l)
a person for inclusion in an emergency medical kit pursuant to an order signed by a Medical Officer of Health for use in a place of a class approved by the Director-General; or
(m)
a person who has previously been supplied with the medicine on the prescription of an authorised prescriber for a particular condition, and is so sold or dispensed—
(i)
by a pharmacist who is satisfied that the person requires an emergency supply of the medicine for that condition; and
(ii)
in an amount not exceeding the quantity reasonably required by that person for a period of 72 hours, or a minimum pack of a special container from which it is not practicable to dispense a lesser amount; or
(n)
any person by a veterinarian for the treatment of an animal under the care of the veterinarian; or
(o)
a person or body authorised to distribute, or a person authorised to administer, the prescription medicine in an approved immunisation programme.
MR 44A
Administration of vaccines in approved immunisation programmes
(1)
Any medical practitioner or other person who is authorised by the Director-General or a Medical Officer of Health in accordance with this regulation to administer, for the purposes of an approved immunisation programme, a vaccine that is a prescription medicine, may, in carrying out that immunisation programme, administer that prescription medicine otherwise than pursuant to a prescription.
(2)
The Director-General or a Medical Officer of Health may authorise any person to administer a vaccine for the purposes of an approved immunisation programme if that person, following written application, provides documentary evidence satisfying the Director-General or the Medical Officer of Health, as the case may be, that that person—
(a)
can carry out basic emergency techniques including resuscitation and the treatment of anaphylaxis; and
(b)
has knowledge of the safe and effective handling of immunisation products and equipment; and
(c)
can demonstrate clinical interpersonal skills; and
(d)
has knowledge of the relevant diseases and vaccines in order to be able to explain the vaccination to the patient, or to the parent or guardian of the patient who is to consent to the vaccination on behalf of the patient, to ensure that the patient or the parent or guardian of the patient can give informed consent to the vaccination.
(3)
shall be valid for a period of 2 years and shall be subject to such conditions as the Director-General or the Medical Officer of Health, as the case may be, thinks fit.
(4)
An authorisation given to any person under subclause (2) may be withdrawn at any time before its expiry if the Director-General or a Medical Officer of Health is satisfied that the authorised person has failed to comply with any condition specified by the Director-General or the Medical Officer of Health under subclause (3).
MR 44B
Duty to supply information
(1)
The Medical Officer of Health may require any authorised prescriber to supply information relating to the prescribing, administering, or supplying of any prescription medicines if the Medical Officer of Health has reason to suspect that prescription medicines may have been improperly prescribed, administered, or supplied by the authorised prescriber.
(2)
Every requirement to supply information must be in writing, stating the reasons for the Medical Officer of Health’s suspicion.
(3)
The information that must be supplied is information justifying the prescription, administering, or supply of the prescription medicines as follows:
(a)
the age of the patient:
(b)
the diagnosis of the patient’s condition:
(c)
the prognosis of the patient’s condition:
(d)
details of any specialist referral:
(e)
any alternative treatments considered or tried.
(4)
An authorised prescriber to whom any such notice is sent must supply the required information in writing to the Medical Officer of Health within 30 days.
MR 63
Restriction on, and supervision of, compounding medicine
(1)
A dispensary technician must not undertake any process of compounding a medicine.
(2) The following persons may compound a medicine, but only if under the direct personal supervision of a pharmacist: (a) pharmacy graduates: (b) pharmacy technicians: (c) students: (d) despite subclause (1), dispensary technicians who have served an apprenticeship in pharmacy under the Pharmacy Act 1939.
MR 12
Medicines, related products, and medical devices not to be sold unless properly labelled
(1)
No person shall sell any medicine or related product in a container if the container—
(a)
does not bear a label containing all the particulars required by these regulations to be on a label relating to such a container; or
(b)
bears a label containing anything that is prohibited by these regulations from appearing on a label relating to such a container; or
(c)
bears a label containing any particulars that are not in the position, manner, and style required by these regulations in respect of a label relating to such a container.
(2)
No person shall sell a package containing a single container of any medicine or related product unless that package is labelled in a manner similar to that in which the container is labelled.
(3)
No person shall sell any medicine in a poison bottle bearing any label that obscures any flutings, ribs, nettings, points, embossed words, or similar markings on the bottle.
(4)
No person shall sell any medical device that does not bear the name of the manufacturer of the medical device or the name of the manufacturer’s distributor in New Zealand.
(5)
Notwithstanding anything in the foregoing provisions of this regulation, the Director-General may, by notice in writing to the manufacturer or importer of any medicine, exempt from the labelling requirements of these regulations the sale of that medicine in a container of a specified type.
MR 13
Labelling medicines
(1)
Every container of a medicine must, unless otherwise provided by these regulations, bear a label containing the following information:
(a)
the trade name of the medicine or, if there is no trade name, the appropriate designation of the medicine:
(b)
the name of each active ingredient:
(c)
the appropriate quantitative particulars of each active ingredient:
(d)
a description of the medicine, including dose form, or presentation, that indicates the true nature of the medicine:
(e)
a statement of the net weight or volume or number of the contents of the container, as the case may require:
(f)
in the case of a prescription medicine,—
(i)
the words “PRESCRIPTION MEDICINE” or words of a similar meaning; or
(ii)
the words “PRESCRIPTION-ONLY MEDICINE” or words of a similar meaning; or
(iii)
the acronym “POM”:
(g)
in the case of a restricted medicine,—
(i)
the words “RESTRICTED MEDICINE”; or
(ii)
the words “PHARMACIST-ONLY MEDICINE”:
(h)
in the case of a pharmacy-only medicine,—
(i)
the words “PHARMACY-ONLY MEDICINE” or words of a similar meaning; or
(ii)
the words “PHARMACY MEDICINE” or words of a similar meaning:
(i)
any warning statement required by these regulations for the medicine:
(j)
in the case of a medicine other than a prescription medicine, a statement of the purpose for which the medicine is intended to be used:
(k)
in the case of a medicine sold, or intended for sale, for external use,—
(i)
a statement of directions for use and frequency of use; and
(ii)
the words “Caution: not to be taken”, or “For external use only”, or words of a similar meaning:
(l)
in the case of a medicine sold, or intended for sale, for internal use,—
(i)
the dose recommended; and
(ii)
the frequency of that dose:
(m)
the words “Batch Number” or “Lot Number”, or the word “Batch” or “Lot”, or the letter “B” (either alone or inside a circle) followed by the batch or lot number of the medicine:
(n)
the words “Use by” or “Use before”, or words of a similar meaning, followed by the expiry date (being in no case later than 5 years after the date of manufacture of the medicine) appropriate to the stability of the medicine:
(o)
where appropriate, a statement of the recommended storage conditions:
(p)
the name and address of—
(i)
the manufacturer or seller of the medicine; or
(ii)
the owner of the rights of manufacture; or
(iii)
the agent of any person who comes within subparagraph (i) or (ii).
(2)
For the purposes of subclause (1)(p),—
(a)
an address at a post office is not sufficient:
(b)
the name and address of a person not ordinarily resident in New Zealand are not sufficient unless the medicine is wholly manufactured and packed outside New Zealand:
(c)
in the case of a body corporate registered in New Zealand, the name of the town in which the body corporate has its registered office is sufficient.
(3)
In the case of a medicine intended for administration only in accordance with the directions of a practitioner, it is sufficient compliance with subclause (1)(l) to indicate the dose by a range if the container is accompanied by a more specific statement relating to each usage.
(4)
In the case of a prescription medicine, compliance with the requirements of subclause (1)(k) or (l) is required only at the time at which that medicine—
(a)
is sold by retail; or
(b)
is supplied in circumstances corresponding to retail sale; or
(c)
is supplied by way of gift or sample for the purpose of promoting a sale.
(5)
Subclause (1)(l) does not apply in the case of a medicine intended to be administered by or under the supervision of a practitioner, in circumstances where the dosage is to be dependent on concurrent skilled observation.
(6)
Every container of a medicine that is prepared for injection into the human body and that contains an antiseptic or preservative must be labelled with a statement of the nature and amount of the antiseptic or preservative.
(7)
Every container of a medicine that is a biochemical preparation must, in addition to the other requirements in this regulation, bear a label containing the following:
(a)
a statement of the potency of the preparation; and
(b)
a statement of the nature and amount of every antiseptic or preservative (if any) used in the medicine.
(8)
Where it is impractical to put all of the information required by this regulation on a label because the container is too small, it is sufficient compliance with this regulation to print the information required by subclause (1)(i), (j), and (o) on a separate information sheet, in the same manner as that information would be required by these regulations to be printed on a label, and to supply that sheet to the customer with the medicine.
MR 14
Labelling of related products
(1)
Every container of a related product must, unless otherwise provided by these regulations, bear a label containing the following information:
(a)
the trade name of the related product or, if there is no trade name, the appropriate designation of the related product:
(b)
the name of each active ingredient:
(c)
the appropriate quantitative particulars of each active ingredient:
(d)
a description of the related product that indicates the true nature of the related product:
(e)
a statement of the net weight or volume or number of the contents of the container, as the case may require:
(f)
any warning statement required by these regulations for the related product:
(g)
in the case of a related product sold, or intended for sale, for external use,—
(i)
a statement of directions for use and frequency of use; and
(ii)
the words “Caution: not to be taken”, or “For external use only”, or words of a similar meaning:
(h)
in the case of a related product sold, or intended for sale, for internal use,—
(i)
the dose recommended; and
(ii)
the frequency of that dose:
(i)
the words “Batch Number” or “Lot Number”, or the word “Batch” or “Lot”, or the letter “B” (either alone or inside a circle) followed by the batch or lot number of the related product:
(j)
where appropriate, an expiry date:
(k)
the name and address of—
(i)
the manufacturer or seller of the related product; or
(ii)
the owner of the rights of manufacture; or
(iii)
the agent of any person who comes within subparagraph (i) or (ii).
(2)
For the purposes of subclause (1)(k),—
(a)
an address at a post office is not sufficient:
(b)
the name and address of a person not ordinarily resident in New Zealand are not sufficient unless the related product is wholly manufactured and packed outside New Zealand:
(c)
in the case of a body corporate registered in New Zealand, the name of the town in which the body corporate has its registered office is sufficient.
MR 15
Exemptions from regulations 13 and 14
(1)
(a)
a container that—
(i)
contains a single dose of a medicine or related product; and
(ii)
is made of sheet material; and
(iii)
is not attached to another container; and
(iv)
is contained in a package that complies with regulation 13 or 14 (as the case requires); and
(v)
is not intended for sale other than in that package:
(b)
a container that—
(i)
contains a single dose of a medicine or related product; and
(ii)
is not made of sheet material; and
(iii)
has a volume of 20 millilitres or less; and
(iv)
is contained in a package that complies with regulation 13 or 14 (as the case requires); and
(v)
is not intended for sale other than in that package:
(c)
a container (other than an aerosol container) that—
(i)
contains a medicine or related product that is a gas; and
(ii)
is of a kind commonly used for storing or transporting gases in compressed, liquefied, or dissolved form; and
(iii)
has a capacity not exceeding 250 litres water capacity:
(d)
a container of a remedy that is, or is described as, homeopathic.
(2)
Nothing in regulation 13 or 14 applies to a strip of containers that—
(a)
is made of sheet material; and
(b)
bears the information required by—
(i)
regulation 13(1)(m) and (n) or regulation 14(1)(i) and (j) (as the case requires) at least once on the strip; and
(ii)
regulation 13(1)(a), (b), and (c) or regulation 14(1)(a), (b), and (c) (as the case requires)—
(A)
at least once in relation to every 2 containers, if the containers are easily detached from the strip; and
(B)
at least once on the strip in any other case; and
(c)
is contained in a package that complies with regulation 13 or 14 (as the case requires); and
(d)
is not intended for sale other than in that package.
(3)
In this regulation, strip of containers means a series of containers that each contain a single dose of a medicine or related product and that together form a strip.
(4)
Nothing in regulation 13(1)(f), (g), or (h) applies to a prescription medicine, restricted medicine, or pharmacy-only medicine, held for sale by a manufacturer or wholesaler, for the period of 3 months immediately following the date on which it becomes a prescription medicine, restricted medicine, or pharmacy-only medicine (as the case may be) if, at that date, the medicine was part of the existing stock-in-trade in New Zealand of the manufacturer or wholesaler.
(5)
Nothing in regulation 13(1)(f), (g), or (h) applies to a prescription medicine, restricted medicine, or pharmacy-only medicine, held for sale by a retailer, for the period of 6 months immediately following the date on which it becomes a prescription medicine, restricted medicine, or pharmacy-only medicine (as the case may be) if, at that date, the medicine was part of the existing stock-in-trade in New Zealand of the retailer.
(6)
For the purposes of subclauses (4) and (5), any goods purchased before the date on which a substance becomes a prescription medicine, restricted medicine, or pharmacy-only medicine (as the case may be) for importation into New Zealand are deemed to be part of the purchaser’s stock-in-trade in New Zealand.
MR 16
Principal display panel
(1)
The principal display panel of the label of a medicine must contain—
(a)
the information required by regulation 13(1)(a), (d), and (e); and
(b)
the information required by regulation 13(1)(b) and (c), but only if the medicine contains 3 or fewer active ingredients.
(2)
Subclause (1) is subject to regulation 23.
(3)
The principal display panel of the label of a related product must contain—
(a)
the information required by regulation 14(1)(a), (d), and (e); and
(b)
the information required by regulation 14(1)(b) and (c), but only if the related product contains 3 or fewer active ingredients.
(4)
Nothing in subclause (1) or (3) prevents the inclusion in the principal display panel of any other matters required by these regulations to appear on a label of any medicine or related product.
(5)
Subclause (4) is subject to regulation 19.
MR 17
Form and manner of labelling
(1)
Subject to subclause (4), every label that is required by these regulations to be borne on a container shall—
(a)
be conspicuously written in English and, for each statement separately required, be in a colour or colours contrasting strongly with the statement’s background; and
(b)
be legibly and durably marked either on the material of the container or on material firmly and securely attached to the container; and
(c)
be of such nature and material that it will not fade to the extent of becoming illegible, or become detached, by the influence of—
(i)
light; or
(ii)
atmospheric humidity or dryness; or
(iii)
normal atmospheric temperatures; or
(iv)
recommended storage temperatures; or
(v)
the contents of the container; and
(d)
be of such a nature and in such a position that it will not readily be defaced in the course of normal handling and use; and
(e)
be in such a position that it is not damaged, defaced, destroyed, or removed when the container is opened; and
(f)
not be obscured by any other label, folder, or pamphlet.
(2)
The lettering of the words required by these regulations shall be clear, distinct, and legible, with no decoration, embellishment, or distortion that could interfere with the legibility of the words.
(3)
Every label that is required by these regulations to appear on a container shall, if the medicine or related product is sold otherwise than in a container, appear on the medicine or related product.
(4)
It shall be sufficient compliance with subclause (1) if the particulars required by paragraphs (d) and (e) of regulation 13(1) are embossed conspicuously on the container of the medicine.
MR 18
Size of letters
(1)
A minimum size of lettering used on labels that is prescribed by these regulations refers to the height of capital letters, or lower case letters with an ascender or descender, in the typeface used.
(5)
Subject to subclause (6) and except as otherwise expressly permitted by any of the provisions of these regulations, the lettering of words required by these regulations to appear on labels shall be not less than 1.5 millimetres in height.
(6)
Where words are required by these regulations to appear on labels in letters of a specified size, and the container to be labelled is so small as to prevent the use of letters of that size, letters of a smaller size may be used if they are of the largest size practicable in the circumstances and are in any event no smaller than 0.75 millimetres.
MR 19
Labelling of prescription medicines, restricted medicines and pharmacy only
Where a label on a container is required by these regulations to bear—
(a)
the words “PRESCRIPTION MEDICINE” or words of a similar meaning; or
(b)
the words “PRESCRIPTION ONLY MEDICINE” or words of a similar meaning; or
(c)
the acronym “POM”; or
(d)
the words “RESTRICTED MEDICINE”; or
(e)
the words “PHARMACIST ONLY MEDICINE”; or
(f)
the words “PHARMACY-ONLY MEDICINE” or words of a similar meaning; or
(g)
the words “PHARMACY MEDICINE” or words of a similar meaning,—
the words or acronym, as the case may require, shall be placed prominently and legibly on the label.
