GMP information for manufacturers of compounded medicines and DAAs

The holding of a manufacturing licence and the inclusion of therapeutic goods in the ARTG are separate matters.

Persons engaged in the manufacture of therapeutic goods in Australia must generally either hold a TGA issued manufacturing licence or be exempt from the requirement. In addition, before therapeutic goods may be imported, exported, manufactured or supplied in Australia, they must be included in the ARTG, unless the goods are exempt under one of the exemptions provided for under the legislation.

Schedule 8 of the Therapeutic Goods Regulations 1990 - external site provides exemptions from the requirement to hold a manufacturing licence. Item 2 of Schedule 8 of the Therapeutic Goods Regulations 1990 is relevant to compounding by community pharmacists. Item 2 exempts pharmacists from the requirement to hold a manufacturing licence in certain circumstances. For example, when therapeutic goods (other than biologicals) are (i) produced by the pharmacist in a pharmacy where the pharmacist practices and the pharmacy is open to the public and (ii) the goods are supplied (other than by wholesale) on or from those premises.

Schedules 5 and 5A of the Regulations provide exemptions from the requirement to include therapeutic goods in the ARTG in particular circumstances. Item 6 of Schedule 5 of the Regulations is relevant to compounding by pharmacists. This item provides an exemption from the requirement for therapeutic goods to be included in the ARTG where the goods are dispensed or extemporaneously compounded for a particular person for therapeutic application to that person.

Yes, if the medicine is extemporaneously compounded for an identified person for therapeutic application to that person.

Yes, provided that the medicine has been extemporaneously compounded for a particular person for therapeutic application to that person.

No, such medicines would usually need to be included in the ARTG in relation to the person manufacturing and supplying the medicine.

No. A pharmacist may be exempt from the requirement to include a medicine in the ARTG where it is extemporaneously compounded for a particular person for therapeutic application to that person. A pharmacist should therefore ensure that there is an identified person for whom the medicine is being compounded before undertaking any steps in manufacture. Pharmacists are not permitted to store excess quantities of compounded medicines in case additional prescriptions are subsequently presented by patients. (For further details, please refer to the Pharmacy Board of Australia Guidelines on compounding of medicines - external site.)

The Pharmacy Board of Australia Guidelines on compounding of medicines includes requirements in relation to batch preparation. In relation to TGA requirements, the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990 do not specifically deal with batch preparation. If a TGA licensed manufacturer is relying on the exemption in item 6 of Schedule 5 (relating to extemporaneous compounding) to manufacture and supply a medicine that is not included in the ARTG, the manufacturer will need to ensure that there is an identified person for whom a medicine is being compounded at the time of the compounding. Manufacture may proceed in anticipation of an order where the TGA licensed manufacturer holds evidence that the identified patient is undergoing a defined course of treatment.

No, there is not a limited form of a manufacturing licence for pharmacists to compound and dispense medicines. However, there are exemptions from the requirement to hold a manufacturing licence that will apply to pharmacists in certain circumstances. For example, a pharmacist is exempt from the requirement to hold a manufacturing licence to manufacture therapeutic goods (excluding biologicals) when the goods are produced in a pharmacy where the pharmacist practices and which is open to the public and supplied (other than by wholesale) on or from those premises.

Generally yes but the exemption in the Therapeutic Goods Regulations that allows for this has certain requirements, the main ones being that there are no substantially similar goods included in the ARTG and that the medicine is manufactured in accordance with a formulation specified by the hospital.

No, a community pharmacy would not normally be considered a public institution under the therapeutic goods legislation.

Yes. Product Quality Reviews are performed to demonstrate the consistency of the manufacturing process. Where no Marketing Authorisation is available, clauses 1.10.vi and 1.10.x do not apply, but a review of the process consistency, including all other elements of clause 1.10 should be performed and documented by the manufacturer.

Persons engaged in the manufacture of therapeutic goods in Australia are generally required to hold a manufacturing licence. There are, however, some circumstances in which a person is exempt from the requirement to hold a manufacturing licence. The exemptions are set out in Schedules 7 and 8 of the Therapeutic Goods Regulations 1990 - external site. Whether an exemption applies depends on the circumstances of the particular manufacture.

Item 2 of Schedule 8 provides an exemption to pharmacists from the requirement to hold a licence for the manufacture of therapeutic goods if:

1. the goods are not:
   1. biologicals.
2. the goods are produced by the pharmacist:
   1. in a pharmacy where the pharmacist practices and the pharmacy is open to the public; or
   2. on the premises of a dispensary conducted by a Friendly Society; or
   3. on the premises of a private hospital; and
   4. the goods are for supply (other than by wholesale) on or from those premises.

Item 3 of Schedule 8 provides an exemption to biomedical engineers, radiochemists and pharmacists in public hospitals from the requirement to hold a manufacturing licence for:

'the manufacture of therapeutic goods, other than biologicals, by the person when employed by a public hospital or a public institution and produced by that person for supply in hospitals or public institutions in the same state or territory'

Therapeutic goods manufactured in Australia are generally required to be listed or registered on the Australian Register of Therapeutic Goods (ARTG). There are, however, some specific circumstances where the goods may be exempt from the requirement to be listed or registered. The exemptions are set out in Schedules 5 and 5A of the Therapeutic Goods Regulations 1990 - external site. Whether an exemption applies depends on the circumstances of the particular manufacturing activities.

Item 6 of Schedule 5 which provides an exemption for:

medicines that are dispensed, or extemporaneously compounded, for a particular person for therapeutic application to that person, other than:

1. medicines that are used for gene therapy.

Item 5 of Schedule 5A which provides an exemption for:

Therapeutic goods, if:

1. the goods are not any of the following:
   1. biologicals;
   2. goods referred to in item 3;
2. the goods are manufactured by a person under a contract between the person and a private hospital, a public hospital in a State or Territory or a public institution (the relevant institution); and
3. the manufacture is in accordance with a formulation specified by the relevant institution; and
4. the goods are for use by, or in connection with, a patient of:
   1. the relevant institution; or
   2. if the relevant institution is a public hospital in a State or Territory - another public hospital in the State or Territory where:
      1. there are no listed goods or registered goods that, in all relevant respects, are substantially similar to the goods; and
      2. the person:
         1. manufactures the goods at premises in Australia; and
         2. holds a licence, required by the Act, that authorises the manufacture, or a step in the manufacture, of the goods at those premises; and
      3. the person notifies the Secretary, in accordance with a form approved by the Secretary and within 15 days of the end of a quarter, of:
         1. the goods manufactured under the contract during that quarter; and
         2. the relevant institution that entered the contract

Where permitted by applicable state and territory legislation, a pharmacist may engage the services of a third party to pack a DAA on their behalf (e.g. a TGA licensed facility or another pharmacy).

The supply pharmacist (who supplies the DAA to the patient or their agent):

• must ensure that the patient's right to privacy is understood, the patient or agent has consented if a third party is to be involved in the packing of the DAA, and a record of the consent is kept
• is responsible for ensuring the packing pharmacist has accurate details of the medicines to be packed
• must make an assessment of the measures, techniques and technology used by the packing pharmacist at the third party packing facility to check packed DAAs for accuracy, to determine whether additional checking of a DAA is required prior to its supply to a patient or their agent

AND

• is responsible for the quality use of medicines support for the patient, including provision of accompanying medicines information to the patient or their agent.

The direct supply of the DAA to the patient or their agent from the third-party packing facility is not permitted under the therapeutic goods legislation and must not take place, even if pharmacists are employed at that facility. It is the responsibility of the supply pharmacist to make the supply of the DAA to the patient or their agent.

A packing pharmacist who uses an automated or semi-automated dose packaging system on behalf of a supply pharmacist may need licensing by the TGA in jurisdictions that have laws to complement the Therapeutic Goods Act 1989. Please check the applicable laws in your state or territory.

When permitted by applicable state and territory legislation, a pharmacist may engage the services of a third party to pack a DAA on their behalf (e.g. a Therapeutic Goods Administration (TGA) licensed facility or another pharmacy).

The packing pharmacist at the third party packing facility is responsible for ensuring DAAs are prepared in a timely and accurate manner according to the patient's current medication regimen.

The direct supply of the DAA to the patient or their agent from the third-party packing facility is unlawful and must not take place, even if pharmacists are employed at that facility. It is the responsibility of the supply pharmacist to make the supply of the DAA to the patient or their agent.

A packing pharmacist who uses an automated or semi-automated dose packaging system on behalf of a supply pharmacist may need licensing by the TGA in jurisdictions that have laws to complement the Therapeutic Goods Act 1989.

• Where both pharmacies are in the same state and only trade in that state, and are not incorporated bodies, such as where one pharmacy contracts another to pack medicines into DAA packs and supply them only in the same state, then their operation may not come under the scope of Commonwealth law, thus will not require a GMP licence. However, the co-regulatory scheme requires those individual trading entities to comply with all state laws that will apply to them.
• Where the pharmacies are not in the same state (or are trading across state boundaries) then the operations would come under the scope of the Commonwealth law, and thus a GMP licence would be required.