Patients may not legally extemporaneously compound a product that contains a Controlled Drug
The Royal Pharmaceutical Society has recently been made aware of a situation where a pharmacist had provided a patient with the raw ingredients (one of which was a Controlled Drug) to produce a medicinal product for his own use. The supply of these items was made against a lawful prescription. The patient had been combining (compounding) these items to prepare a final extemporaneous medicinal product for self-administration.
Under the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations
2001, as amended, only certain persons are lawfully permitted to compound
Controlled Drugs. Pharmacists are listed as persons who may carry out such
compounding. The Home Office has confirmed that a patient may not legally
compound and extemporaneously prepare a medicinal product that includes
a Controlled Drug even where the ingredients have been lawfully supplied
against a prescription, as to do so would be in breach of the legislation.
Pharmacists who choose to compound a Controlled Drug must ensure that they
act in accordance with the Code of Ethics and Section 4 of the “Professional
standards and guidance for the sale and supply of medicines” document.
They must also ensure that such activities are adequately covered by professional
indemnity insurance.
Alternatively, pharmacists may make arrangements for such a product to
be lawfully prepared by an appropriately licensed “specials” manufacturer.
Pharmacists must not provide patients with Controlled Drug ingredients
for them to mix together to produce a final product. |
The
Pharmaceutical Journal