The Board of Assessors flags pharmacy law as the domain GPhC CRA candidates most consistently underperform in. Candidates know the clinical therapeutics — that maps to MPharm training. Law requires applying specific UK regulations to clinical scenarios under exam conditions — a different skill from knowing the principles.
This guide covers every major law topic the exam tests.
Medicines Classification
POM (Prescription-Only Medicine): Requires a valid prescription from an appropriate practitioner. Most medicines are POM. Supply without a prescription is illegal except under specific legal exemptions (emergency supply, PGD).
P (Pharmacy Medicine): Can be sold without a prescription but only from a registered pharmacy under the supervision of a pharmacist. The pharmacist must be satisfied the supply is appropriate. Examples: higher-strength ibuprofen, chloramphenicol eye drops.
GSL (General Sale List): Can be sold from any retail outlet — no pharmacy supervision required. Examples: 16-tablet paracetamol packs, small-quantity aspirin.
Misuse of Drugs Act 1971 and Regulations 2001
Schedule 1: Drugs with no accepted medical use in the UK (LSD, cannabis — though cannabis-based products for medicinal use are now Schedule 2, MDMA, raw opium). Possession and supply require a Home Office licence.
Schedule 2 (CD POM): Full controlled drug requirements. CD register entry mandatory. Safe custody mandatory. CD prescription requirements apply (dose in words and figures, form, strength, total quantity in words and figures). Examples: morphine, diamorphine, fentanyl, oxycodone, methylphenidate, amphetamine, cocaine, cannabis-based products for medicinal use.
Schedule 3 (CD No Register POM): CD prescription requirements apply (same as Schedule 2). Safe custody required (with exceptions: temazepam and midazolam are Schedule 3 but exempt from safe custody). No CD register entry required. Examples: tramadol, buprenorphine, midazolam, temazepam, gabapentin, pregabalin.
Schedule 4 Part I: Benzodiazepines (except temazepam and midazolam — Schedule 3). No CD prescription requirements. No safe custody. No CD register.
Schedule 4 Part II: Anabolic steroids, growth hormone. No CD prescription requirements.
Schedule 5: Low-strength CD preparations. Can be supplied OTC in some cases (e.g., codeine linctus <1.5%).
CD Prescription Requirements
A valid controlled drug prescription (Schedules 2 and 3) must include: the prescriber's address, date, patient name and address, the form of the preparation, the strength (where appropriate), the dose, the total quantity in both words and figures, and the prescriber's signature. Electronic prescribing of Schedule 2 and 3 CDs is now permitted in England — the EPS requirements replace the handwriting requirement, but all other elements must still be present.
Validity: CD prescriptions are valid for 28 days from the appropriate date (the date specified on the prescription or, if none, the date of signing).
Responsible Pharmacist Regulations 2008
Every registered pharmacy must have a named Responsible Pharmacist (RP) during opening hours. The RP must make a record (RP record) including their name, registration number, date and time of assuming responsibility. The RP can be absent for up to 2 hours during their RP period — provided pharmacy procedures are in place and the absence is planned. During absence, sale and supply of medicines under the supervision of a non-pharmacist is restricted.
PGDs vs PSDs
Patient Group Direction (PGD): A written instruction allowing specified healthcare professionals to supply and/or administer specified medicines to patients meeting defined clinical criteria — without an individual prescription. Used for: NHS vaccination programmes, Pharmacy First, emergency hormonal contraception supply. PGDs must be signed by a doctor or dentist and a pharmacist, and approved by the relevant NHS body.
Patient Specific Direction (PSD): A written instruction from a prescriber for a specific named patient. More flexible than a prescription but less formal than a PGD.
Emergency Supply
At the request of a patient: The pharmacist must interview the patient. The medicine must have been previously prescribed. It must be immediately necessary and impracticable to obtain a prescription. Maximum supply: 30 days for most POMs; 5 days for Schedule 4/5 CDs; specific quantities for antibiotics and other short courses. Schedule 2 and 3 CDs cannot be supplied on emergency supply at the request of a patient.
At the request of a prescriber: Broader provisions. The prescriber must undertake to provide a prescription within 72 hours. Schedule 2 and 3 CDs can be supplied on emergency supply at the request of a prescriber (unlike patient request).
GPhC Standards for Pharmacy Professionals
All 9 standards must be known. They cover: person-centred care, professional knowledge, working with others, safeguarding, speaking up, professional behaviour, education and CPD, leadership, and confidentiality. Ethics questions in Part 2 present scenarios requiring you to identify which standard applies and what the correct professional response is.
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