Pharmacy Council or FDA: who regulates a pharmacy in Ghana?

If you plan to open a pharmacy in Tema or a chemical shop in a village near Techiman, you will deal with two regulators. People often mix them up. In short: the Pharmacy Council decides who may run which kind of medicine business, and where. The Food and Drugs Authority (FDA) decides which products may be sold at all.

Everything below comes from the regulators' own websites and published guidelines, read in October 2026. The Council says it may amend its guidelines without notice, and this article does not cover fees. Treat it as a map, and get the current details from the regulator.

Who regulates what?

The Pharmacy Council regulates pharmacy practice and premises; the FDA regulates products. The Council says it is established under Parts IV and VI of the Health Professions Regulatory Bodies Act, 2013 (Act 857). Among its functions it lists to "ensure the equitable and accessible distribution of pharmaceutical premises" and to "monitor and inspect pharmacy practices". The FDA says it draws its mandate from Parts 6, 7 and 8 of the Public Health Act, 2012 (Act 851), and regulates food, drugs, cosmetics, medical devices, household chemicals and other products.

What is the difference between a pharmacy and a chemical shop?

A pharmacy may supply all classes of medicines under a registered pharmacist; an over-the-counter medicine seller, often called a licensed chemical seller, may sell only class C, over-the-counter medicines, by retail.

The Council's Pharmacy Business Application Guidelines (version 03, issued 10 March 2025) describe three classes:

• Class A: prescription-only medicines.
• Class B: the pharmacist's list, medicines a pharmacist may supply without a prescription.
• Class C: over-the-counter preparations.

The guidelines say all pharmacies "should be supervised by registered Pharmacists in good standing". The Council's guidelines for over-the-counter medicine practitioners say the licence is issued under Section 94 of Act 857 and authorises the retail supply of "ONLY over-the-counter medicines (i.e. class C or OTC medicines)" at the premises named on it. They also list its limits: it is for the holder only, at one specified location, for class C medicines only, and by retail only.

The same guidelines warn that a seller who is not a pharmacist must not use a name or title implying a pharmacist's qualification, and quote Section 110 of Act 857 on opening premises described as a "pharmacy, dispensary, chemist, drug store" without a registered pharmacist supervising.

What do the Council's guidelines say about opening a pharmacy?

According to the 2025 guidelines, a registered company that has employed a registered pharmacist applies online, the Council inspects the proposed site, and an approved applicant is given up to six months to prepare the premises for a final inspection.

1. 1Apply online with the forms and Registrar-General documents
2. 2Council confirms receipt and checks the application
3. 3Site inspection of the proposed location
4. 4Written decision; up to six months to prepare the premises
5. 5Final inspection against the guidelines and FDA storage rules
6. 6Pay the registration fee; certificate issued

A few requirements from the same document:

• The proposed superintendent pharmacist must have at least 12 months of post-registration practice in Ghana and be employed full-time for that pharmacy.
• A retail pharmacy needs at least 36 square metres of floor space and a ceiling of at least 3.2 metres, including a customer area, dispensary, office and counselling area.
• The distance from other retail facilities is "guided by accessibility to the facilities, population and distance criteria (400m radius)".
• The final inspection follows the Council's guidelines and the FDA's guidelines on Good Storage and Distribution Practices.

What do the guidelines say about a chemical shop licence?

The Council's over-the-counter guidelines say the applicant must be a Ghanaian citizen with at least GCE O Level, an SSS certificate or equivalent, and must not be a recognised prescriber. The licence is meant to provide some level of pharmaceutical services in deprived areas, so the guidelines say approval will not be granted in regional or district capitals, towns, cities and areas with existing pharmacies. In villages and rural areas, a new shop should be at least 1 km from the nearest licensed over-the-counter medicine facility.

• 36 m²Minimum floor space, retail pharmacy
• 12 m²Minimum floor space, OTC medicine shop
• 31 JanRenewal deadline for both licences
• 1 kmDistance from the nearest OTC shop in rural areas

Source: Pharmacy Council Ghana, application guidelines for pharmacies (2025) and OTC medicine practitioners

The guidelines say the licence expires on 31 December each year and should be renewed by 31 January. It cannot be transferred to another place or another person; that is treated as a fresh application. Operating with an expired licence, using another person's licence, or moving without the Council's authorisation are listed as offences.

What does the FDA cover?

The FDA covers the products. Its Drug Registration and Inspection division says it grants market authorisation for allopathic medicines intended for sale on the Ghanaian market, and its remit runs to herbal medicines, vaccines, food supplements, medical devices, cosmetics and household chemicals.

For a shop owner, three FDA tools matter:

1. The product register. The FDA website links to a public search of registered products. Check new lines there, especially from a supplier you do not know.
2. Safety Watch. The FDA runs a platform for reporting adverse reactions.
3. Alerts. Check the news and alerts on the FDA website for warnings about products.

The Council's guidelines also list the "display and supply of expired, unregistered, fake and substandard medicines" among offences, so the two regulators' rules meet on your shelf.

What records do the regulators expect?

The Council's guidelines make the superintendent pharmacist responsible for ensuring "records are duly and properly kept", and list "improper record keeping on the procurement and supply of restricted drugs" among offences. They also say class A medicines are supplied only on prescription. Ask the Council exactly which registers and records apply to your premises.

A POS helps with the commercial side: purchases from each supplier, sales, stock and batches. It is not a substitute for regulatory records. MPOS does not keep prescription records or a controlled-drugs register, and does not do NHIS or insurance claims. Keep those in the form your regulator requires.

Where do you check the current rules?

Go to the regulator. The Pharmacy Council's website has its guidelines, online applications for pharmacies and over-the-counter medicine sellers, licence renewal, and a search of licensed practitioners and facilities. The FDA website has the product register, Safety Watch and its alerts. Fees are set by the regulators and change, so ask them for the current figure.

What to do next

If you are opening, download the current guidelines from the Council and read them before you sign a lease: location and floor space rules come first. If you are already licensed, put the 31 January renewal date in your calendar now.

When the paperwork is in order, the daily work is stock, cash and expiry. The complete guide to running a pharmacy in Ghana covers it, and tracking expiry dates and batches is a good place to start.