Over-the-counter (OTC) Drugs and Different Countries Regulation

Over-the-counter (OTCdrugs are the medicines that can sold directly to a consumer without a prescription from a healthcare professional.

The term over-the-counter (OTC) refers to a medication that can be purchased without a medical prescription

Prescription Drugs are the medicines which may be sold only to consumers having a valid prescription.

Prescription drugs require a prescription from a doctor and should only be used by the prescribed individual.

In many countries OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician’s care.

Some drugs may be legally classified as over-the-counter (i.e. no prescription is required), but may only be dispensed by a pharmacist after an assessment of the patient’s needs or requirements.

Regulations detailing the establishments where drugs may be sold, who is authorized to dispense them, and whether a prescription is required vary considerably from country to country.

Different Counties Regulations for OTC Drugs:

Canada :

 In Canada, there are four drug schedules:

Schedule 1: Requires a prescription for sale and are provided to the public by a licensed pharmacist.

Schedule 2: Does not require a prescription but requires an assessment by a pharmacist prior to sale. These drugs are kept in an area of the pharmacy where there is no public access and may also be referred to as “behind-the-counter” drugs.

Schedule 3: Does not require a prescription but must be kept in an area under the supervision of a pharmacist.

Unscheduled: Does not require a prescription and may be sold in any retail outlet.

All medications other than Schedule 1 may be considered an OTC drug, as they do not require prescriptions for sale.

India :

In November 2016, India’s Drug Consultative Committee announced it was begin on establishing a definition of drugs which could be dispensed without a prescription.

Commonly used analgesics like paracetamol and ibuprofen and  medicines for cough, cold and flu fall under the OTC category. 

Netherlands :

A drug that is UA can be sold OTC but only by pharmacists.

A drug that is UAD can also be sold at drugstores, stores where no prescription can be filed and there is only a relatively small selection of popular drugs like painkillers and cough medicine.

The drugs are usually on the shelves, and the store also sells items like toys, gadgets, perfumes and homeopathic products.

Drugs in the AV category can be sold at supermarkets, gas stations etc. and include only drugs with minimal risk to the public, like paracetamol up to 20 tablets, 200 mg ibuprofen up to 10 tablets, cetirizine and loperamide.

United States :

In the United States, the manufacture and sale of OTC substances are regulated by the Food and Drug Administration.

Examples of OTC substances approved in the United States are anti fungal and  analgesics such as lidocaine,  aspirin,  eczema topical treatments, anti-dandruff shampoos and other topical products with a therapeutic effect.

The FDA requires OTC products to be labeled with an approved “Drug Facts” label to educate consumers about their medications. The labels include information on the product’s active ingredient(s), indications and purpose, safety warnings, directions for use, and inactive ingredients.

United Kingdom  :

Prescription Only Medication (POM), which are legally available only with a valid prescription from a prescriber and A pharmacist has to be on the premises for POM medicines to be dispensed, required by law.

General Sales List (GSL), available off the shelf with no pharmacy training required to sell (so they can be sold anywhere, such as supermarkets) and  In general, they are considered safe for most people when taken correctly.

Pharmacy Medicines (P) are medicines which are legally neither a POM or GSL medication and these can be sold from a registered pharmacy and a medical prescriber.

Examples of these include some sleep aid tablets such as  human deworming tablets such as Mebendazole, painkillers and pseudoephedrine.

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