Canada In
Canada, there are four drug schedules: • Schedule 1: Requires a prescription for sale and is 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. These drugs are kept in an area of the retail outlet where self-selection is possible, but a pharmacist must be available to assist in the self-selection of medication if required. • 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. While the National Association of Pharmacy Regulatory Authorities provides recommendations on the scheduling of drugs for sale in Canada, each province may determine its own scheduling. The drugs found in each schedule may vary from province to province.
India In November 2016, India's Drug Consultative Committee announced it was embarking on establishing a definition of drugs which could be dispensed without a prescription. Prior to this, the general assumption was that any drug which did not fall into a prescription schedule could be purchased without a prescription. • UR (Uitsluitend Recept): prescription only • UA (Uitsluitend Apotheek): pharmacist only • UAD (Uitsluitend Apotheek of Drogist): pharmacist or drugstore only • AV (Algemene Verkoop): may be sold in general stores A drug that is UA may be sold OTC but only by pharmacists. The drug can be on the shelves like any other product. Examples are
domperidone, 400 mg
ibuprofen up to 50 tablets and
dextromethorphan. A drug that is UAD can also be sold at drugstores which are stores where no prescription can be filled. The drugs are usually on the shelves, and the store also sells items like toys, gadgets, perfumes and homeopathic products. The drugs in this category have limited risk and addiction potential. Examples are
naproxen and
diclofenac in small amounts,
cinnarizine, 400 mg ibuprofen up to 20 tablets and also 500 mg
paracetamol up to 50 tablets. 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. The FDA requires that all "new drugs" obtain a
New Drug Application (NDA) before entering interstate commerce, but the act exempts any drugs
generally recognized as safe and effective (GRAS/E). To deal with the vast number of OTC drugs that were already on the market before the requirement that all drugs obtain an NDA, the FDA created the
OTC monograph system to review classes of drugs and to categorize them as GRAS/E after review by expert panels. Certain classes of OTC drugs would not be required to obtain an NDA and could remain on the market if they conformed to the monograph guidelines for doses, labeling, and warnings finalized in the
Code of Federal Regulations. Thus, an OTC drug product is allowed to be marketed either (1) pursuant to an FDA monograph or (2) pursuant to an NDA for products that do not fit within a specific monograph. There is also the possibility that certain OTC drug products are marketed under the grandfathering provisions of the
Federal Food, Drug, and Cosmetic Act, but the FDA has never formally acknowledged that any legitimate grandfathered OTC drug exists. Examples of OTC substances approved in the United States are sunscreens, anti-microbial and anti-fungal products, external and internal analgesics such as
lidocaine and
aspirin,
psoriasis and
eczema topical treatments,
anti-dandruff shampoos containing
coal tar, and other topical products with a therapeutic effect. The
Federal Trade Commission regulates advertising of OTC products, in contrast to prescription drug advertising, which is regulated by the FDA. The FDA requires OTC products to be labeled with an approved "Drug Facts" label to educate consumers about their medications. The labels comply to a standard format and are intended to be easy for typical consumers to understand. Drug Facts labels include information on the product's
active ingredient(s),
indications and purpose, safety warnings, directions for use, and
inactive ingredients. The 2020
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes reforms that modernize the way certain OTC drugs are regulated in the United States. Many OTC monographs need to be updated but updating or changing an OTC monograph requires the slow and burdensome notice-and-comment rulemaking process. • Prescription Only Medication (POM), which is legally available only with a valid prescription from a prescriber. A
pharmacist has to be on the premises for POM medicines to be dispensed, required by law. The medicine has been specifically prescribed for the patient holding the prescription, so it is considered safe for only the recipient to take. examples of these include most
antibiotics and all
antidepressants or
antidiabetic medications. Certain POM medicines are additionally marked Controlled Drug (CD) due to risk of abuse and the possibility of diversion for sale as street drugs. Examples of CDs include all
benzodiazepines and strong opioids such as
heroin and
fentanyl. • General Sales List (GSL), available off the shelf with no pharmacy training required to sell (so they can be sold anywhere, such as supermarkets). In general, they are considered safe for most people when taken correctly. Examples of these include 16-packs (or less) of painkillers such as
paracetamol,
ibuprofen, and
aspirin as well as a host of other medications such as small pack sizes of some
antihistamines, some
laxative medication, and skin creams. This also includes the
recreational substances
alcohol and
caffeine (where they are included in medicinal products), and some
nicotine preparations. • Pharmacy Medicines (P) are medicines that are legally neither a POM or GSL medication. These can be sold by pharmacies, with no requirement for a prescription, but should not be available for self-selection (although directions to discuss a 'P' product may be allocated shelf space with associated GSL items). 'P' medications are reserved from the GSL list as they are either associated with a need for advice on use, or used in conditions which may require referral to a medical prescriber. Suitably trained counter assistants may sell a 'P' medication under the supervision of a pharmacist and will ask questions to determine if the customer needs to be referred for a discussion with a pharmacist. Some 'POM' medicines are available for use in certain situations and doses as 'P' medicines. If it is not appropriate to sell a 'P' medication – i.e. the condition is not suitable for self-management and requires referral to a medical prescriber – then a sale should not occur and the pharmacist has a legal and professional obligation to refer this on to an appropriate service. Examples of these include some sleep aid tablets such as
diphenhydramine, human
deworming tablets such as
mebendazole, painkillers with small amounts of
codeine (up to 12.8 mg per tablet), and
pseudoephedrine. Medication available only with a prescription is marked somewhere on the box/container with [POM]. Pharmacy-only products are marked with [P]. A prescription is not required for [P] medicines, and pharmacy sales assistants are required by
Royal Pharmaceutical Society codes to ask certain questions, which varies for what the customer says. If they ask for a specific product, the pharmacy assistant must ask "Who is it for?", "How long have you had the symptoms?", "Are you allergic to any medication?", "Are you taking any medication?" ('WHAM' questions). If a customer asks for a remedy, e.g., hay fever, then the '2WHAM questions' must be asked "Who is it for?", "What are the symptoms?", "How long have you had the symptoms?", "Have you taken any action towards your symptoms?", and "Are you taking any other medication?". It is with this information that the pharmacist can halt the sale, if need be. No [POM], [P] or [GSL] products that are stocked in a pharmacy can be sold, dispensed, or pre-made until a responsible pharmacist is signed in and on the premises. Some medication available in supermarkets and petrol stations is sold only in smaller packet sizes. Often, larger packs will be marked as [P] and available only from a pharmacy. Frequently, customers buying larger-than-usual doses of [P] medicines (such as
DXM, promethazine, codeine or
Gee's Linctus) will be queried, due to the possibility of abuse. ==Transitions between prescription and OTC==