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Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a

prescription from a healthcare professional,[1] as opposed to prescription drugs,


which may be sold only to consumers possessing a valid prescription. 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. OTC drugs are usually regulated according to their active pharmaceutical
ingredient (API) rather than final products. By regulating APIs instead of specific
drug formulations, governments allow manufacturers the freedom to formulate
ingredients, or combinations of ingredients, into proprietary mixtures.[2]

The term over-the-counter may be somewhat counterintuitive, since, in many


countries, these drugs are often placed on shelves in self-service areas of stores,
like any other packaged products.[1] In contrast, prescription drugs are almost
always passed over a counter from the pharmacist to the customer. 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 the
provision of patient education. In many countries, a number of OTC drugs are
available in establishments without a pharmacy, such as general stores,
supermarkets, and gas stations. 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.[3]

Canada
In Canada, there are four drug schedules:[5]

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. 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.[6] 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.
[1] Prior to this, the general assumption was that any drug which did not fall into
a prescription schedule could be purchased without a prescription.[1] However, the
needed definition had not been enacted by early 2018. The lack of a legal
definition for OTC drugs has led to this US$4 billion market segment being
effectively unregulated.[1]

Netherlands
In the Netherlands, there are four categories:[7]

UR (Uitsluitend Recept): prescription only


UA (Uitsluitend Apotheek): pharmacist only
UAD (Uitsluitend Apotheek of Drogist): pharmacist or drugstore only
AV (Algemene Verkoop): can be sold in general stores
A drug that is UA can 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,
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. 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.[8]

United States
In the United States, the manufacture and sale of OTC substances is 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.[9]

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.[10]

Restricted over-the-counter substances


An ill-defined third category of substances is products having over-the-counter
status from the FDA while being simultaneously subject to other restrictions on
sale. While they are legally classified as OTC drugs, they are typically stored
behind the counter and are sold only in stores that are registered with their
state. They may be unavailable in convenience and grocery stores that stock other
non-restricted OTC medications.

For example, many drugstores have moved products containing pseudoephedrine, an OTC
product, into locations where customers must ask a pharmacist for them. A
prescription is not required; the change has been made in an effort to reduce
methamphetamine production. Since the passage of the Illinois Methamphetamine
Precursor Control Act and the subsequent federal Combat Methamphetamine Epidemic
Act of 2005, the purchase of pseudoephedrine is restricted. Sellers of
pseudoephedrine must obtain and record the identity of the purchaser and enforce
quantity restrictions. Some states may have more stringent requirements (such as
Oregon, where a medical prescription is required to purchase any quantity of
pseudoephedrine). After initial attempts to control methamphetamine use (by
requiring documentation of sale with government issued ID as well as limits on the
quantity an individual could purchase) failed to realize meaningful reductions in
methamphetamine use and production, Mississippi passed House Bill 512 in the State
Senate on February 2, 2010 "to require a prescription from a licensed medical
professional to purchase over-the-counter medicines with pseudoephedrine,
ephedrine, or any other precursor chemical that can readily and illicitly be
converted into methamphetamine, Methcathinone or any active/scheduled analogs of
Phenylethylamines/ amphetamine."[citation needed] However, products containing the
substance are still OTC in most states, since no prescription is required.

A similar regulation applies to some forms of emergency contraception. The FDA


considers them to be OTC substances for females 17 or over but prescription drugs
for younger women.[11] To enforce the restriction and to provide counseling and
education on proper use, an agreement between the manufacturer and the FDA requires
the drugs are stored behind the pharmacy counter. Women may obtain the medication
without a prescription after providing proof of age to pharmacy staff and receiving
any necessary patient education.[12]

Furthermore, some Schedule V controlled substances may be classified as OTC


products in certain states. Such drugs are sold without a prescription but are
subject to record-keeping rules and quantity and/or age restrictions, and they must
be dispensed by a pharmacy.

United Kingdom
In the United Kingdom, medication is governed by the Medicines Regulations 2012.
Medication falls into one of three categories:[1][13]

Prescription Only Medication (POM), which are 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. Just a small example of these include most antibiotics
and all antidepressants or antidiabetic medications. Drugs included as POM are
high-strength painkillers such as oxycodone and tramadol, medications such as
Zolpidem (Ambien), diazepam (Valium), and certain topical preparations such as
corticosteroids. These medicines are often sold by drug dealers, especially those
marked as "CD POM," which are controlled due to abuse risk such as dipipanone,
temazepam, and methadone.
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 and ibuprofen as well
as a host of other safe medications such as small pack sizes of antiallergy
tablets, laxative medication, and skin creams.
Pharmacy Medicines (P) are medicines which are legally neither a POM or GSL
medication. These can be sold from a registered pharmacy 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. Suitable 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 Nytol, 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 two WHAM questions must be followed "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.[14]