Over-the-counter (OTC) drugs are medicines sold directly to a consumer
without a prescription from a healthcare professional, as opposed
to prescription drugs, which may only be sold to consumers possessing
a valid prescription. In many countries, OTC drugs are selected by a
regulatory agency to ensure that they are ingredients that are safe
and effective when used without a physician's care. OTC drugs are
usually regulated by active pharmaceutical ingredients (APIs), not
final products. By regulating APIs instead of specific drug
formulations, governments allow manufacturers freedom to formulate
ingredients, or combinations of ingredients, into proprietary
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. 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.
2 Regulation by country
2.4 United States
2.4.1 Restricted over-the-counter substances
2.5 United Kingdom
3 Switches between prescription and OTC
4 See also
6 External links
As of 2011, around a third of older adults in the U.S. reportedly used
OTC drugs. By 2018, the prevalence of use by adults in the U.S. as
first-line treatment for minor illnesses had reached 81%.
Regulation by country
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. 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
All medications other than Schedule 1 may be considered an OTC drug,
as they do not require prescriptions for sale. While the National
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.
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. 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.
In the Netherlands, there are four categories:
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.
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
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.
Federal Trade Commission
Federal Trade Commission regulates advertising of OTC products, in
contrast to prescription drug advertising, which is regulated by the
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.
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
Methcathinone or any active/scheduled analogs of
Phenylethylamines/ amphetamine." 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. 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.
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.
In the United Kingdom, medication is governed by the Medicines
Medication falls into one of three
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 sildenafil (Viagra) and 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
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'
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
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.
Switches between prescription and OTC
As a general rule, over-the-counter drugs have to be used primarily to
treat a condition that does not require the direct supervision of a
doctor and must be proven to be reasonably safe and well tolerated.
OTC drugs are usually also required to have little or no abuse
potential, although in some areas drugs such as codeine are available
OTC (usually in strictly limited formulations or requiring paperwork
or identification to be submitted during purchase).
Over time, often 3–6 years, drugs that prove themselves safe and
appropriate as prescription medicines may be switched from
prescription to OTC. An example of this is diphenhydramine (Benadryl),
an anti-histamine which once required a prescription but now is
available OTC nearly everywhere. More recent examples are cimetidine
and loratadine in the United States, and ibuprofen in Australia.
It is somewhat unusual for an OTC drug to be withdrawn from the market
as a result of safety concerns, rather than market forces, though it
does happen occasionally. For example, phenylpropanolamine was removed
from sale in the
United States over concern regarding strokes in young
women. A study has been done examining consumer's perceptions about
the risk of and access to nonprescription medication. A substantial
minority of the public appears willing to accept considerable risk to
gain greater access to pharmaceuticals.
In the United Kingdom, it was announced in February 2007 that Boots
the Chemist would try over-the-counter sales of Viagra in stores in
England (previous available as prescription only). Men
aged between 30 and 65 could buy four tablets after a consultation
with a pharmacist.
Generally recognized as safe and effective
Inverse benefit law
Regulation of therapeutic goods
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^ Over-the-Counter Medicines: What's Right for You?. Fda.gov
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^ "National Drug Schedules - Overview". National Association of
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^ "National Drug Scheduling Advisory Committee". National Association
Pharmacy Regulatory Authorities. Retrieved 16 August 2015.
^ CBG-MEB Drug database
^ Regulation of Nonprescription Drug Products Fda.gov. Retrieved on
^ The New Over-the-Counter Medicine Label: Take a Look. Fda.gov
(2012-04-27). Retrieved on 2012-07-04.
^ FDA Approves Plan B One-Step Emergency Contraceptive; Lowers Age for
Obtaining Two-Dose Plan B Emergency Contraceptive without a
Prescription. Fda.gov. Retrieved on 2012-07-04.
^ FDA Approves Over-the-Counter Access for Plan B for Women 18 and
Older. Fda.gov (2009-04-30). Retrieved on 2012-07-04.
^ "Medicines information". NHS Choices. Retrieved 19 September
^ Availability of medicines. MHRA. Retrieved on 2012-07-04.
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^ "Over-the-counter Viagra piloted". BBC News. 2007-02-11. Retrieved
Complete list of OTC drugs
"Over-the-Counter Medicines Guide", Tool Box at ConsumerMedSafety.org
"The Tan Sheet", the weekly source of OTC industry news in the US
OTC Product News, comments on news and events affecting the OTC
Over-the-counter (OTC) medicines at FamilyDoctor.org, maintained by
the American Academy of Family Physicians. Contains extensive
information on over-the-counter drugs and their responsible use,
including specific guidance on several drug classes in
question-and-answer format and information on common drug
UK Medicines and Healthcare Products Regulatory Agency list of
substances on general sales list
National Institute on Drug Abuse: "NIDA for Teens: Cough and Cold