Over-the-counter drug

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OTC Bayer medication with child-resistant packaging (cap) and tamper-resistant carton and innerseal Aspirin1.jpg
OTC Bayer medication with child-resistant packaging (cap) and tamper-resistant carton and innerseal
Photo of the packaging of four medicines dispensed in the United Kingdom showing their Product Licence Numbers and symbols denoting if they are Prescription Only Medicine (POM) or Pharmacy Medicine (P), or lacking either, denoting General Sales List (GSL). From top to bottom: mebendazole (P), amlodipine (POM), diazepam (POM), paracetamol (GSL). PLcodes.jpg
Photo of the packaging of four medicines dispensed in the United Kingdom showing their Product Licence Numbers and symbols denoting if they are Prescription Only Medicine (POM) or Pharmacy Medicine (P), or lacking either, denoting General Sales List (GSL). From top to bottom: mebendazole (P), amlodipine (POM), diazepam (POM), paracetamol (GSL).

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, [1] as opposed to prescription drugs, which may be supplied 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]

Contents

The term over-the-counter (OTC) refers to a medication that can be purchased without a medical prescription. [3] In contrast, prescription drugs require a prescription from a doctor or other health care professional and should only be used by the prescribed individual. [4] 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. 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.

Usage

As of 2011, around a third of older adults in the U.S. reportedly used OTC drugs, and this number is increasing. [5] [6] [7] [8] By 2018, the prevalence of use by adults in the U.S. as first-line treatment for minor illnesses had reached 81%: however, there is some debate as to whether this figure relates to an actual improvement of health. [9] [1] [10]

Regulation by country

Canada

In Canada, there are four drug schedules: [11]

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. [12] The drugs found in each schedule may vary from province to province.[ citation needed ]

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: [13]

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). [14] 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 [15]

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. [16] 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. [17]

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. [18]

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. [19] [20] Many OTC monographs need to be updated but updating or changing an OTC monograph requires the slow and burdensome notice-and-comment rulemaking process. [19] The CARES Act includes OTC monograph reform provisions that replace the rulemaking process with an administrative order process. [19]

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. 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.

Plan B One-Step Plan b one step.jpg
Plan B One-Step

A similar regulation once applied to some forms of emergency contraception. However, on February 25, 2014, the FDA approved generic one-pill emergency contraception products for unrestricted sale on the shelf. There is no age limit or need for ID to purchase. [21]

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. [22] Finally, pharmacies frequently require a prescription for Schedule V drugs as a matter of policy, despite their OTC status according to applicable laws and regulations. [ citation needed ]

United Kingdom

In the United Kingdom, medication is governed by the Medicines Regulations 2012. Medication falls into one of three categories: [1] [23]

  1. 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. Just a small example 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.
  2. 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.
  3. Pharmacy Medicines (P) are medicines that 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. 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. [24]

Transitions 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. [25] 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). [26]

Over time, often 3–6 years, drugs that prove themselves safe and appropriate as prescription medicines may be switched from prescription to OTC.[ citation needed ] An example of this is diphenhydramine (Benadryl), an anti-histamine which once required a prescription but now is available OTC nearly everywhere.[ citation needed ] More recent[ when? ] examples are cimetidine and loratadine in the United States, and ibuprofen in Australia.[ citation needed ]

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. [27] A study has been done examining consumer's perceptions about the risk of and access to nonprescription medication. The study concluded that a small percentage of consumers prefer having access to medication over potential risks of taking non-prescribed medication. [28] Ranitidine was suspended in multiple markets due to concerns over the presence of the carcinogen N-nitrosodimethylamine (NDMA). [29] [30] [31] [32]

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 Manchester, England (previous available as prescription only). Men aged between 30 and 65 could buy four tablets after a consultation with a pharmacist. [33]

See also

Related Research Articles

<span class="mw-page-title-main">Pseudoephedrine</span> Pharmaceutical drug

Pseudoephedrine (PSE) is a sympathomimetic drug of the phenethylamine and amphetamine chemical classes. It may be used as a nasal/sinus decongestant, as a stimulant, or as a wakefulness-promoting agent in higher doses.

<span class="mw-page-title-main">Ibuprofen</span> Medication used for treating pain, fever, and inflammation

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to relieve pain, fever, and inflammation. This includes painful menstrual periods, migraines, and rheumatoid arthritis. It may also be used to close a patent ductus arteriosus in a premature baby. It can be used orally or intravenously. It typically begins working within an hour.

<span class="mw-page-title-main">Ephedrine</span> Medication and stimulant

Ephedrine is a central nervous system (CNS) stimulant that is often used to prevent low blood pressure during anesthesia. It has also been used for asthma, narcolepsy, and obesity but is not the preferred treatment. It is of unclear benefit in nasal congestion. It can be taken by mouth or by injection into a muscle, vein, or just under the skin. Onset with intravenous use is fast, while injection into a muscle can take 20 minutes, and by mouth can take an hour for effect. When given by injection it lasts about an hour and when taken by mouth it can last up to four hours.

<span class="mw-page-title-main">Prescription drug</span> Medication legally requiring a medical prescription before it can be dispensed

A prescription drug is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.

<span class="mw-page-title-main">Loratadine</span> Antihistamine medication

Loratadine, sold under the brand name Claritin among others, is a medication used to treat allergies. This includes allergic rhinitis and hives. It is also available in drug combinations such as loratadine/pseudoephedrine, in which it is combined with pseudoephedrine, a nasal decongestant. It is taken orally.

<span class="mw-page-title-main">Naproxen</span> Nonsteroidal anti-inflammatory drug (NSAID) used to treat pain

Naproxen, sold under the brand name Aleve among others, is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain, menstrual cramps, inflammatory diseases such as rheumatoid arthritis, gout and fever. It is taken orally. It is available in immediate and delayed release formulations. Onset of effects is within an hour and lasts for up to twelve hours.

<span class="mw-page-title-main">Benadryl</span> Brand of various antihistamine medications

Benadryl is a brand of various antihistamine medications used to stop allergies, whose content varies in different countries, but which includes some combination of diphenhydramine, acrivastine, and/or cetirizine.

<span class="mw-page-title-main">Guaifenesin</span> Expectorant medication

Guaifenesin, also known as glyceryl guaiacolate, is an expectorant medication taken by mouth and marketed as an aid to eliminate sputum from the respiratory tract. Chemically, it is an ether of guaiacol and glycerine. It may be used in combination with other medications. A 2014 study found that guaifenesin has no effect on sputum production or clearance in upper respiratory infections.

<span class="mw-page-title-main">Dihydrocodeine</span> Opioid

Dihydrocodeine is a semi-synthetic opioid analgesic prescribed for pain or severe dyspnea, or as an antitussive, either alone or compounded with paracetamol (acetaminophen) or aspirin. It was developed in Germany in 1908 and first marketed in 1911.

<span class="mw-page-title-main">Regulation of therapeutic goods</span> Legal management of drugs and restricted substances

The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.

<span class="mw-page-title-main">Ranitidine</span> Medication that decreases stomach acid

Ranitidine, sold under the brand name Zantac among others, is a medication used to decrease stomach acid production. It is commonly used in treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome. It can be given by mouth, injection into a muscle, or injection into a vein. In September 2019, the probable carcinogen N-nitrosodimethylamine (NDMA) was discovered in ranitidine products from a number of manufacturers, resulting in recalls.

<span class="mw-page-title-main">Olopatadine</span> Chemical compound

Olopatadine, sold under the brand name Patanol among others, is an antihistamine medication used to decrease the symptoms of allergic conjunctivitis and allergic rhinitis. It is used as eye drops or as a nasal spray. The eye drops generally result in an improvement within half an hour.

<span class="mw-page-title-main">Standard for the Uniform Scheduling of Medicines and Poisons</span> Australian legal instrument

The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), also known as the Poisons Standard for short, is an Australian legislative instrument produced by the Therapeutic Goods Administration (TGA). Before 2010, it was known as the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The SUSMP classifies drugs and poisons into different Schedules signifying the degree of control recommended to be exercised over their availability to the public. As of 2023, the most recent version is the Therapeutic Goods Instrument 2023.

Actifed is a registered trademark for a combination antihistamine and nasal decongestant medication used for cold and allergy symptoms. Actifed was developed in 1958 by Burroughs Wellcome & Company, later Haleon.

<span class="mw-page-title-main">Compounding</span> Preparation of a custom medication

In the field of pharmacy, compounding is preparation of custom medications to fit unique needs of patients that cannot be met with mass-produced products. This may be done, for example, to provide medication in a form easier for a given patient to ingest, or to avoid a non-active ingredient a patient is allergic to, or to provide an exact dose that isn't otherwise available. This kind of patient-specific compounding, according to a prescriber's specifications, is referred to as "traditional" compounding. The nature of patient need for such customization can range from absolute necessity to individual optimality to even preference.

<span class="mw-page-title-main">Combat Methamphetamine Epidemic Act of 2005</span> US law

The Combat Methamphetamine Epidemic Act of 2005 (CMEA) is federal legislation enacted in the United States on March 9, 2006, to regulate, among other things, retail over-the-counter sales of following products because of their use in the manufacture of illegal drugs:

<span class="mw-page-title-main">Codeine</span> Opiate and prodrug of morphine used to treat pain

Codeine is an opiate and prodrug of morphine mainly used to treat pain, coughing, and diarrhea. It is also commonly used as a recreational drug. It is found naturally in the sap of the opium poppy, Papaver somniferum. It is typically used to treat mild to moderate degrees of pain. Greater benefit may occur when combined with paracetamol (acetaminophen) or a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin or ibuprofen. Evidence does not support its use for acute cough suppression in children or adults. In Europe, it is not recommended as a cough medicine in those under 12 years of age. It is generally taken by mouth. It typically starts working after half an hour, with maximum effect at two hours. Its effects last for about four to six hours. Codeine exhibits abuse potential similar to other opioid medications, including a risk of habituation and overdose.

Over-the-counter counseling refers to the counseling that a pharmacist may provide on the subject of initiating, modifying, or stopping an over-the-counter (OTC) drug product. OTC counseling requires an assessment of the patient's self-care concerns and drug-related needs. The types of drugs that are involved in OTC counseling are, for example, used to treat self-diagnosable conditions like heartburn, cough, and rashes, though prescription drugs and professional diagnoses are also relevant to the recommendation process.

<span class="mw-page-title-main">Pharmacy (shop)</span> Shop which provides pharmaceutical drugs

A pharmacy is a retail shop which provides pharmaceutical drugs, among other products. At the pharmacy, a pharmacist oversees the fulfillment of medical prescriptions and is available to counsel patients about prescription and over-the-counter drugs or about health problems and wellness issues. A typical pharmacy would be in the commercial area of a community.

<span class="mw-page-title-main">Poison Prevention Packaging Act of 1970</span> US law

The Poison Prevention Packaging Act of 1970 (PPPA); was signed into law by U.S. President Richard Nixon on December 30, 1970. It was enacted by the 91st United States Congress. This law required the use of child-resistant packaging for prescription drugs, over-the-counter (OTC) drugs, household chemicals, and other hazardous materials that could be considered dangerous for children.

References

  1. 1 2 3 4 5 6 Millar A (February 2018). "Defining OTC Drugs". Pharma Technology Focus (67). Retrieved 3 February 2018.
  2. ↑ "Over-the-Counter Medicines: What's Right for You?" U.S. Food and Drug Administration (30 April 2009). Retrieved 4 July 2012.
  3. ↑ "Understanding Over-the-Counter Medicines". Center for Drug Evaluation and Research. U.S. Food and Drug Administration. 14 August 2019. Retrieved 26 August 2019.
  4. ↑ "Prescription Drugs and Over-the-Counter (OTC) Drugs: Questions and Answers". Center for Drug Evaluation and Research. U.S. Food and Drug Administration. 25 April 2019.
  5. ↑ Saha A, Balakrishnan S, Trivedi N, Abraham GM (1 January 2023). "Hypertension and Severe Hypokalemia Associated With Oral Ingestion of Topical Hydrocortisone Cream". AACE Clinical Case Reports. 9 (1): 2–4. doi:10.1016/j.aace.2022.10.004. PMC   9837079 . PMID   36654996.
  6. ↑ Sánchez-Sánchez E, Fernández-Cerezo FL, Díaz-Jimenez J, Rosety-Rodriguez M, Díaz AJ, Ordonez FJ, et al. (May 2021). "Consumption of over-the-Counter Drugs: Prevalence and Type of Drugs". International Journal of Environmental Research and Public Health. 18 (11): 5530. doi: 10.3390/ijerph18115530 . PMC   8196755 . PMID   34064096.
  7. ↑ Qato DM, Wilder J, Schumm LP, Gillet V, Alexander GC (April 2016). "Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011". JAMA Internal Medicine. 176 (4): 473–482. doi:10.1001/jamainternmed.2015.8581. PMC   5024734 . PMID   26998708.
  8. ↑ Esher A, Coutinho T (August 2017). "Rational use of medicines, pharmaceuticalization and uses of methylphenidate". Ciencia & Saude Coletiva (in Portuguese). 22 (8): 2571–2580. doi: 10.1590/1413-81232017228.08622017 . PMID   28793073.
  9. ↑ Sánchez-Sánchez E, Fernández-Cerezo FL, Díaz-Jimenez J, Rosety-Rodriguez M, Díaz AJ, Ordonez FJ, et al. (May 2021). "Consumption of over-the-Counter Drugs: Prevalence and Type of Drugs". International Journal of Environmental Research and Public Health. 18 (11): 5530. doi: 10.3390/ijerph18115530 . PMC   8196755 . PMID   34064096.
  10. ↑ Saha A, Balakrishnan S, Trivedi N, Abraham GM (1 January 2023). "Hypertension and Severe Hypokalemia Associated With Oral Ingestion of Topical Hydrocortisone Cream". AACE Clinical Case Reports. 9 (1): 2–4. doi:10.1016/j.aace.2022.10.004. PMC   9837079 . PMID   36654996.
  11. ↑ "NDS Process and Scheduling Factors". National Association of Pharmacy Regulatory Authorities. Retrieved 26 August 2019.
  12. ↑ "Drug Scheduling in Canada". National Association of Pharmacy Regulatory Authorities. Retrieved 26 August 2019.
  13. ↑ Geneesmiddelenwet
  14. ↑ Drug Development and Review Definitions. Fda.gov (2015-08-20). Retrieved on 2019-08-26.
  15. ↑ Drug Applications for Over-the-Counter (OTC) Drugs. Fda.gov (2015-01-07). Retrieved on 2019-08-26.
  16. ↑ "Drug Applications for Over-the-Counter (OTC) Drugs". Center for Drug Evaluation and Research. U.S. Food and Drug Administration. 29 May 2019. Retrieved 26 August 2019.
  17. ↑ Regulation of Nonprescription Drug Products Fda.gov. Retrieved on 2014-04-24.
  18. ↑ OTC Drug Facts Label. Fda.gov (2015-06-05). Retrieved on 2019-08-26.
  19. 1 2 3 "An Exciting New Chapter in OTC Drug History: OTC Monograph Reform". U.S. Food and Drug Administration (FDA). 6 August 2020. Retrieved 2 September 2020.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  20. ↑ Over-the-Counter Monograph User Fee Program Performance Goals and Procedures - Fiscal Years 2018-2022 (PDF) (Report). U.S. Food and Drug Administration (FDA). Retrieved 2 September 2020.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  21. ↑ "Princeton University". Archived from the original on 19 April 2021. Retrieved 4 February 2020.
  22. ↑ Controlled Substances Listed in Schedules III, IV, and V Archived 2021-03-21 at the Wayback Machine . US Department of Justice - Drug Enforcement Administration. Retrieved on 2019-08-26.
  23. ↑ "Medicines information". NHS Choices. Retrieved 19 September 2017.
  24. ↑ "Availability of medicines". Archived 2010-03-29 at the Wayback Machine . MHRA. Retrieved on 2012-07-04.
  25. ↑ Sánchez-Sánchez E, Fernández-Cerezo FL, Díaz-Jimenez J, Rosety-Rodriguez M, Díaz AJ, Ordonez FJ, et al. (May 2021). "Consumption of over-the-Counter Drugs: Prevalence and Type of Drugs". International Journal of Environmental Research and Public Health. 18 (11): 5530. doi: 10.3390/ijerph18115530 . PMC   8196755 . PMID   34064096.
  26. ↑ Sánchez-Sánchez E, Fernández-Cerezo FL, Díaz-Jimenez J, Rosety-Rodriguez M, Díaz AJ, Ordonez FJ, et al. (May 2021). "Consumption of over-the-Counter Drugs: Prevalence and Type of Drugs". International Journal of Environmental Research and Public Health. 18 (11): 5530. doi: 10.3390/ijerph18115530 . PMC   8196755 . PMID   34064096.
  27. ↑ "Phenylpropanolamine (PPA) Information Page". Center for Drug Evaluation and Research. U.S. Food and Drug Administration. 22 December 2005.
  28. ↑ Alexander GC, Mohajir N, Meltzer DO (2005). "Consumers' perceptions about risk of and access to nonprescription medications". Journal of the American Pharmacists Association. 45 (3): 363–370. doi:10.1331/1544345054003868. PMID   15991758.
  29. ↑ "Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)". U.S. Food and Drug Administration . 11 October 2019. Archived from the original on 24 October 2019. Retrieved 23 October 2019.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  30. ↑ "FDA Requests Removal of All Ranitidine Products (Zantac) from the Market". U.S. Food and Drug Administration (FDA) (Press release). 1 April 2020. Retrieved 1 April 2020.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  31. ↑ "Suspension of ranitidine medicines in the EU". European Medicines Agency (EMA) (Press release). 30 April 2020. Retrieved 2 June 2020.
  32. ↑ "Ranitidine". Therapeutic Goods Administration (TGA). 2 April 2020. Archived from the original on 29 August 2021. Retrieved 19 July 2020.
  33. ↑ "Over-the-counter Viagra piloted". BBC News Online. 11 February 2007. Retrieved 10 February 2009.
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