Over-The-Counter Drugs Laws

Issues of Concern

Federal Food, Drug, and Cosmetic Act (1938)

This act comprises 10 chapters defining food, food additives, chewing gum, drugs, dietary supplements, and medical devices and outlines their production, marketing, and distribution safety standards. This act applies to prescription and OTC medications, cosmetic products, and tobacco products. This act replaced the Pure Food and Drug Act (1906) and was created after more than 100 deaths due to a toxic solvent (diethylene glycol) used in the liquid formation of sulfanilamide. Before the Federal Food, Drug, and Cosmetic Act, pharmaceutical companies were not required to provide evidence of medication effectiveness or safety before selling them to the general public.[2][3]

Durham-Humphrey Amendment (1951)

This amendment to the FFDCA defines medications into 2 distinct categories: legend (prescription) and over-the-counter. Before this amendment, there was no requirement that a medication be available by prescription only. Additionally, this law requires legend medications to contain a label that states, "Caution: Federal Law prohibits dispensing without a prescription." This amendment targets medications that are habit-forming or addictive, as well as medications that may be harmful to the patient, only to be used under the supervision of a doctor or other licensed healthcare provider.[4] Some medications are available by prescription or OTC. These drugs have received legend and over-the-counter approval by the FDA. Often, the difference between a legend drug and its OTC counterpart may be dose strength, such as ibuprofen, where the prescription strength can be 4 times the OTC dose strength. 

Kefauver-Harris Amendment (1962)

This amendment to the FFDCA was passed in response to the thalidomide tragedy in the late 1950s in the UK and West Germany, where thalidomide was available OTC. Thalidomide is a sedative that was also found to be an effective anti-emetic and was particularly effective at treating morning sickness associated with pregnancy. Hundreds of infants were born with birth defects after their mothers had taken the medication for morning sickness despite a lack of testing for safety in pregnancy, which was not unusual at the time.

The amendment requires pharmaceutical companies to provide scientific evidence of the safety and efficacy of medications. The medications must be proven safe for general consumer consumption and be proven to be more effective than placebo or previously existing therapies to treat a condition. This amendment was key to establishing phased clinical trials, now considered routine for new medications.[5][6][7] In addition to safety and therapeutic effectiveness, this amendment requires that advertising and labeling for the drugs include information regarding the side effects of the medication. This law also mandated that the common names, or generic, for the active ingredient(s) be included on the label.

Compliance Policy Guide (CPG) Sec. 450.500 Tamper Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products (1982)

This policy is part of the Good Manufacturing Practices (GMP), which is enforced by the FDA. This requires all OTC drugs to be packaged with an indicator or barrier to entry. The packaging must also contain labeling that states what the tamper-resistant features are to notify the consumer so that they can easily determine if the OTC drug has been tampered with on visual inspection. This policy further states that certain types of these OTCs (for example, 2-piece, hard gelatin capsule medications) require a minimum of 2 types of tamper-resistant packing to be used.[FDA. OTC Packaging]

OTC Drug Facts Label regulation of the Federal Register (1999)

This legislation was to simplify labeling on OTC drugs to make the information more user-friendly for the general public. The new labeling was designed after the nutrition facts label found on food. The labels should contain simple language that is easy to read and understand, making it easier for consumers, particularly older adults, to compare OTC medications. The labeling must include the following information: active ingredients, the dosage of active ingredients, uses for the medication, warnings and when to consult a doctor or pharmacist, side effects, dosing instructions on taking the medication, and the inactive ingredients found in the product. In addition to containing all those categories, they must appear in that order, making it easier to compare similar products.[FDA. OTC Label]

The Combat Methamphetamine Epidemic Act (Title VII of the Patriot Act) (2005)

This law placed strict regulations on the storage and sale of OTC medications that are used in the production of the illegal street drug methamphetamine. The law applies to any OTC medications that contain ephedrine, pseudoephedrine, or phenylpropanolamine, which can be used as precursors for methamphetamine. Phenylpropanolamine is no longer available in the United States as an OTC or legend medication. This law requires medications to be kept behind the counter, although they can still be purchased without a prescription. Additionally, the law also limits the amount any one consumer may buy at one time, no more than 3.6 g.

In addition, the act requires ID verification and a log book documenting the transaction, including the date and time of purchase, the amount purchased, and the buyer's name and address. The law also stipulates that the logbook does not have to be completed if the packaged product contains less than 60 mg of pseudoephedrine. Ideally, the logs would be electronic and communicated between pharmacies and states to discourage “pharmacy hopping”.[8][9] The logbooks are to be maintained for 2 years from purchase. The law also states that no person may purchase more than 9 g of the OTC base in person or 7.5 g by mail order over a 30-day timeframe. This also restricts mail-in pharmacies from distributing more than 7.5 g to a patient in 30 days.[USDOJ. CMEA]

Food and Drug Administration Safety and Innovation Act (2012)

This act made the Best Pharmaceutical for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) permanent, however, they do not apply to all legend drugs. The BPCA and the PREA were established to ensure companies consider the pediatric population when seeking approval for new medications. In 1997, the Food and Drug Administration Modernization Act (FDAMA) introduced a voluntary incentive program to encourage pediatric studies when testing medications for safety and efficacy. The incentive included an additional 6 months for the medication's patent for market exclusivity. When companies were not taking advantage of the voluntary incentive, possibly due to the added cost of additional studies, it was replaced by the Pediatric Rule in 1998. The Pediatric Rule made pediatric studies mandatory for any drug product likely to be used in children, even if the company was not seeking approval for pediatric use.

In 2002, a Federal Court ruled that the Pediatric Rule was invalid. Following this ruling in 2002, the FDAMA was reintroduced as the Best Pharmaceutical for Children Act, which was signed into law in 2002. In addition to the patent extension, companies were granted government funding to complete the pediatric studies.[NIH. BPCA] In 2003, the Pediatric Research Equity Act, which contained components of the Pediatric Rule, was introduced. The PREA allows the FDA to require pediatric studies to determine safety and efficacy in children, appropriate dosing, and special formulations (ie, liquid) for children. In addition, a company producing a medication without pediatric testing must submit a waiver to the FDA explaining why the testing can not reasonably or safely be accomplished. While the BPCA and the PREA were reauthorized, they needed to be renewed every 5 years. In 2012, when the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, Title V section 507 permanently reauthorized the BPCA and PREA without requiring a 5-year renewal (FDA. FDASIA).

Federal Trade Commission Act Sections 5 and 12

These laws refer to the advertising for OTC homeopathic medications. They limit the claims companies can put on packaging and state that they must be backed with scientific proof. The Federal Food, Drug, and Cosmetic Act sections 201(g) and 201(j) define homeopathic preparations as medications, as they are listed in the Homeopathic Pharmacopeia, which is recognized as an official drug compendium.[FDA. FFDCA] The Federal Trade Commission Act states that these medications should be treated the same as other health products and OTCs, and all claims of effectiveness should be evidence-based.[FTC. Homeopathic OTCs]

Data have shown that physicians overestimate the regulations in place for medication safety and efficacy. They also believe there needs to be greater emphasis and further regulation on post-market regulation for medications that are ineffective in practice.[10]

With healthcare costs rising, one concern is that the increased regulations, such as the clinical trials established with the Kefauver-Harris Amendment, drive up the cost of OTCs. Establishing safety and efficacy through trials meeting these standards costs millions of dollars, which is then passed on to the consumer. Requiring pharmaceutical companies to prove significant comparative effectiveness over placebo and previously existing treatments leads to a shift towards placebo-controlled randomized trials, which are expensive to produce. In addition to monetary cost, these clinical trials and meeting federal regulations take time, which delays medications being introduced to the market, this is referred to as "drug lag".[11][6] While the FDA has accelerated pathways for approval for legend drugs or events involving public health or safety, such as bioterrorism, it is still responsible for ensuring that these medications, both legend and OTC, are safe and effective.

Clinical Significance

Before these laws were introduced, multiple harmful products entered the market, leading to bodily harm and death. Previously, under the Pure Food and Drug Act, medications only needed a list of active ingredients to be marketed. Consumers and providers were misled by claims made about medications. The FFDCA and its subsequent amendments overhauled the healthcare system, specifically the treatments available. When the Kefauver-Harris amendment was passed, it also led to a retrospective review of medications that had been introduced to the market from the time the Federal Food, Drug, and Cosmetic Act was signed through when the amendment was signed into law. The Drug Efficacy Study Implementation (DESI) evaluated thousands of existing medications for proof of effectiveness for the indications the medication had been labeled to treat. Hundreds of drugs that did not meet these new standards of therapeutic effectiveness were removed from the market then.[5]

OTC medications rely on the ability of a person with no medical training to identify their conditions or symptoms and purchase the medication to treat themselves without the aid of a healthcare provider. These individuals also need to be able to dose the medication safely. This is of particular concern regarding specialized populations such as children, pregnant women, and older adults. While OTCs are generally considered safe, not all medications are safe for all ages and populations. There is also concern about appropriate weight-based dosing with children.[12][13][14][15][14][16]

Nursing, Allied Health, and Interprofessional Team Interventions

These laws require a multidisciplinary team approach involving pharmacists, pharmacy technicians, physicians, nurses, and other healthcare professionals to ensure patients are safely and effectively getting the treatments they need. Ensuring that nursing staff performing intake are inquiring about OTCs and dietary supplements, and physicians and other licensed practitioners advise patients about OTCs they should avoid. Pharmacists are also able to advise patients about safety, drug interactions, and dosing. This becomes particularly important when dealing with special patient populations, such as older adults, children, or pregnant women.[16][17]