Prescription Laws: When Did They Start?

The prescription became law in the United States with the Food, Drug, and Cosmetic Act (FDCA) of 1938, which expanded the role of the Federal Food and Drug Administration (FDA) in regulating all medications in the country. This law defined two main classes of medications: over-the-counter (OTC) and prescription medications. Prescription medications are drugs that require a prescription and specific labelling and directions to be deemed safe. They are considered habit-forming, toxic, or carry a potential for harm. The FDCA was further amended by the Durham-Humphrey Amendment of 1951, which established guidelines for pharmacists dispensing prescription medications. The FDA also oversees the approval process for new drugs, ensuring their safety and efficacy before they enter the market.

The Federal Food and Drug Administration (FDA)

The FDA is charged with protecting the health of the US public by ensuring the quality of its food, medicine, and cosmetics. The agency has the power to impose any restrictions on medications that are deemed unsafe for public consumption. The FDA also has the authority to issue and enforce quality standards for food, drugs, medical devices, and cosmetics, as well as inspect facilities where these products are manufactured, processed, packaged, and stored.

The FDA's regulatory powers were expanded with the passing of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938, which was signed into law by President Franklin Delano Roosevelt on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labelling. The law also authorized factory inspections, set new regulatory standards for foods, and brought cosmetics and therapeutic devices under federal regulatory authority.

The FD&C Act also securely codified the category of "prescription-only" drugs into law. The Durham-Humphrey Amendment, which came into effect after the passing of the FD&C Act, defines the types of medications that cannot be safely used without medical supervision and mandates that certain drugs be made available by prescription only. The Amendment requires these prescription medications to be dispensed with a valid prescription by a practitioner who is licensed by law to prescribe them.

Prescription Drug Marketing Act (PDMA)

The Prescription Drug Marketing Act (PDMA) of 1987 is a law enacted by the United States federal government to establish a legal framework for the safe and effective distribution of prescription drugs. It was signed into law by the President on April 22, 1988, with the primary goal of ensuring that drug products purchased by consumers are safe and effective. The legislation aimed to increase safeguards in the drug distribution system, preventing the sale of compromised, expired, and counterfeit drugs within an unregulated wholesale market.

The PDMA was enacted to address the growing presence of wholesale markets outside of legal distribution channels, known as the "diversion market." This market facilitated the sale of counterfeit, adulterated, misbranded, subpotent, or expired drugs, posing an unacceptable risk to American consumers. The law establishes that prescription drugs manufactured in the US and exported abroad are not eligible for reimportation unless deemed by the manufacturer. It also restricts the sale of drug samples to licensed providers and specified distribution channels.

The PDMA encourages wholesale distributors to become authorized distributors of record (ADR) by entering into written agreements that authorise them to sell particular drugs. It outlines steps for hospitals to return prescription drugs to the manufacturer/wholesaler, provided they document the drugs' receipt, return, or destruction. The law also addresses concerns about drug affordability and the presence of loopholes that seek to circumvent its regulations.

The clinical significance of the PDMA is highlighted by the fact that over 45% of Americans take at least one prescription medication. The law ensures that prescription drugs available to the US population are safe and effective, with the Food and Drug Administration (FDA) monitoring the integrity of raw materials used in their manufacturing. The FDA's role in regulating prescription drugs has evolved, with new laws addressing challenges in healthcare delivery and efforts to circumvent its regulations.

In summary, the Prescription Drug Marketing Act (PDMA) of 1987 is a critical piece of legislation in the United States, ensuring the safety and effectiveness of prescription drugs through increased regulation and safeguards in their distribution.

Controlled Substances Act (CSA)

The Controlled Substances Act (CSA) is a federal US law that regulates the manufacture, distribution, importation, possession, and use of certain substances. Passed by the 91st US Congress in 1970 and signed into law by President Richard Nixon, the CSA establishes a federal policy to regulate controlled substances and creates a legal framework for their regulation.

The CSA places all substances under the control of existing federal law into one of five schedules. These schedules are based on the substance's medical use, potential for abuse, and safety or dependence liability. The higher the schedule number, the lower the potential for abuse and the lower the risk of addiction and harm. Schedule I drugs have the highest potential for abuse and no accepted medical use, while Schedule V drugs have the lowest potential for abuse and are considered to have accepted medical uses.

The CSA outlines the requirements for prescribing, dispensing, storing, and disposing of controlled substances. It also establishes a closed system of distribution, requiring all individuals and firms authorised to handle controlled substances to maintain complete and accurate inventories and records of all transactions.

The CSA has been amended numerous times since its enactment, including the 2010 Secure and Responsible Drug Disposal Act, which allowed pharmacies to create take-back programs for controlled medications, and the 2017 Protecting Patient Access to Emergency Medications Act, which included registration for emergency medical services to administer controlled substances.

Poison Prevention and Packaging Act (PPPA)

The Poison Prevention and Packaging Act (PPPA) was signed into law by US President Richard Nixon on December 30, 1970. The Act was established to protect children under the age of five from accidental poisoning by requiring certain substances to be in child-resistant packaging. This included prescription drugs, over-the-counter (OTC) drugs, household chemicals, and other hazardous materials that could be dangerous for children.

The PPPA defines "household substances" as any substance customarily produced, distributed for sale or consumption, or stored by individuals in or around the household, which falls into one of the following categories:

• A hazardous substance as defined in the Federal Hazardous Substances Act (FHSA).
• A food, drug, or cosmetic as defined in the Federal Food, Drug, and Cosmetic Act.
• A substance intended for use as fuel when stored in a portable container and used in a heating, cooking, or refrigeration system of a house.

The PPPA allows for exemptions from child-resistant packaging for the elderly and people with disabilities who may have difficulty opening such containers. In these cases, manufacturers can package over-the-counter household substances in a single non-complying size, provided there is a warning that it is not recommended for households with children, and the product is also supplied in complying popular-size packages. Additionally, prescription drugs may be dispensed in non-child-resistant packaging upon the request of the prescribing doctor or the patient.

The Consumer Products Safety Commission (CPSC) monitors compliance with the PPPA, while the FDA provides guidance. Since its implementation, the PPPA has led to a significant decrease in child injuries, with an 80% decline in poisoning fatalities among children under five between 1972 and 2020.

Combat Methamphetamine Epidemic Act (CMEA)

The Combat Methamphetamine Epidemic Act (CMEA) was established in 2005 to regulate the retail over-the-counter (OTC) sales of certain products commonly used in the manufacture of illegal drugs, such as methamphetamine. The CMEA was signed into law by the President on March 9, 2006, as Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005.

The CMEA targets specific precursor chemicals, including ephedrine, pseudoephedrine, and phenylpropanolamine, which are often found in cough, cold, and allergy products. These chemicals can be used to produce illicit drugs like methamphetamine or amphetamine. The legislation aimed to curb the clandestine production of methamphetamine by imposing strict regulations on the sale and distribution of these precursor chemicals.

The CMEA implemented several key measures to achieve its goals. It created a master list of "scheduled listed chemical products" (SLCP) under the Food, Drug, and Cosmetic Act, which included any product containing ephedrine or pseudoephedrine. The act also established stringent requirements for record-keeping, reporting lost or stolen items, and proof of identity upon purchase. Sellers were mandated to document each sale, recording the purchaser's name, the amount sold, and the date and time of the transaction. These records had to be maintained for a minimum of two years, and sellers were responsible for reporting any theft or loss of items containing the regulated chemicals to the Drug Enforcement Administration (DEA) within 15 days.

Additionally, the CMEA mandated that sellers verify the identity of all purchasers by requiring a valid picture ID. This information was then entered into a database to monitor for "pharmacy shopping" activity, where individuals visit multiple pharmacies to obtain quantities of ephedrine-containing products beyond legal limits. The act also imposed daily and monthly purchase limits on these regulated products, with a limit of 3.6 grams of pseudoephedrine base per day and 9 grams per month.

The CMEA also addressed the training and self-certification of sellers. It required sellers to undergo training to ensure compliance with the act's provisions and to self-certify their adherence to the regulations. This included training employees on the requirements of the CMEA, maintaining retrievable records of all purchases, verifying proof of identity, and reporting suspicious transactions to law enforcement.

Overall, the CMEA established comprehensive measures to combat the illicit production and sale of methamphetamine by regulating the sale and distribution of key precursor chemicals. These regulations aimed to reduce the availability of these chemicals for illegal purposes while still allowing legitimate access for medical needs.

Frequently asked questions