Eleven physicians meet in Washington, D.C., to establish the U.S. Pharmacopeia, the first compendium of standard drugs for the United States.
First federal drug law, passed in response to soldier deaths from what was believed to be adulterated quinine. Required inspections of all medication entering the US.
Charles M. Wetherill, chemist, is appointed to serve in the new Department of Agriculture. This was the beginning of the Bureau of Chemistry, the predecessor of the Food and Drug Administration.
First drug law of 20th century. Required federal government to issue approval for biological drugs. Prompted by deaths of children from diptheria and small pox vaccines.
The original Food and Drugs Act is passed by Congress on June 30 and signed by President Theodore Roosevelt. It prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs. The Meat Inspection Act is passed the same day. Shocking disclosures of insanitary conditions in meat-packing plants, the use of poisonous preservatives and dyes in foods, and cure-all claims for worthless and dangerous patent medicines were the major problems leading to the enactment of these laws.
Drug label indicated it could cure cancer, however court held that the 1906 act covered only misbranding of contents not therapeutics.
Attempt by Congress to close loophole in 1906 act that allowed false therapeutic claims. Misbranding indications now a violation if government could prove claims were false and that there was attempt to defraud.
Prior to this act, opiates were legally dispensed with a prescription. This act made prescribing for the purpose of supporting addiction a crime.
This act aimed to protect children from accidental poisoning by requiring warning labels and antidotes be placed on about a dozen household substances
SE Massengill Co marketed sulfanilamide elixir, in diethylene glycol vehicle, that killed 107 people.
Prompted by the sulfanilamide deaths, this act required new drugs to have demonstrated safety, eliminated the Sherley Amendment requirement of proving intent to defraud, authorized inspections and court injunctions.
Requires FDA to test and certify purity and potency of this lifesaving drug for diabetes.
Quaker Oats farina "enriched with vitamin D" did not meet FDA definition of "enriched." This was held to be possibly confusing to the consumer regardless of whether the added ingredient was wholesome or not.
Supreme Court held Dotterweich, president of Buffalo Pharmacal, responsible for adulteration and misbranding of drugs even without intent or knowledge.
Included regulation of biological products and control of communicable diseases.
Required FDA testing and certification of safety and effectiveness of all penicillin products. Later amendments extended this requirement to all antibiotics. In 1983 such control was found no longer needed and was abolished.
Court of appeals rules that the directions for use on a drug label must include the purpose for which the drug is offered. Therefore, a worthless remedy cannot escape the law by not stating the condition it is supposed to treat.
Defines the kinds of drugs that cannot be safely used without medical supervision and restricts their sale to prescription by a licensed practitioner.
Requires prominent label warnings on hazardous household chemical products.
Thalidomide is found to have caused birth defects in thousands of babies born in western Europe. News reports on the role of Dr. Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market, arouse public support for stronger drug regulation.
In response to the thalidomide tragedy, for the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them.
Enacted to deal with problems caused by abuse of depressants, stimulants and hallucinogens. Restricted research into psychoactive drugs such as LSD by requiring FDA approval. Required symbols on drugs of abuse containers (CII, CIII, etc.) and increased record keeping requirements.
The FDA contracts with the National Academy of Sciences to evaluate effectiveness of 4,000 drugs that were approved on safety alone.
Bureau of Narcotics and Dangerous Drugs is transferred from FDA to Justice Department. This was renamed the Drug Enforcement Administration in 1970.
Formed to implement recommendations of the National Academy of Science investigations.
Evidence of drug safety and efficacy not supported by commercial success.
This law brings together a number of laws regulating the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances.
Special packaging requirements to protect children from accidental poisonings.
OTC drug review begun to examine the safety, effectiveness and appropriate labeling of non-prescription products.
Gave FDA regulatory authority over prescription devices.
FDA anti-tampering regulations require that "cosmetic liquid oral hygiene products" and vaginal products, contact lens solutions, and most over-the-counter drugs to be packaged in tamper-resistant packages.
Passed to promote research and marketing of drugs needed for treating rare diseases.
Abbreviated NDAs for generic versions of brand-name drugs are deemed acceptable. Companies can apply for up to five years patent extension to make up for approval time.
Bans sale or trade of drug samples. Wholesalers required to be licensed.
Identifies anabolic steroids as a class of drugs and specifies over two dozen items as controlled substances. In addition, a four-part definition of this class is established to permit new, black market compounds to be assigned to this category, and thus subject to regulation as controlled substances.
Regulations published to Accelerate the Review of Drugs for life-threatening diseases.
Imposes debarment and other penalties for illegal acts involving abbreviated drug applications.
Requires drug and biologics manufacturers to pay fees for product applications and supplements, and other services. The act also requires FDA to use these funds to hire more reviewers to assess applications.
Pharmacist have duty to perform prospective drug utilization reviews and maintain patient records.
A consolidation of several adverse reaction reporting systems is launched as MedWatch, designed for voluntary reporting of problems associated with medical products to be filed with FDA by health professionals. Revising a policy from 1977 that excluded women of childbearing potential from early drug studies, FDA issues guidelines calling for improved assessments of medication responses as a function of gender. Companies are encouraged to include patients of both sexes in their investigations of drugs and to analyze any gender-specific phenomena.
Establishes specific labeling requirements, provides a regulatory framework, and authorizes FDA to promulgate good manufacturing practice regulations for dietary supplements. This act defines "dietary supplements" and "dietary ingredients" and classifies them as food. The act also establishes a commission to recommend how to regulate claims.
Reauthorizes the Prescription Drug User Fee Act of 1992 and mandates the most wide-ranging reforms in agency practices since 1938. Provisions include measures to accelerate review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods.
Improves safety and efficacy of patented and off-patent medicines for children. It continues the exclusivity provisions for pediatric drugs as mandated under the Food and Drug Administration Modernization Act of 1997, in which market exclusivity of a drug is extended by six months, and in exchange the manufacturer carries out studies of the effects of drugs when taken by children. The provisions both clarify aspects of the exclusivity period and amend procedures for generic drug approval in cases when pediatric guidelines are added to the labeling.
Prescription drug coverage added to Medicare.
A ban on over-the-counter steroid precursors, increased penalties for making, selling, or possessing illegal steroids precursors, and funds for preventive education to children
Deeming such products to present an unreasonable risk of harm, FDA bans dietary supplements containing ephedrine alkaloids based on an increasing number of adverse events linked to these products and the known pharmacology of these alkaloids.
Provides rules for handling of protected health information and applies to every pharmacy.
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