Edict of Frederick II
Old European edict that separated the profession of pharmacy from the profession of medicine.
Drug Importation Act of 1848
This act required imported drugs to meet the standards for strength and purity established in the USP
Model Law 1900
This law define the difference between a pharmacist and a mere merchant.
Federal Pure Food and Drug Act of 1906
This act established that drugs (as well as foods) could be considered interstate commerce (between states).
Federal Pure Food and Drug Act of 1906
This act established penalties for misbranding and adulteration
Federal Pure Food and Drug Act of 1906
This act made the USP and NF the official standards of "adulteration" of a drug
Federal Pure Food and Drug Act of 1906
This act was amended to prohibit false and fraudulent efficacy claims
Food, Drug, and Cosmetic Act of 1938
The deaths associated with elixir sulfanilamide in 1937 led to the establishment of this act
Food, Drug, and Cosmetic Act of 1938
This act required that no new drug could be marketed until it was proven safe to be used under the conditions described on the label and approved by the FDA.
Food, Drug, and Cosmetic Act of 1938
Under this act, drugs marketed prior to 1938 are exempt from being proven safe before marketing.
Food, Drug, and Cosmetic Act of 1938
This act was amended to require batch certification of safety and efficacy of insulin and penicillin in 1945, although these requirements were eliminated in 1997.
Durham Humphrey Amendment 1951
This amendment established two classes of drugs, prescription and over the counter.
Durham Humphrey Amendment 1951
This amendment provided that labels of prescription drugs do not require adequate directions for use, if they contain the legend, "Caution: federal law prohibits dispensing without a prescription.
Durham Humphrey Amendment 1951
This amendment established that if a drug is dispensed by a pharmacist, directions from prescriber on the label satisfies "adequate directions for use requirement.
Durham Humphrey Amendment 1951
This amendment authorizes oral prescriptions and refills of prescription drugs.
Food Additives Amendment 1958
This amendment required that components added to food products receive premarket approval for safety, unless generally regarded as safe (GRAS).
Food Additives Amendment 1958
The Delaney Clause of this amendment prohibited approval of any food additive that might cause cancer
Color Additive Amendments of 1960
This amendment required manufacturers to establish the safety of color additives in food drugs and cosmetics.
Kefauver-Harris Amendment of 1962
This amendment came about after reports of birth defects from the drug thalidomide
Kefauver-Harris Amendment of 1962
The amendment required drugs be proved not only safe but also effective. The effectiveness requirement was retroactive to all drugs marketed between 1938 and 1962.
Kefauver-Harris Amendment of 1962
This amendment required more extensive controls for clinical investigations including; informed consent of research subjects and reporting of adverse drug reactions.
Kefauver-Harris Amendment of 1962
This amendment established Good Manufacturing Practices (GMP) requirements.
Kefauver-Harris Amendment of 1962
This amendment transferred the jurisdiction of Prescription drug advertising to the FDA from the Federal Trade Commission
Medical Device Amendment of 1976
This amendment came about after public safety concerns with the IUD Dalkon Shield and prompted Congress to add regulation, administrative authority, and premarket approval for the safety and efficacy of medical devices.
Orphan Drug Act of 1983
This act provides tax advantages and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of rare diseases or conditions (those affecting fewer than 200,000 Americans).
Drug Price Competition and Patent Term Restoration Act of 1984
This act provided patent extension in some cases to innovator drugs with the intent to make generic drugs more readily available to the public and to provide incentives for manufacturers to develop new drugs
Safe Medical Devices Act of 1990
This act gave the FDA additional authority related to post-marketing requirements and pre-market notification and approval of medical devices, while expediting the pre-market device approval process.
Generic Drug Enforcement Act of 1992
This act authorized the FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies.
Prescription Drug User Fee Act of 1992
This act required private industry to shoulder part of the costs for reviewing new drugs in the FDA and must be reauthorized every 5 years.
Nutrition Labeling and Education Act of 1990
This act requires nutrition labeling on food products and authorizes health claims on product labeling, so long as the claims are made in compliance with FDA regulations.
Dietary Supplement Health and Education Act of 1994
This act defined dietary supplements and permitted manufacturers to make certain claims that otherwise would have been illegal under the FDCA.
Dietary Supplement Health and Education Act of 1994
This act forced the FDA to regulate dietary supplements more as foods than as drugs.
Food and Drug Administration Modernization Act of 1997
This act created a fast-track approval process for drugs intended for serious or life-threatening disease
Food and Drug Administration Amendments Act of 2007
This act allows the FDA broader use of the fees generated from the Prescription Drug User Fee Act, while substantially increasing the fees.
Food and Drug Administration Amendments Act of 2007
This act provides the FDA with significantly enhanced responsibilities and authorization to regulate drug safety, including the authority to mandate labeling changes related to safety, require clinical trial data reporting and registries, require post-mar
FDA Safety and Innovation Act of 2012
This act reauthorized the Prescription Drug User Fee Act.
FDA Safety and Innovation Act of 2012
This act allows the FDA to continue to collect user fees from manufacturers seeking new drug applications or medical device approvals and added new user fees for generic drugs and biosimilars.
FDA Safety and Innovation Act of 2012
Provisions were added to this act to reduce drug counterfeiting, blocking the import of adulterated products, detecting and reducing drug shortages, and enhancing the exchange of prescription drug diversion information across state lines.
Drug Quality and Security Act of 2013
This act clarified FDA oversight over pharmacies engaged in large-scale compounding & shipping of sterile products to other licensed entities
Drug Quality and Security Act of 2013
This act was passed in response to a meningitis outbreak that killed over 60 people & injured hundreds, caused by contaminated drugs compounded by a New England pharmacy.
Drug Quality and Security Act of 2013
This act adds track-and-trace requirements for all entities in the chain of distribution of pharmaceutical products
Drug Quality and Security Act of 2013
This act required that manufacturers provide transaction information to purchasers and in turn must provide transaction information to subsequent purchasers such as wholesalers and pharmacies.
Drug Quality and Security Act of 2013
This act mandates and electronic interoperable product tracing system by 2023.