Pharmacy Laws

Pure Food and Drug Act of 1906

Concerns for public health risk due to unsanitary and poorly labeled products

Prohibits adulteration of misbranding food and drugs

in 1912, was amended to prohibit false claims

difficult to enforce, failed to achieve it’s purpose

Food, Drug, and Cosmetic act of 1938 (FDCA)

Helps forms today’s law

Made it so no new drug will be marketed unless proven safe under the label conditions and approved by the FDA

Labels must contain adequate directions for use and warnings

Durham-Humphrey Amendment of 1951

Enacted to help solve the problem from the 1938 FDCA problem of marketed drugs being safe only under medical supoervision

This amendment made it so there were porescription vs OTC drugs

Needed labels to contain the Rx legend if a prescription drug

If dispended by a pharmacist, the directions satisfies the “adequare directions for use” requirement

Authorizes oral prescriptions and refills

Food Additives Amendment of 1958

Amended the FDCA to require components added to food must recieve premarket approval for safety

The Delaney Clause - ANticancer provision

What is the Delaney Clause of The Food Additives Amendment of 1958?

An anticancer provicion, prohibits approval of food additives that can cause cancer

The Color Additive Amendments of 1960

Manufactors are required to establish the safety of color additives in foodsm drugs,m and cosmetics

Kefauver-Harris Amendment of 1962

Strengthened the drug approval process by requiring drugs to be proved safe AND effective

Efficacy requirement was retrioactive to drugs 1938-1962

Transferred jurisdiction of drug advertisting to the FDA

Established the Good Manufacturing Practices (GMP) requirements

added more extensive controls for clinical investigations (informed consent and adverse drugs reactions)

Medical Device Amendment of 1976

Amended the FDCA in 1976 to provide more regulationm to administrative authority to the safety and efficacy of medical devices

classifies the functions of devices, premarket approval, preformance standards, adherence to record and reporting requirements

Orphan Drug Act of 1983

Passed legislation to provide tax and exclusive licensing incentives for manufactures to develop and market drugs for rare diseases or conditions

Drug Price Competition and Patent Term Restoration Act of 1984

Waxman-Hatch Amendment

Helped streamline generic approval process while giving extensions, in certain circumstances, to innovator drugs

Intent is to make generics more available to the public

Prescription Drug Marketing Act of 1987

Establishes sales restrictions and record keeping requirements

Prohibits hospitals and other entities from reselling their pharmaceuticals to other businesses

Requires licensing of drug wholesalers

Safe Medical Devices Act of 1990

Strengthened the Medical Device Amendment by giving the FDA authority related to post marketing requirements and premarket notification and approval, espedites the approval process

The Generic Drug Enforcement Act of 1992

Occured because some FDA staff were taking bribes from the generic drug industry

Bans individuals or firms from participating in the drug approval process if convicted of related felonies

Imposes severe civil penalties

Prescription Drug User Fee Act of 1992

Requires manufactores to pay fees for applications and supplements when the FDA must review clinical studies

Fees provide the FDA with recources to hire reviewers to help speed the process of clinical study reviews and NDA reviews

Nutrition Labeling and Education Act of 1990 (NLEA)

Mandates nutrition labeling on food products and authorizes health claims on labeling

assures they’re in compliance with FDA regulations

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Defines dietary supplements anf permit manufacturers to make certain claims that would be illegal under the FDCA

FDA regualtes dietary supplements like food rather than drugs

Food and Drug Administration Modernization Act of 1997 (FDAMA)

FDAMA was passed to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices

Medical Device User Fee and Modernization Act of 2002

Establishes user fee requirement for premarket reviews of medical devices and established performance goals of premarket reviews

inspections can be conducted to ensure regulatory requirements for devices

renewed by Congress every 5 years

Food and Drug Administration Amendments Act of 2007 (FDAAA)

Provides FDA with more responsibilities and authority to drug safety, label changes, clinical trial data reporting, more strict postmarket clinical studies, and more requirements to risk evaluations (REMS)

FDA Safety and Innovation Act of 2012

Allows FDA to collect fees from manufacturers seeking NDA’s or medical device approvals

Adds the Generic Drug User Fee Act and Biosimilar User Fee Act

The purpose is to increase resources fo the FDA

Adds provisions directed at reducing drug counterfeiting, blocking adulterated products, and allows the FDA to inspect foreign drug manufacturers more regularly

Drug Quality and Security Act of 2013

Title 1: Compounding Quality Act, strengthens and clarifies FDA oversight over pharmacies that do large scale compounding and shipment of sterile products

Title 2: Drug supply Chain Security Act, adds “track and trace” requirements for all entities in the chain of distribution of pharmaceutical products. Also mandates an electronic product tracing system in 2023

The 21st Century Cures Act of 2016

Helps to streamline and add flexibility and innovation to the drug development and approval process. creates a new clinical trial design option and accelerates the pathway to market drugs for certain serious diseases

Helps provides billions in funding to the National Institute of Health, NIH

FDA Reauthorization Act of 2017

Reauthorized the user fee programs and enhanced goals of the Cures Act

Created a new category of OTC hearing aids