Pharmacy Laws And Regulations *

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Pure Food and Drug Act of 1906

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was to forbid the interstate distribution or sale of adulterated and misbranded food and drugs. The drug did not have to label but must not contain false information about the strength or purity of the drug.

(This Act was changed in 1938 to the FD&C Act due to the 107 people who died after taking a sulfa drug product that contained diethylene glycol, which is used today as an antifreeze for cars)

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Food, Drug, and Cosmetic Act of 1938

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created the FDA that approves new drugs and requires pharmaceutical manufacturers to file a new drug application with the FDA and all manufacturers to maintain the purity, strength, effectiveness, safety, and packaging of drugs, foods, and cosmetics.

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Durham-Humphrey Amendment of 1951

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Established the difference between legend (prescription) drugs and OTC (over-the-counter or nonprescription) drugs and authorized the acceptance of verbal prescriptions and refilling of prescriptions.

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Kefauver-Harris Amendment of 1962

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This amendment was passed in response to reports of severe birth defects in infants born to mothers who had taken the tranquilizer thalidomide.

This amendment extended the FDA's requirement that drug products, both prescription and nonprescription be shown to be effective and safe.

(Provisions were added to the act concerning factory inspections and clinical studies and the responsibility for regulating prescription drug advertising was shifted from the Federal Trade Commission (FTC) to the FDA)

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Comprehensive Drug Abuse Prevention and
Control Act of 1970 known as the Control Substance Act (CSA)

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This act controls the manufacture, importation, sale, and distribution of drugs that have the potential for addiction and abuse and are monitored closely.

Under this act, drugs are classified with potential for abuse into five types, or schedules.

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Poison Prevention Packaging Act of 1970

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Requires the majority of OTC and prescription drugs be packaged in child-resistant containers.

The Consumer Product Safety Commission enforces this act.

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Occupational Safety and Health Act of 1970 (OSHA)

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Requires all employers to ensure employee safety and health.

OSHA regulates actual workplaces, safety and health, job-related materials, equipment, and machinery.

OSHA requires Material Safety Data Sheet (MSDS) be used to ensure safety with hazardous chemicals.

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Drug Listing Act of 1972

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Under this Act, each new drug is assigned a unique and permanent product code, known as a National Drug Code (NDC) that identifies the manufacturer or distributor, the drug formulation, and the size and type of its packaging.

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Medical Device Amendments of 1976

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This Act classified medical devices into 3 different regulatory classes.

class I and II do not require premarket approval from by the FDA.

class III devices, such as those used for life-sustaining and life-supporting measures requires premarket approval by the FDA.

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Resource Conservation and Recovery Act (RCRA) of 1976 also known as the Solid Waste Disposal Act

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This Act regulates how solid wastes are handled and authorizes environmental agencies for the proper cleanup of contaminated sites.

The act was established to regulate solid waste landfills and to set guidelines for pollution reduction and elimination.

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Drug Regulation Reform Act of 1978

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Enacted to permit a shorter period for the investigation of new drugs.

It was due to the response to public pressure to allow quicker consumer access.

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Orphan Drug Act of 1983

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This act offers federal financial incentives to commercial and nonprofit organizations to develop and market drugs previously unavailable in the United States.

The orphan drug can be used to treat a rare disease that affects fewer than 200,000 people in the United States.

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Drug Price Competition and Patent Term Restoration Act of 1984

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This act encouraged the creation of both generic drugs (those not protected by trademark) and innovative new drugs.

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Prescription Drug Marketing Act of 1987

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This act deals with safety and competition issues that secondary markets raised for drugs and prohibits the re-importations of drug into the United States.

This act also prohibits the sale or trading and distribution of drug samples to person other than those licensed to prescribe them and distribution of samples except by mail or by common carrier.

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Omnibus Budget Reconciliation Act of 1990

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This act requires pharmacists to offer to discuss information about new and refill prescriptions with each patient.

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FDA Safe Medical Devices Act of 1990

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This act increases the FDA's ability to regulate medical devices and products used in medical diagnostic procedures.

In addition, manufacturers must maintain better quality control and tracking of the devices they market.

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Anabolic Steroid Control Act of 1990

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This act increases the CSA's powers to regulate anabolic steroids, hormonal substances that promote muscle growth.

Anabolic steroids are now listed in Schedule III of the CSA. Human growth hormone is also regulated through this act.

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Americans with Disabilities Act (ADA) of 1990

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This act prohibits the discrimination against people with disabilities.

It oversee accommodations and devices for people with disabilities that help them to live as normally as possible.

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Dietary Supplement Health and Education Act (DSHEA) of 1994

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This act amended the FD&C Act to increase regulations on dietary supplements and how they are labeled.

This act controls the display of, recommendation of, and stocking of dietary supplements.

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Health Insurance Portability and Accountability Act (HIPAA) of 1996

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This act was designed to limit administrative costs of health care and privacy issues and preventing fraud.

It also provide security and confidentiality guarantees for each individual patient.

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FDA Modernization Act (FDAMA) of 1997

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This act affected user fees, compounding in the pharmacy safety, and medical device regulation.

It also requires manufacturers to label all prescription drugs with the symbol "Rx".

This act was designed to speed up the drug approval process and to improve FDA regulation of drugs, biologics, foods, and medical devices.

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Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003

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This act was established to help many senior citizens afford new drugs, the MMA also gave employers the ability to offer their employees drug benefits via the drug subsidies it created.

It introduced prescription drug tax breaks and subsidies and offered new Medicare "Advantage" plans with increased choices about care, providers, coverages, and federal reimbursements.

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Combat Methamphetamine Epidemic Act of 2005

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This act was established to stop illegal methamphetamine use, especially as it related to the funding of terrorist activities.

The act also controls other drugs such as crack cocaine when involved in funding terrorism.

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Medical Tamper-Resistant Prescription Act of 2008

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This act requires written prescriptions for Medicaid covered outpatient drugs to be executed on a tamper resistant prescription.

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Centers for Disease Control and Prevention

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This agency provides facilities and services for the investigation, identification, prevention, and control of disease, injury, and disability.

It provides statics and information to health professionals about the treatment of common and rare diseases worldwide.

It primary functions is to issue regulations for infection control.

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Centers for Medicare and Medicaid Services (CMS)

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This agency stive to modernize the health care system by promoting effective and up-to-date health-care coverage. It also promotes quality health care for beneficiaries.

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Drug Enforcement Agency (DEA)

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This agency enforces controlled substances legislation, promotes reduction of illegal substances, and bring offenders to justice.

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Environmental Protection Agency (EPA)

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This agency focuses on the protection of the environment and the health of human beings.

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Food and Drug Administration (FDA)

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Promotes public health by controlling the safety and effectiveness of foods, drug, biological products, medical devices, cosmetics, and radioactive substances.

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The Joint Commission

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This agency is a not-for-profit, independent organization that accredits and certifies health-care organizations in the United States.

It strive for continual quality improvement so that accredited organizations offer increased patient safety.

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National Association of the Boards of Pharmacy (NABP)

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Promotes public health by implementing standards to reduce potential public harm that can result because of the increasing complexity of medications and medication delivery system.

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State Board of Pharmacy (BOP)

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Regulated by each states to control the practice of pharmacy within the states.

Each state board of pharmacy is part of the state Department of Health (DOH)

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United States Pharmacopeia

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This is the official authority that sets standards for all prescription and OTC medications and it standardizes dietary supplements and other healthcare products made and sold in the United States.