Pharmacy Laws and Regulations

Pure Foods and Drugs Act of 1906

Prohibits the interstate transportation or sale of adulterated or misbranded food and drugs

Durham-Humphrey Act of 1951

Established prescription and OTC drug categories

Verbal/phone prescriptions

Prescription refills

Guidelines and regulations for dispensing prescribed drugs

Food, Drugs, and Cosmetic Act of 1938

Created the U.S. Food and Drug Administration

Required new drug applications to be filed with the FDA

Defined Adulteration and Misbranding

Kefauver-Harris Act of 1962

Requires all medication in the U.S. to be pure, safe, and effective

Comprehensive Drug Abuse Prevention and Control Act of 1970

Established “Controlled substances” ratings

Created the Drug Enforcement Agency

Separated controlled substances into 5 categories based on abuse potential and medical use

National All Schedules Prescription Electronic Reporting Act of 2005

Established an electronic system for monitoring the dispensing of controlled substances in SCH 2, 3, and 4

Many state adopted similar legislations

Poison Prevention Packaging Act of 1970

Aimed at reducing accidental poisoning in children by requiring child resistant containers

Cannot be opened by 80% of children <5 years old

Can be opened by 90% of adults

Occupational Safety snd Health Act of 1970

Ensure safe workplaces

Reduced hazards

Maintained a reporting system for injuring

Required use of MSDS (Material Safety Data Sheet)

Drug Listing Act of 1972

Established the 11-digit National Drug Code (NDC)

Orphan Drug Act of 1982

Provides tax incentives and exclusive licensing to manufacturers to develop and market medications for rare diseases

Orphan Medication

Medications used for the treatment of diseases or conditions of which there are fewer than 200,000 cases in the world

Drug Price Competition and Patent Term Restoration Act of 1984

Encouraged the creation of generic and new medications by streamlining generic approval and patent licenses

Prescription Drug Marketing Act of 1987

Prohibits re-importation of drugs into the U.S. by anyone except the manufacturers

Prohibits the sale or distribution of samples by unlicensed individuals

Omnibus Budget Reconciliation Act of 1987

Revised Medicare and Medicaid “Conditions of Participation” regarding long term care facilities and pharmacies

Anabolic Steroid Control of 1990

Established harsher penalties for the abuse of anabolic steroids and their misuse by athletes

Omnibus Budget Reconciliation Act of 1990

Required manufacturers to provide the lowest prices to Medicaid patients

Mandated an offer to counsel every patient

Required “Drug Utilization Reviews”

FDA Safe Medical Devices Act of 1990

Requires tracking of medical devices

Maintenance of records for durable medical equipment like infusion pumps

American with Disabilities Act of 1990 (ADA)

Prevents discrimination against potential employees with disabilities and requires reasonable accommodation

Resources Conservation and Recovery Act

Environmental Protection Agency (EPA) federal guidelines regarding the disposal of hazardous waste

FDA Modernization Act

An update to the Humphrey Act that replaced the long Federal Drug Legend with the “Rx” abbreviation

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Guidelines to prevent adulteration of herbal products and supplements

Requires labels to identify all ingredients, quantities, and what the plant ingredient derives from

HIPAA of 1996

Improves health coverage portability

Combats waste and fraud

Simplifies insurance administration

Maintains patient confidentiality

Isotretinoin Safety and Risk Management Act of 2004

Helps control the use of Accutane due to its potential to cause severe birth defects and psychiatric effects.

Anabolic Steroid Control Act of 2004

Updated the 1990 Act by redefining SCH 3 medications

Increasing substances to 59

Implementing specific handling and recording requirements.

Any Willing Provider Law

Allows any pharmacy to participate in a prescription drug benefit plan if they agree to the plan's terms and conditions

Freedom of Choice Law

Allows a member of a prescription drug plan to select any pharmacy provided the pharmacy agrees to the plan's terms

Prescription Drug Equity Law

Prohibits a drug plan from requiring mail order coverage without also providing non-mail coverage

Medicare Drug Improvement and Modernization Act of 2003 (MDIMA)

Provides voluntary prescription drug benefits to Medicare Part A and D and adds preventative medical benefits for senior citizens

Combat Methamphetamine Epidemic Act of 2005

Placed Ephedrine, pseudoephedrine, and Phenyl-propanolamine in the Controlled Substances schedule

Imposed sale/production restrictions

Medicaid Tamper-Resistant Prescription Act of 2008

Required special prescription pads for Medicaid-paid prescriptions to prevent unauthorized copying, modification, or counterfeiting

United States Pharmacopeia

Sets procedural training and quality assurance requirements for preparing sterile products to protect patients and pharmacy staff from infections

Official public standards-setting authority for prescription and OTC medications, food ingredients, and dietary supplements in the U.S.

Bureau of Alcohol, Tobacco, and Firearms (ATF)

Sets regulations regarding the purchase of tax-free alcohol used in hospitals and clinics

Drug Enforcement Agency (DEA)

Enforces Compliance with the Controlled Substances Act

Monitors records

Issues Form 222 and 41 for the destruction of controlled substances

Institutional Review Board

A board or committee designated by an institution to approve biomedical research in accordance with the FDA

The Joint Commission (TJC)

Accredits healthcare providers such as hospitals and pharmacies

Establishes standards for patient care quality and safetyY

National Association of the Boards of Pharmacy (NABP)

An organization composed of all state boards of pharmacy that discusses trends but has no regulatory authority

State Boards of Pharmacy (BOP)

The regulatory state agency that oversees the practice of pharmacy within a specific state

Beers Criterias / Beers List

A list identifying medications and classes of medications which may be inappropriate for generic use

Prevent risk of Adverse Drug Events.

Risk Evaluation and Mitigation Strategies (REMS)

Crucical safety progrsm managed by U.S. FDA for high-risk medications

i.e. Clozapine requires blood test monitoring

Thalidomide has strict protocols due to severe birth defects