Overview of Pharmacy Law and Regulations

These flashcards cover key vocabulary and concepts related to pharmacy law and regulations, essential for understanding the legal framework governing pharmacy practice.

Constitutional Law

U.S. Constitution that outlines the organization of the federal government and mandates that all laws conform to its principles and rights.

Statutes

Laws passed by legislatures, including federal, state, or local laws.

legislative intent 

laws and regulations are based based on legislative intent which are determined by court opinions “case law” 

Regulatory Agencies

Organizations responsible for overseeing laws and regulations related to specific sectors, such as health and safety.

CDC

Centers for Disease Control and Prevention. Protects public health by investigating, identifying, preventing, and controlling diseases. Oversees various institutes and centers.

CMS

Centers for Medicare and Medicaid Services. Regulates Medicare, Medicaid, SCHIP, HIPAA, CLIA, and other health programs. Conducts inspections to ensure compliance.

DEA

Drug Enforcement Administration. Regulates legal trade in narcotic and dangerous drugs. Manages national narcotics intelligence and combats illegal drug trafficking.

TJC

The Joint Commission. Accredits healthcare organizations and enforces quality and safety standards. Evaluates hospitals, nursing homes, and other healthcare facilities

Food and Drug Administration (FDA)

Agency that ensures the safety, efficacy, and security of drugs, medical devices, and foods; oversees the approval of drug applications.

Controlled Substance Act

Federal law that regulates the manufacture and distribution of narcotics and dangerous drugs, establishing schedules based on their potential for abuse.

MedWatch Program

A system for reporting adverse reactions and product quality issues related to drugs and medical devices, managed by the FDA.

OSHA

occupational safety and health administration. U.S. department of labor that enforced the Occupational Safety and Health Act, ensuring worker safety.

SBOP

State Boards of Pharmacy. Responsible for pharmacy regulations. Each state has it’s own state boards of pharmacy. Regulate pharmacy practice in each state. 

State pharmacy law

• actual pharmacy practice; sets standards

• licenses pharmacies and professionals 

• may ADD restrictions to FEDERAL LAWS

Federal Pharmacy Law 

• Pharmaceutical manufacturing, marketing, and distribution

• conflicts between federal and state laws are resolved by going with the STRICTER law.

DEA Number

• two letter, seven digit code

• A DEA number is mandatory for prescriptions for controlled substances

Pure food and Drug Act

• 1906

• Introduced federal inspection of MEAT PRODUCTS

• did not regulate cosmetics

• Lacked authority to ban unsafe drugs or demand proper drug labeling.

Sherley Amendment 

• 1912

• Prohibited labeling medicines with false therapeutic claims to deceive consumer.

FDCA

• Food, Drug, and Cosmetic Act 

• 1938

• caused by sulfanilamide disaster of 1937.

• Regulated drug labeling and prescribing of legend (prescription-only) drugs

• established by FDA

Durham-Humphrey Amendment 

• 1951

• prescription drug amendment

• "Caution: Federal law prohibits dispensing without a prescription."

• replaced with “Rx only”

FHSA

• Federal Hazardous Substance Labeling Act

• 1960

• regulate hazardous substances; requires labels of potential hazards

• toxic, corrosive, irritants, sensitizers, flammable, and pressure-generating items

Kefauver-Harris Amendment 

• 1962

• Drug Efficacy amendment

• Established Good Manufacturing Practices (GMPs)

• required proof of new drug effectiveness and safety

• Created procedures New Drug Applications (NDAs)

Controlled Substances Act

• 1970s

• related to narcotics, stimulants, depressants, and designer drugs

• established DEA

• created five substance schedules

Schedule I

• C-I

• high potential for abuse

• no accepted medical use

• Do not prescribe, stock, or dispense them.

• Heroin, LSD, marijuana

Schedule II

• C-II

• Dangerous medications with high potential for abuse, and for psychological and physical dependence.

• Cocaine, Lortab, morphine, Ritalin Norco

• No refills are allowed; a new prescription required for each dispensing

Schedule III

• C-III

• Medications with moderate to low potential of abuse and dependence 

• Tylenol #3, anabolic steroids

• refills are allowed, but restrictions apply

• refills may be provided up to 5 times in a six-month period from the date of issuance.

Schedule IV

• C-IV

• Medications with low potential for abuse and low risk of dependence

• Valium, Librium 

• refills are allowed, but restrictions apply

• refills may be provided up to 5 times in a six-month period from the date of issuance.

Schedule V

• C-V

• Lowest potential for abuse compared to other schedules with accepted medical use

• Cough medicines with codeine, Some anti-diarrheal medications

• refills are generally allowed 

• some states limit number of refills/ impose time restrictions 

Health Insurance Portability and Accountability Act (HIPAA)

A law that ensures patient confidentiality and privacy, regulates the use and sharing of protected health information (PHI).

Requirements for controlled substance prescriptions:

1. Patients full name and address

2. Prescribers information: prescriber's full name, professional title, and contact details

3. Date of prescriptions

4. Number of refills

5. Prescribers signature

PPPA

• poision prevention packaging act

• 1970

• childproof packing for controlled drugs

• require a written request for non-childproof packaging by patients

OSHA

• Occupational Safety and Health Act

• 1970

• Ensures workplace and worker safety

• employers provide hazard-free workplaces

• Established National Institute for Occupational Safety and Health (NIOSH) for research and guidance.

Drug Listing Act

• 1972 

• Federal Food, Drug, and Cosmetic Act of 1938

• register their products with FDA 

• Introduced the National Drug Code (NDC)

Medical Device Amendment

• 1976

• premarket approval from FDA for life-sustaining and life-supporting medical devices

Orphan Drug Act

• 1983

• stimulate drug development for rare diseases

• Seven-Year Market Exclusivity

• 50% tax credit

• federal research grants

• FDA fee exemption

Drug Price Competition and Patent Term Restoration Act 1984 (Hatch-Waxman Act)

• 1984

• Manufacturers can seek Abbreviated New Drug Applications (ANDAs) for generic versions of drugs with expiring patents

Prescription Drug Marketing Act (PDMA)

• 1987

• Aims to prevent mislabeled, sub-potent, adulterated, expired, and counterfeit drugs from entering the distribution system.

Anabolic Steroid Control Act (1990)

• Placed anabolic steroids in Schedule III of the Controlled Substances Act (CSA)

Omnibus Budget Reconciliation Act (OBRA '90)

• Focused on Medicare and Medicaid federal funding

• Increased the demand for pharmacy technicians

• Mandated pharmacists to perform drug utilization reviews (DURs) and provide patient counseling

Dietary Supplement Health and Education Act of 1994 (DSHEA)

• Defined dietary supplements and their ingredients

• Established a safety framework for dietary supplements.

• Required ingredient and nutrition labeling

• Granted FDA authority to establish Good Manufacturing Practice (GMP) regulations.

Heath Insurance Prtability and Accountability Act of 1996 (HIPPA)

• ensures patient confidentiality

• right to review medical records

• PHI (protected Heath Information)

FDA Modernization Act of 1997

• made “rx only”

• Streamlined drug approval and access to investigational medicines.

Drug Addiction Treatment Act of 2000

• Allows certain physicians to prescribe pre-approved C-III, C-IV, and C-V medications for opioid addiction treatment.

Medicare Modernization Act of 2003

Introduced Medicare Part D, a voluntary prescription drug benefit plan for seniors

USP Chapter

Established first enforceable standards for sterile compounding