Pharmacy Law and Regulations Practice Flashcards

Comprehensive vocabulary flashcards covering major federal pharmacy laws, regulatory acts, and legal definitions for PTCB preparation.

1906 Pure Food and Drug Act

The first federal law regulating drugs, which required accurate labeling and the purity of products.

1938 Food, Drug, and Cosmetic Act

Legislation that required drugs to be safe and prohibited the adulteration and misbranding of products.

1951 Durham-Humphrey Amendment

An amendment that separated medications into two categories: Prescription (Rx/legend) and Over-the-Counter (OTC).

1962 Kefauver-Harris Amendment

Legislation that mandated proof of efficacy (drugs must be safe and effective) and established Good Manufacturing Practices (GMPs).

1970 Controlled Substances Act (CSA)

A law that created drug schedules $I$-$V$ based on abuse potential and established the Drug Enforcement Administration (DEA).

1970 Poison Prevention Packaging Act (PPPA)

This act required child-resistant packaging for most potentially harmful drugs to reduce accidental poisonings.

1972 Drug Listing Act

An act that established the National Drug Code (NDC) system for listing and identifying drugs.

1983 Orphan Drug Act

A law providing incentives, including research grants and a $50\%$ tax incentive, to develop medications for rare diseases.

1984 Waxman-Hatch Act

Also known as the Drug Price Competition and Patent Term Restoration Act, it encouraged generic drug entry and granted brand market exclusivity.

1990 OBRA '90

The Omnibus Budget Reconciliation Act, which established the roots of pharmacist counseling requirements for Medicaid and Medicare patients.

1996 HIPAA

The Health Insurance Portability and Accountability Act which protects patient privacy and Protected Health Information (PHI).

1997 FDA Modernization Act

This act changed prescription labeling from a long caution statement to the simplified "Rx Only" label.

2003 Medicare Prescription Drug Improvement and Modernization Act

Legislation that added Medicare Part $D$ to assist beneficiaries with the cost of prescription medications.

2005 Combat Methamphetamine Epidemic Act (CMEA)

A law restricting the sale of pseudoephedrine and ephedrine and requiring products to be sold from behind the counter.

Adulteration

A legal term for drugs that are filthy, impure, produced in unsanitary conditions, or have the wrong strength or quantity.

Misbranding

A legal term for drugs with false or misleading labeling, or missing required warnings and information.

NDC Format

A numbering system structured as a $5$-$4$-$2$ sequence representing the manufacturer, product, and package size.

NDC Manufacturer Code

The first segment of the National Drug Code, consisting of $5$ digits identifying the maker of the drug.

NDC Product Code

The middle segment of the National Drug Code, consisting of $4$ digits identifying the specific drug.

NDC Package Size Code

The final segment of the National Drug Code, consisting of $2$ digits identifying the size of the container.

Rare Disease threshold (Orphan Drug Act)

A condition or disease that affects fewer than $200,000$ people in the United States.

Orphan Drug Exclusivity

A period of $7$ years granted to manufacturers for market exclusivity under the Orphan Drug Act.

Poison Prevention Packaging Act (PPPA)

Caps must be designed so that they are difficult for a child of $5$ years old to open.

PPPA Exception: Nitroglycerin

A specific medication that is exempt from child-resistant packaging requirements.

1990 Anabolic Steroid Control Act

Legislation that reclassified anabolic steroids as Schedule $III$ substances due to their potential for serious health consequences.

Protected Health Information (PHI)

Individually identifiable health information that pharmacies must protect under HIPAA policies.

CMEA Daily Purchase Limit

The maximum amount of pseudoephedrine or ephedrine a person can buy in a single day is $3.6\,g$.

CMEA 30-Day Purchase Limit

The maximum amount of pseudoephedrine or ephedrine a person can buy in a thirty-day period is $9.0\,g$.

FDA Legend

A required statement on prescription labels that was originally "Caution: Federal law prohibits dispensing without a prescription."

Good Manufacturing Practices (GMPs)

Mandated standards for drug production quality that were strengthened by the Kefauver-Harris Amendment of $1962$.

Drug Enforcement Administration (DEA)

The federal agency created by the Controlled Substances Act ($1970$) to regulate and enforce drug laws.

Schedule I-V

The classification system for drugs with abuse potential established by the Controlled Substances Act.

Medicare Part D

The specific part of Medicare established in $2003$ to provide prescription drug coverage for all enrollees.

Package Inserts

Detailed drug information documents required by the Kefauver-Harris Amendment to be provided with medications.

Patient Waiver

A legal exception to the PPPA where a patient requests that their medication not be placed in child-resistant packaging.