Federal Requirements Glossary

This glossary covers the core vocabulary for the Federal Requirements domain, which makes up about 18.75% of the scored PTCE. This domain focuses on the laws, regulations, and agencies that govern pharmacy practice at the federal level.

ADA (Americans with Disabilities Act)

Federal legislation that prohibits discrimination against individuals with disabilities and requires reasonable accommodations, which can apply to pharmacy access and services.

Adulterated Drug

A drug product that has been contaminated, improperly manufactured, or does not meet official quality standards, making it unsafe or ineffective under the Federal Food, Drug, and Cosmetic Act.

ARCOS (Automation of Reports and Consolidated Orders System)

A DEA reporting system that tracks the flow of controlled substances from manufacture through distribution to the point of sale or dispensing.

Boxed Warning

See Black Box Warning; the strongest safety warning the FDA can require on a drug's labeling.

Certificate of Registration

A document, issued by the DEA, that authorizes a pharmacy or practitioner to handle controlled substances.

CFR (Code of Federal Regulations)

The official compilation of general and permanent rules published by federal agencies, including regulations governing controlled substances found in Title 21.

CII, CIII, CIV, CV

Common shorthand notations for controlled substances in Schedules II, III, IV, and V under the Controlled Substances Act, reflecting decreasing potential for abuse.

Controlled Substance

A drug or chemical whose manufacture, possession, and use is regulated by the federal government due to its potential for abuse or dependence, classified into Schedules I through V.

Controlled Substances Act (CSA)

The federal law that establishes the framework for regulating the manufacture, distribution, and dispensing of controlled substances in the United States.

CSOS (Controlled Substance Ordering System)

An electronic system authorized by the DEA that allows registrants to order Schedule I and II controlled substances electronically instead of using paper DEA Form 222.

DEA (Drug Enforcement Administration)

The federal agency responsible for enforcing controlled substance laws and regulations in the United States.

DEA Form 41

The form used to document the destruction or disposal of controlled substances.

DEA Form 106

The form used to report the theft or significant loss of controlled substances to the DEA.

DEA Form 222

The official order form required for the distribution or transfer of Schedule I and II controlled substances between registrants.

DEA Number

A unique identifier assigned by the DEA to individuals or entities registered to handle controlled substances, required to prescribe or dispense them.

DSCSA (Drug Supply Chain Security Act)

Federal legislation aimed at building an electronic system to trace prescription drugs as they move through the supply chain, helping to prevent counterfeit, stolen, or harmful drugs from reaching patients.

DUR (Drug Utilization Review, OBRA '90)

A requirement stemming from the Omnibus Budget Reconciliation Act of 1990 that pharmacists review prescriptions for potential problems and offer counseling to patients.

Expiration Date

The manufacturer-assigned date after which a drug product is no longer guaranteed to be safe or fully effective.

FDA (Food and Drug Administration)

The federal agency responsible for regulating the safety and efficacy of drugs, biologics, medical devices, and food products in the United States.

FDCA (Federal Food, Drug, and Cosmetic Act)

The foundational federal law that gives the FDA authority to oversee the safety of food, drugs, medical devices, and cosmetics.

Formulary Restriction

A limitation placed on which drugs are covered by a health plan or institution, often influenced by federal or state program requirements.

HIPAA (Health Insurance Portability and Accountability Act)

Federal legislation that establishes national standards to protect patients' health information and regulates its use and disclosure, commonly known for its Privacy Rule.

Investigational New Drug (IND)

An application submitted to the FDA that allows an unapproved drug to be used in clinical trials before it receives full marketing approval.

Kefauver-Harris Amendment

A 1962 amendment to the FDCA that required drug manufacturers to prove both safety and effectiveness of drugs before FDA approval.

Legend Drug

A medication that federal law requires to be dispensed only with a valid prescription, as opposed to an OTC product; the term comes from the required label statement.

Misbranded Drug

A drug product whose labeling is false, misleading, or fails to include required information, in violation of the FDCA.

New Drug Application (NDA)

The formal application a drug manufacturer submits to the FDA requesting approval to market a new drug in the United States.

Orange Book

The FDA publication that lists approved drug products along with their therapeutic equivalence evaluations, used to identify generic substitution options.

Orphan Drug Act

Federal legislation that provides incentives, such as tax credits and market exclusivity, to encourage the development of drugs for rare diseases.

OSHA (Occupational Safety and Health Administration)

The federal agency responsible for setting and enforcing workplace safety standards, including those relevant to handling hazardous drugs in a pharmacy.

OTC Monograph

An FDA regulatory document that establishes the conditions, such as active ingredients, dosing, and labeling, under which an over-the-counter drug category is considered safe and effective without individual premarket approval.

Pedigree

A documented record showing the chain of custody of a drug product as it moves through the distribution supply chain, used to verify authenticity.

Poison Prevention Packaging Act (PPPA)

Federal legislation that requires most prescription and certain OTC medications to be dispensed in child-resistant packaging, unless the patient or prescriber requests an exception.

Post-Marketing Surveillance

The ongoing monitoring of a drug's safety and effectiveness after it has been approved and is available to the public, often through programs like MedWatch.

REMS (Risk Evaluation and Mitigation Strategy)

An FDA-required safety program for certain drugs with serious safety concerns, which may include elements such as prescriber and pharmacy certification, patient monitoring, or restricted distribution.

Schedule I

The controlled substance classification for drugs with a high potential for abuse and no currently accepted medical use in the United States.

Schedule II

The controlled substance classification for drugs with a high potential for abuse that also have an accepted medical use, subject to strict prescribing and dispensing requirements, such as no automatic refills.

Schedule III

The controlled substance classification for drugs with a moderate to low potential for physical dependence and high potential for psychological dependence, which may be refilled up to five times within six months if authorized.

Schedule IV

The controlled substance classification for drugs with a lower potential for abuse relative to Schedule III substances.

Schedule V

The controlled substance classification for drugs with the lowest potential for abuse among controlled substances, some of which may be available without a prescription depending on state law.

State Board of Pharmacy

The state-level regulatory body responsible for licensing pharmacists and pharmacies and enforcing state pharmacy practice laws, which work alongside federal requirements.

Suspicious Order

An order for a controlled substance that is unusual in size, frequency, or pattern, which a registrant is required to identify and report to the DEA.

USP-NF (United States Pharmacopeia-National Formulary)

An official compendium of drug standards, referenced by federal law, that establishes quality, purity, and compounding standards for medications sold in the United States.