2026 Student’s Guide to Federal and Missouri Pharmacy Law - Packet 1

Comprehensive vocabulary flashcards covering basic federal definitions, adulteration/misbranding, compounding, prescribing authority, labeling, and the Controlled Substances Act.

Law

A body of principles that govern conduct and can be enforced in courts, aiming to resolve disputes without force and reflect societal values.

Statute

A written law enacted by a legislature (Congress at the federal level) and signed by a President/Governor; found in the United States Code (USC).

Regulation (Rule)

A rule having the force of law issued by an administrative agency (e.g., FDA, DEA) that provides detailed enforcement information; found in the Code of Federal Regulations (CFR).

Drug

An article recognized in an official compendium, intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect the body's structure or function.

Official Compendium

The United States Pharmacopeia (USP), National Formulary (NF), and Homeopathic Pharmacopeia of the United States (HPUS).

Prescription Drug

A drug that, due to toxicity or other potential for harm, is not safe for use except under the professional supervision of a licensed practitioner.

Label

Any printed, written, or graphic material placed specifically on the product container.

Labeling

A broad term including the label on the container plus any accompanying material, such as package inserts, advertisements, or medication guides.

Adulteration

Issues relating to a drug's composition, strength, purity, or quality, such as being filthy, putrid, decomposed, or failing to meet compendial standards.

Misbranding

Issues relating to the words, labeling, or packaging of a drug, such as false/misleading info, missing directions, or violating the Poison Prevention Packaging Act.

503A Compounding

Traditional pharmacy compounding for an individual patient based on a valid prescription; exempt from cGMP, misbranding, and new drug requirements.

503B Compounding

Outsourcing facilities that compound larger batches without patient-specific prescriptions; must follow cGMP and specific labeling requirements.

Big Four Prescribers

Physicians (MD/DO), Dentists (DDS/DMD), Podiatrists (DPM), and Veterinarians (DVM); recognized for full prescribing authority in all US jurisdictions.

Agency Law

Allows a 'principal' (prescriber) to authorize an 'agent' (nurse/staff) to communicate prescriptions to a pharmacy, though agents cannot make clinical decisions.

Special Packaging

Also known as child-resistant containers (CRC); designed to be significantly difficult for children under 5 to open within a reasonable time.

Patient Package Insert (PPI)

FDA-approved patient-friendly labeling required to be dispensed with all estrogens and oral contraceptives.

Medication Guide (MedGuide)

FDA-approved labeling for drugs with serious risks; must be provided with every new and refill prescription in the outpatient setting.

Orange Book

The FDA publication 'Approved Drug Products with Therapeutic Equivalence Evaluations,' used to determine generic drug substitutability.

Purple Book

The FDA resource listing biological products, including biosimilar and interchangeable biological products.

Controlled Substance

A drug or other substance with dependence liability or potential for abuse, classified into schedules I through V.

DEA Form 222

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

Narcotic

Legally defined as drugs derived from opium, opiates, poppy straw, coca leaves, or cocaine.

Corresponding Responsibility

The legal doctrine stating that while the prescriber is responsible for proper prescribing, the pharmacist bears an equal responsibility for proper dispensing.

Red Flags

Indicators that a prescription may not be for a legitimate medical purpose, such as unusual quantities, antagonistic drug combinations, or patients traveling long distances.

DEA Form 106

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

DEA Form 41

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

Biennial Inventory

A complete and accurate record of all controlled substances on hand, required to be taken at least once every two years.