Texas MPJE 2025 Study Guide Vocabulary

Comprehensive vocabulary flashcards covering Federal and Texas pharmacy laws, controlled substance schedules, pharmacy classifications, and compounding regulations for the 2025 MPJE.

Food, Drug, and Cosmetic Act of 1938

Legislation passed after Sulfanilamide deaths in 1937 that required drugs to be proven safe prior to marketing and established the FDA.

Durham-Humphrey Amendments of 1951

Established two drug classes (prescription and OTC) and authorized verbal scripts and refills.

Kefauver-Harris Amendments of 1962

Amended the FDCA to require drugs to be proven both safe and effective; it also established Good Manufacturing Practices (GMP) and moved Rx advertising jurisdiction to the FDA.

Prescription Drug Marketing Act of 1987

Prohibits re-importation of drugs by anyone except the manufacturer, bans the sale of samples, and regulates the resale of drugs by hospitals.

Adulteration

Refers to a drug that is filthy, putrid, decomposed, prepared under unsanitary conditions, or whose strength/purity differs from the official compendium or label.

Misbranding

Refers to a drug with false or misleading labeling, missing required manufacturer info, or lacking 'Rx Only' legends or adequate directions for use.

503A Pharmacy

A pharmacy that compounds medications pursuant to a specific prescription for an individual patient; they may ship interstate up to $50\%$ of scripts if an MOU with the FDA exists.

503B Facility

An outsourcing facility permitted to compound sterile pharmaceuticals without patient-specific prescriptions; they must register with the FDA and follow cGMP.

Drug Supply Chain Security Act (DSCSA)

Mandates a national track-and-trace system for pharmaceuticals involving transaction information, history, and statements to be maintained for $6$ years.

Standardized Numerical Identifier (SNI)

A product identifier composed of the National Drug Code (NDC) and a unique serial number.

Phase 1 Clinical Studies

Initial human testing involving $20-80$ healthy volunteers to focus on safety and side effects.

Phase 2 Clinical Studies

Testing in $12-300$ people with a specific disease to determine efficacy and continue safety evaluation.

Phase 3 Clinical Studies

Large-scale testing in $300-3,000$ people to assess safety and efficacy in different populations and drug combinations.

Class I Recall

A recall for products with a reasonable probability of causing severe injury or death.

Class II Recall

A recall for products that could pose moderate danger or cause temporary/medically reversible adverse events.

Class III Recall

A recall for products unlikely to cause an adverse health event.

Pharmaceutical Equivalence

Drug products with identical dosage forms, routes of administration, and identical amounts of the same active ingredient.

Therapeutic Equivalence

Pharmaceutical equivalents that are bioequivalent and can be expected to have the same clinical effect and safety profile.

Poison Prevention Packaging Act (PPPA)

1970 law requiring child-resistant containers for prescription and certain over-the-counter drugs.

Schedule I Controlled Substances

Substances with no currently accepted medical use, a high potential for abuse, and a lack of accepted safety (e.g., Heroin, LSD, Marijuana).

Schedule II Controlled Substances

Substances with an accepted medical use but a high potential for abuse leading to severe psychological or physical dependence (e.g., Opioids, Cocaine).

Schedule III Controlled Substances

Substances with lower abuse potential than I or II, lead to moderate/low physical or high psychological dependence (e.g., Tylenol #3, Ketamine).

Schedule IV Controlled Substances

Substances with a low potential for abuse relative to Schedule III (e.g., Xanax, Valium, Tramadol).

Schedule V Controlled Substances

Substances with low abuse potential relative to Schedule IV, often used for antitussive, antidiarrheal, or analgesic purposes (e.g., Robitussin AC).

DEA Form 222

The form used for ordering Schedule I and II controlled substances and for returning Schedule IIs to a supplier.

DEA Form 106

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

DEA Form 41

The document used to record the disposal and destruction of scheduled drugs.

PMP (Prescription Monitoring Program)

A database that pharmacists must check for Opioids, Benzos, Barbiturates, or Carisoprodol before dispensing.

Class A Pharmacy

A license designated for community pharmacies in Texas.

Class B Pharmacy

A license designated for nuclear pharmacies in Texas.

Class C Pharmacy

A license designated for institutional or hospital pharmacies in Texas.

Class D Pharmacy

A license designated for clinic pharmacies in Texas.

Class F Pharmacy

A license designated for Freestanding Emergency Medical Care Facilities in Texas.

Aqueous Preparation

A compounded preparation with a water activity equal to or greater than $0.6$; non-preserved versions have a $14$-day refrigerated BUD.

Non-Aqueous Preparation

A compounded preparation with a water activity less than $0.6$; oral liquids have a $90$-day BUD.