Laws, Regulations, and Pharmacology Review

Vocabulary flashcards covering pharmacy laws, federal regulations, controlled substances rules, dosage forms, drug classifications, and compounding standards.

Health Insurance Portability and Accountability Act (HIPAA)

The primary federal law of 1996 that directs pharmacy professionals in handling patients' protected health information (PHI) and guards against inappropriate disclosure.

Protected Health Information (PHI)

Any information in a patient's health files collected, created, or stored by pharmacy staff that can identify the individual and relates to their past, present, or future physical or mental health.

National Drug Code (NDC)

A unique identifier required by the Drug Listing Act of 1972 for every medication, consisting of digits representing the labeler, product/drug name and dose, and package size.

Controlled Substances Act (CSA)

Federal law of 1970 regulating the manufacture, importation, possession, use, and distribution of medications with potential for abuse, dividing them into five schedules.

Pharmacy Practice Act

State-specific law governing how pharmacists and pharmacy technicians practice pharmacy within that state, overseen by the state board of pharmacy.

Black Box Warning

A warning required by the FDA on medication package inserts for pharmaceuticals with high-risk potential, detailing serious associated adverse reactions.

MedWatch

An FDA reporting program through which healthcare professionals, manufacturers, and consumers report defects, adverse reactions, or errors related to medical products.

Minimum Necessary Standard

A HIPAA principle requiring pharmacy staff to disclose only the minimal amount of PHI needed by another party to fulfill a specific task or process a claim.

Prescription

An order that conveys a prescriber's medication treatment plan for a patient to a pharmacist.

Five Rights of Medication Administration

Core safety principles ensuring the right patient, right medication, right strength, right route, right dose, and right time.

Omnibus Budget Reconciliation Act of 1990 (OBRA '90)

Federal legislation requiring pharmacies to maintain patient profiles, conduct drug utilization reviews, and offer counseling to Medicaid patients.

Drug Utilization Review (DUR)

An authorized, structured, ongoing review of provider prescribing, pharmacist dispensing, and patient use of medication to reduce therapy errors.

Orange Book

The FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, which serves as the primary reference for bioequivalence.

Poison Prevention Packaging Act of 1970 (PPPA)

Law requiring child-resistant packaging designed so that 80% of children under 5 cannot open it and at least 90% of adults can open it within 5 minutes.

Sharps Disposal Container

A rigid, impenetrable, leakproof, closable container marked with a biohazard symbol used for the safe immediate disposal of skin-penetrating items like needles and blades.

Hazardous Drugs (HD)

Medications that cause serious side effects in testing, or may cause organ damage, cancer, or harm to a pregnant person, regulated under OSHA and USP 800.

DEA Form 222

A single-sheet paper form used by authorized registrants to order Schedule II (C-II) controlled substances.

Controlled Substance Ordering System (CSOS)

An electronic ordering system allowing pharmacies to order Schedule II controlled substances using digital certificates instead of paper Form 222.

DEA Form 41

A Drug Enforcement Administration form used by pharmacists to document and report the disposal or destruction of controlled substances.

DEA Form 106

A Drug Enforcement Administration form used by pharmacies to report the theft or significant loss of controlled substances.

Combat Methamphetamine Epidemic Act of 2005 (CMEA)

Federal law regulating retail sales of behind-the-counter OTC products containing ephedrine, pseudoephedrine, or phenylpropanolamine, setting sales limits of 3.6 grams per day and 9 grams per 30 days.

Biologic

A large, complex molecule produced using living organisms, such as bacteria, yeast, or animal cells, rather than synthetic chemical processes.

Biosimilar

A biologic medication approved by the FDA that is highly similar to and therapeutically equivalent to a reference biologic product.

Purple Book

The FDA reference list that provides information on biological products, reference products, biosimilars, and their interchangeability.

Therapeutic Equivalence

A designation indicating two drugs are bioequivalent, contain the same active ingredient and dose, share the same route/form, and have the same clinical effect and safety profile.

Enteric-coated Tablets

Tablets coated to delay absorption until passing through the stomach to avoid irritating the stomach lining.

Buccal Tablets

Tablets placed between the cheek and gums where active ingredients absorb directly through the cheek mucosa into the bloodstream.

Sublingual Tablets

Tablets placed under the tongue that dissolve rapidly and absorb directly into the bloodstream without entering the digestive tract.

Suppositories

Semisolid dosage forms inserted into the rectum, vagina, or urethra that melt at body temperature to deliver local or systemic medication.

Emulsion

A liquid mixture composed of two immiscible liquids (oil and water) maintained in uniform distribution using an emulsifying agent.

Parenteral Route

Medication delivery directly into the body via injection, such as intravenous (IV), intramuscular (IM), intradermal, or subcutaneous routes.

Off-Label Use

The accepted practice of prescribing an FDA-approved medication for an unapproved disease or condition based on professional clinical judgment.

Side Effects

Unintended, expected secondary outcomes occurring at normal therapeutic doses that do not match the primary therapeutic goal.

Adverse Reactions

Undesirable, negative, and potentially harmful or severe outcomes resulting from medication use at standard therapeutic doses.

Absolute Contraindication

A situation where a medication must never be used because the health risk always outweighs any potential therapeutic benefit.

Relative Contraindication

A situation where medication use presents elevated risk and requires clinical caution, balancing benefit against potential harm.

Nonsterile Compounding

The extemporaneous preparation of non-parenteral dosage forms (e.g., capsules, ointments, suspensions) governed by USP 795 standards.

Sterile Compounding

The preparation of parenteral products in a controlled environment using aseptic technique to minimize microbial contamination, governed by USP 797.

Class 100 Environment (ISO 5)

An air quality environment required for sterile compounding containing no more than 100 airborne particles of 0.5 microns or larger per cubic foot.

Vaccine

A biological preparation that stimulates the immune system to produce antibodies against a specific pathogen antigen, conferring active acquired immunity.