2025 Louisiana Pharmacy Law Review Flashcards

A comprehensive set of 175 vocabulary flashcards covering Louisiana pharmacy law, federal drug regulations, and clinical practice standards.

Food, Drug and Cosmetic Act of 1938

Legislation passed in response to the Sulfonamide issue of $1937$ and ongoing drug misuse; it defined what a 'New Drug' was and how it was approved.

Sulfonamide issue of 1937

One of the two primary historical issues that led to the passage of the FDCA of $1938$.

FDCA 1938 Batch Process

A requirement of the $1938$ act for certain products to ensure consistency and quality.

FDCA 1938 Scope

Included medical devices and cosmetics in addition to drugs.

FDCA 1938 Safety Requirement

Required documentation of safety only for a New Drug to be approved for human use.

Levothyroxine products

A specific group of medications that are no longer exempted from the FDCA via the historical product loophole.

Rx Only class

A medication class created by the FDCA of $1938$, also applicable to intrastate commerce.

Durham-Humphrey Amendment of 1951

Update to the FDCA which clarified the role of the prescription and the pharmacist, including the legality of oral prescriptions and refills.

Oral Prescriptions (Durham-Humphrey)

Authorized if the prescription is written down immediately by the pharmacist.

Durham-Humphrey Labeling

Clarified that prescriptions needed labeling showing they were available by prescription only, though patient labeling was not required.

Kefauver-Harris Amendment of 1962

Requires extensive animal, pharmacological, and toxicological testing prior to use in humans and submission of an IND followed by an NDA.

IND (Kefauver-Harris)

Investigational New Drug application required before human trials can begin.

Effectiveness Requirement (1962)

Mandated that drugs (including those approved from $1938$ to $1962$) must be shown to be effective, not just safe.

Drug Advertising Regulation

The FDA regulates advertising for drugs (excluding OTCs) as established by the Kefauver-Harris Amendment.

GMP (Kefauver-Harris)

Good Manufacturing Processes; a standard required for the production of pharmaceuticals.

FDCA Definition of 'Drug' (Articles in Compendia)

Articles recognized in the United States Pharmacopeia, Homeopathic Pharmacopeia of the United States, or National Formulary.

FDCA Definition of 'Drug' (Therapeutic Intent)

Articles intended for use in the diagnosis, treatment, cure, mitigation, or prevention of disease in man or animals.

Counterfeit Drug

A drug or container which, without authorization, bears the trademark, trade name, or identifying mark of a drug manufacturer, processor, packer, or distributor.

Device

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article recognized by the USP/NF.

Device Mechanism of Action

Unlike drugs, these do not achieve primary purposes through chemical action or metabolism.

Cosmetic

Articles intended to be rubbed, poured, sprinkled, or sprayed on the human body for cleansing, beautifying, or altering the appearance.

Soap Exception

Specifically excluded from the definition of a 'Cosmetic' under the FDCA.

Dietary Supplement

A product intended for ingestion that contains a 'dietary ingredient' intended to supplement the diet.

Dietary Ingredient Examples

A vitamin, mineral, herb, botanical, amino acid, or dietary substance used to supplement the diet.

New Dietary Ingredient Date

Any dietary ingredient marketed after October $15$, $1994$.

Physician Assistants (Prescribing)

Authorized to prescribe by formulary with a supervising MD or DO.

Nurse Practitioners (Prescribing)

Authorized to prescribe by formulary with a supervising MD or DO in Louisiana.

Authorized Prescribers in LA

Physicians, PAs, NPs, Optometrists, Medical Psychologists, and Veterinarians.

Self-prescribing

Considered acceptable based on the reviewed Louisiana pharmacy law materials.

Reasons to Refuse a Script (Safety)

A pharmacist believes the drug product may be harmful to the patient.

Reasons to Refuse a Script (Legality)

Suspected forgery, fictitious nature, or if filling it would result in a violation of law.

Prescription Ownership (Prior to Filling)

The prescription belongs to the patient.

Prescription Ownership (After Filling)

The prescription belongs to the pharmacy.

Prescription Storage (FDCA)

Records may be audited for up to $5$ years.

Prescription Storage (Medicare Modernization Act of 2003)

Records may be audited for up to $10$ years.

Federal Labeling Requirement: Serial Number

The prescription number that must appear on the drug label.

Federal Labeling Requirement: Writing/Dispensing Date

The date when the prescription was written or dispensed must be on the label.

Federal Labeling Requirement: Prescriber

The name of the practitioner who authorized the drug.

Information NOT required by Federal Law for Labels

Expiration dating, lot numbers, name of drug, manufacturer, or strength.

Manufacturer Expiration Dating

Dating established by the manufacturer for a commercial drug product.

Unit Dose Expiration Dating

Dating for a package prepared from a bulk container of a commercial drug product.

Beyond-Use Dating (BUD)

Expiration dating for individual prescriptions being dispensed by a pharmacist.

Poison Prevention Act of 1970

Created requirements for 'special packaging' to prevent children under five from obtaining harmful amounts of substances.

Special Packaging Definition

Packaging designed to be significantly difficult for children under five to open within a reasonable time, while not difficult for normal adults to use.

Child Resistant Standard: Child Fail Rate

Not more than $20\%$ of children from a test group can get into the packaging.

Child Resistant Standard: Adult Pass Rate

Not more than $10\%$ of adults from a test group cannot get into the packaging.

Recycling Vials

Plastic vials should not be recycled due to wear; glass vials may be recycled.

PPPA Exclusions: Authorized Party

A prescriber can make a one-time exclusion; a patient can make single or blanket exclusions.

Nitroglycerin SL exclusion

Specifically excluded from the Poison Prevention Act requirements.

Isosorbide Dinitrate SL limit

Excluded if the dose is $10\,mg$ or less.

Erythromycin Ethylsuccinate (EES) Granules limit

Excluded if the package contains not more than $8\,g$.

Erythromycin Ethylsuccinate (EES) Tablets limit

Excluded if the package contains not more than $16\,g$.

Potassium Supplement limit (PPPA)

Excluded if in limited package forms containing not more than $50\,MEq$.

Sodium Fluoride limit (PPPA)

Excluded if the amount does not exceed $264\,mg$.

Betamethasone tablet limit (PPPA)

Excluded if no more than $12.6\,mg$ per package.

Prednisone limit (PPPA)

Excluded if the package contains less than $105\,mg$.

Mebendazole tablet limit (PPPA)

Excluded if the package contains no more than $600\,mg$.

Methylprednisolone limit (PPPA)

Excluded if the package contains less than $84\,mg$.

Colestipol powder limit (PPPA)

Excluded if the package contains less than $5\,g$.

Pancrelipase

Preparations of this enzyme are excluded from Poison Prevention Act requirements.

Conjugated Estrogen tablet limit (PPPA)

Excluded if the package contains less than $32\,mg$.

Anti-Tampering Act Penalty

Tainting a consumer product with intent to cause injury can result in a fine or imprisonment for up to $3$ years.

Tamper Evident definition

A package having an indicator or barrier to entry which, if breached, provides visible evidence of tampering.

Drug Price Competition and Patent Term Restoration Act of 1984

Also known as Waxman-Hatch, it balanced brand patent rights with generic rights via the ANDA process.

ANDA

Abbreviated New Drug Application used by generic manufacturers to show bioequivalence.

Bioavailability

The rate and extent to which the active drug ingredient is absorbed and becomes available at the site of action.

Generic Drug Bioequivalence Tolerance

Generic drugs are permitted to vary by $-20\%$ to $+20\%$ compared to the brand, though most are within $\pm 3.5\%$.

Generic Substitution: Prior Consent

A physician can request it once per script; a patient can issue a blanket request.

Orange Book

Officially titled 'Approved Drug Products with Therapeutic Equivalence Evaluations,' first created in $1979$.

A-Rated Products

Products the FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products.

AA Rating

Products in conventional dosage forms with no equivalence problems.

AN Rating

Solutions and powders for aerosolization.

AO Rating

Injectable oil solutions.

AP Rating

Injectable aqueous solutions and certain IV non-aqueous solutions.

AT Rating

Topical products with therapeutic equivalence.

B-Rated Products

Drug products that the FDA does not at this time consider to be therapeutically equivalent.

BC Rating

Extended-release dosage forms with potential or actual bioequivalence problems.

BD Rating

Active ingredients and dosage forms with documented bioequivalence problems.

BE Rating

Delayed-release oral dosage forms.

BN Rating

Products in aerosol-nebulizer drug delivery systems.

BP Rating

Active ingredients and dosage forms with potential bioequivalence problems.

BS Rating

Products having drug standard deficiencies.

BX Rating

Products for which data are insufficient to determine therapeutic equivalence.

AB Rated Product Definition

A product shown through in vivo or in vitro testing to have the same rate and extent of absorption as the reference product.

AB1 vs AB2

Sub-categories used when there is more than one type of reference drug for a generic.

Warner-Lambert v. Shalala

Legal case determining that for drug classification, the outer form (e.g., a capsule containing a tablet) is what defines the product.

Biologics Price Competition and Innovation Act

Created the framework for biosimilars as part of the Affordable Care Act.

Purple Book

Lists licensed biological products with biosimilarity or interchangeability evaluations.

Biosimilar Interchangeability

A biosimilar must be biosimilar to an FDA-approved reference product to be interchangeable.

Semglee

An interchangeable biosimilar for insulin glargine ($insulin\,glargine-yfgn$).

Drug Patent Life

Standard term of $20$ years.

Pediatric Exclusivity

Provides an additional $6$ months of marketing exclusivity.

New Chemical Entity (NCE) Exclusivity

Provides $5$ years of marketing exclusivity.

GAIN Act Exclusivity

Generating Antibiotic Incentives Now; provides $5$ years of exclusivity.

Orphan Drug Exclusivity

Provides $7$ years of marketing exclusivity for drugs treating rare diseases.

Generic Drug Market Exclusivity

The first generic to market has $180$ days of exclusive generic market rights.

Biologics Market Exclusivity

Biological products have $12$ years of market exclusivity.

Bober v. Glaxo-Wellcome

Case concerning legal ramifications of substituting multiple OTC doses for an equivalent Rx strength.

Mailing Prescriptions: USPS

Permitted by USPS as long as the medication is not a poison or an alcoholic beverage.

OBRA 90 Medicaid Impact

Altered rules regarding Medicaid to include DUR, counseling, and histories.