P3 Spring - Pharmacy Law - Quiz 1

Quiz 1

1. A drug is... 2. Labeling 3. NDA vs. IDA 4. A state is... 5. A person is...

- Decision that it doesn't need medical supervision with the labeling

OVER-THE-COUNTER (OTC) DRUG: • Only difference between Rx and OTC: - Decision that it doesn't need ___ ___ with the ___ • Some drugs are OTC for some indications and Rx for others: - Bonine/Antivert (Motion sickness/vertigo)

Orphan Drug

1. Are used for a condition that: • Affects less that 200,000 persons in the US OR • Affects more than 200,000 in the US but the cost of developing and making drug will not be recovered from sales in the United States 2. Also called Drugs for Rare Diseases 3. If designated as an orphan drug but is later to found to have another use - DOES NOT LOSE ORPHAN DRUG STATUS

Et. seq

COMMON LEGAL TERMS (5): ___ ___: • Abbreviation, meaning "and the following"

Per se

COMMON LEGAL TERMS (5): ___ ___: • In or by itself

May

COMMON LEGAL TERMS (5): ___: • Not mandatory (when used in statutes)

Shall

COMMON LEGAL TERMS (5): ___: • Something must be done or somebody must do something (when used as part of a statute)

Promulgate

COMMON LEGAL TERMS (5): ___: • To proclaim or declare something officially; to publicize that a law or regulation is in effect

1. United State Pharmacopeia (USP) 2. National Formulary (NF) 3. Homeopathic Pharmacopeia of the United States (HPUS)

DRUG: • An article recognized in the official compendium or any supplement of the official compendium, 1. ___ ___ ___ (USP) 2. ___ ___ (NF) 3. ___ ___ of the ___ ___ (___)

Person

Individual, partnership, corporation, and association Plural of person is persons in the law - not people

Special Packaging

Packaging designed or constructed to be: 1. Significantly difficult for children under five years of age to 2. Open or obtain a toxic or harmful amount of the substance contained therein 3. Within a reasonable time and 4. Not difficult for normal adults to use properly, but 5. Does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time

Investigational New Drug (IND) Application

___ ___ ___ (___) ___: • Application sent to the FDA asking them for an exemption to the NDA requirements in order to investigate and conduct clinical trials on the new drug Full name is Notice of Claimed Exception for an Investigational New Drug

New Drug Application (NDA)

___ ___ ___ (___): •Application sent to the FDA once all clinical trials and data have been collected on a new drug in order to have the drug approved for marketing

Dietary Supplement

___ ___: • A dietary supplement is "a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a) a vitamin; (b) a mineral; (c) an herb or other botanical; (d) an amino acid; (e) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (f) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in © Kristin R Villa - West Lafayette, IN 2018 16 clause (a), (b), (c), (d), or (e)."

Controlled Substance

___ ___: • A drug that has dependence liability and/or the potential for abuse

Prescription Drug

___ ___: • Also called Rx-Only or Legend Drugs • Drugs used by humans • Require supervision for safe and effective use - Supervision is by practitioner - states determine practitioners • Issues with toxicity, potential for harmful effects, way it's used, or collateral measures for use • Are unavoidably unsafe, but are not unreasonably dangerous

Abbreviated New Drug Application (ANDA)

___ ___: • Application used by generic manufacturers to show proof of bioequivalence and proof of acceptable manufacturing practices and controls

Therapeutic Equivalents

___ ___: • Are pharmaceutical equivalents that are likely to have the same clinical and safety profile

Pre-'38 Drugs

___ ___: • Drugs introduced on the market before 1938 and still on the market in 1962. • Most disappeared - some still persist: Thyroid Morphine Codeine Nitroglycerin Others • Assume they're safe (been on the market forever) and assume they're effective (wouldn't still be used otherwise)

Special Packaging

___ ___: • Focus is only on kids under the age of 5. - Normal adults should not have an issue using the packaging. - Kids under the age of 5 should struggle with opening the packaging. - Kids under the age of 5 may still be able to get into the packaging, but it prevents them from obtaining a toxic or harmful amount in a reasonable time.2

Established Name

___ ___: • MORE SIMPLY = 'THIS IS THE GENERIC NAME' 1. Official name OR 2. Official title thereof in the official compendium OR 3. The common or usual name

Pharmaceutical Equivalents

___ ___: • Products with the same active ingredient, same dosage form, and same strength • May differ in some ways, such as look, release mechanism, expiration time, and, within limits, labeling

Drug Efficacy Study Implementation (DESI) Drugs

___ ___: • Started by the 1962 Drug Amendments • Involved drugs introduced onto the market between 1938 and about 1962 - Were known to be safe, but not proven to be effective • Essentially had to prove effectiveness or pull the drug from the market

Orphan Drug

___ ___: • These are used for a condition that "affects less that 200,000 persons in the United States" or a condition that "affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug."11

New Drug

___ ___: •new drug is a drug that is not generally recognized as safe and effective for the condition(s) or in the dosage form it would be prescribed under; or a drug that has been recognized as safe and effective, but has not been used in the condition(s) or in the dosage form for a sufficient amount of time.

Device

___: • "An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (1) recognized in the United States Pharmacopeia, National Formulary, or any supplement of them, and (2) intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in man or other animal, and (3) intended to affect the structure or any function of the body in man or other animal, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purpose."21

Label

___: • A display of WRITTEN, PRINTED, or graphic matter upon the immediate container of any article

Drug

___: • An article recognized in the official compendium or any supplement of the official compendium, 1. United State Pharmacopeia (USP) 2. National Formulary (NF) 3. Homeopathic Pharmacopeia of the United States (HPUS)*** AND • An article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal,*** AND • An article (other than food) intended to affect the structure or any function of the body in man or other animal,*** AND • Articles intended for use as a component of any article specified (1), (2), or (3)

Cosmetic

___: • Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, AND articles intended for use as a component of any such articles; except that such term shall not include soap • Articles can be both a drug and a cosmetic (dandruff shampoo) - No such thing as "cosmeceutical" in the Food, Drug, and Cosmetic Act

Over-The-Counter (OTC) Drugs

___: • Drugs that are safe and effective for use WITHOUT a prescriber's supervision for certain conditions

Territory

___: • Means "any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone

Behind-The-Counter (BTC) Drugs

___: • Third, unofficial class of drugs - May be referred to as "nonprescription under conditions of safe use" • Currently just proposals or state-specific • Exact definition varies - Generally agree that it would include certain drugs sold only by a pharmacist • Can consider some C-V drugs as third class currently - available OTC, from pharmacist, must be logged

State

• A ___ is defined as "any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico"

Drug

• A ___is: 1) an article recognized in the official compendium or any supplement of the official compendium, and 2) an article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal, and 3) an article (other than food) intended to affect the structure or any function of the body in man or other animal, and 4) articles intended for use as a component of any article specified (1), (2), or (3)."

• Devices are only listed in the USP-NF, so there are apparently NO homeopathic devices

• Devices are only listed in the ___, so there are apparently NO ___ devices

Person

• The term, ___, as defined in the law "includes individual, partnership, corporation, and association" - It may not just mean an individual

• Label is a narrow term referring only to the sticker or printed material on the container itself, while • Labeling is more broad and contains all printed information that accompanies a product. • Keep in mind that the definition of labeling includes the label

• ___ is a narrow term referring only to the sticker or printed material on the container itself, while • ___ is more broad and contains all printed information that accompanies a product. • Keep in mind that the definition of ___ includes the ___

Labeling

• ___ is all labels and written, printed, or graphic material on the container, container wrapper, or accompanying the product • All labels and other written, printed, or graphic matter: 1. Upon any article or any of its containers or wrappers, OR 2. Accompanying such article