Fdc tuyển dụng 2023

•Result of 15 years of intense lobbying efforts
-By Brand and Generic Drug Firms
-Both Needed Something Important

Nội dung chính

• What was the purpose of the Food Drug and Cosmetic FDC Act of 1938 quizlet?
• What does the Food Drug and Cosmetic Act do for consumers quizlet?
• What is the Food Drug and Cosmetic Act of 1938?
• What is the purpose of the Federal Food Drug and Cosmetic Act?

•Streamlining of generic drug approval process
-"Abbreviated New Drug Application"
-Demonstration of Bio-equivalency = sufficient now
•
•"Patent term extensions" to brand name drugs
-Compensate for length of FDA Review process
-Extension capped at 5 extra years

•Applies equally to U.S. drugs and imports
•
•FDA cooperated with the U.S. Patent Office
•
•Requires FDA to publish the "Orange Book"
-Bio-equivalency of "brand" to "generics"
-
•Didn't cure all ills of FDA drug review process

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1. Social Science
2. Law
3. Civil Law

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Terms in this set [43]

Pure Food and Drug Act of 1906

-Required drugs to be safe, but no pre-approval process
-Criminal penalty for violations
-No adulteration or misbranding
-USP standards of purity and quality followed unless manufacturing standards declared on the label

Sherley Amendment [1912]

A drug is misbranded if the drug makes false therapeutic claims

Purpose of FD&C

Limit interstate commerce to drugs proven safe and effective; prevents adulteration and misbranding of products

Elixir Sufanilamide Disaster of 1937

Antifreeze [diethylene glycol] was used in a medication and it killed many people - considered misbranding because it did not meet definition of an elixir

Could not be removed due to safety issues because FDA did not hold this power at the time - only removed due to the elixir misbranding

Proved that the Pure Food and Drug Act of 1906 did not work --> FD&C of 1938 creation

Requirements of FD&C

-FDA had to declare drugs safe before marketing
-Labels must have directions for use for consumer

Durham-Humphrey Amendment of 1951

-Established category of RX and OTC drugs and labeling requirements [legend drugs]
-Exemption from the rule that label of drugs has directions for consumer b/c it can be directed at pharmacist or doctor instead
-Allows oral prescriptions and refills

Legend drugs

RX drugs; must contain on the label

Caution: Federal law prohibits dispensing without a prescription

Thalidomide Disaster of 1961

Taken by pregnant women for N/V in Europe, but was actually causing birth defects

This led to the FDA withholding approval in the USA - FD&C did its job

Kefauver-Harris Amendment of 1962

-New drugs must be proven safe AND effective before marketing
-Drugs before 1938 given grandfather status and can stay on the market if nothing changes including labeling
-Drugs between 1938 and 1962 must be proven safe and effective

-Requires informed consent and adverse effect reporting in clinical trials
-RX advertising given from FTC to FDA
-Established good manufacturing practices

Drug Efficacy Study Implementation [DESI]

Established by the FDA to review all products between 1938 and 1962 and determine if they are effective, since they were already proven safe

Conducted by National Academy of Sciences/National Research Council

New England Compounding Center

Had a recall because fungus inside of a steroid spinal injection was causing meningitis

Drug Quality and Security Act of 2013 [DQSA]

Created outsourcing facilities that must register with the FDA and comply with good manufacturing practices; do not have to be a pharmacy

Official compendium

the United States Pharmacopeia and the National Formulary [USP/NF]; official listing of recognized drugs in the US; and Homeopathic Pharmacopoeia of the United States; official compendia for homeopathic products in the US

Plus any supplements to these

Food

Articles used for food or drink for human or animals, gum, and components of these articles

Food additive

Directly or indirectly affects the characteristic of the food - all must be approved

EX: Packaging is indirect, preservative is direct

Drug

1] Recognized in the USP/NF/HUSP
2] Articles intended to diagnosis, treat, or prevent disease
3] Components of these articles
4] Structure-function claims

Structure function claim example

St Johns Wort impacts levels of serotonin in the brain [does not outright say depression]

New drug

Drugs that have not gone through the FDA process yet to be proven safe and effective - once it is approved its no longer considered new

Counterfeit drug

Drug bears the trademark of a manufacturer that did not actually manufacture it

Device

Apparatus that is recognized by the USP/NF or intended to diagnosis/treat/prevent disease or affects structure-function of the body

AND does not complete its purpose through chemical action within the body or metabolism

Cosmetic

Applied to the human body for altering appearance and any components of this article; does not include soap

Label vs labeling

Label - Anything directly on the container
Labeling - Directly on the container or accompanying information like a package insert

Tobacco

Any product derived from tobacco for human consumption

Dietary supplement

Product intended to supplement the diet containing...
-Vitamin
-Mineral
-Herb
-Amino acid
-Increases dietary intake
-Metabolite or extract of anything described above

Not considered a food, drug, or food additive; it has its own category --> NOT OTC DRUGS

EX: St. John's Wort, Ginseng, Gingko, Saw Palmetto

Dietary Supplement Health and Education Act of 1994 [DSHEA]

Allows non-drug structure function claims
Can change a supplement into a drug but not a drug into a supplement

Major claim types

Structure-function: Must be truthful and does not need premarket approval

Health claim: Must have relationship between substance and disease; needs premarket approval

Drug claim: Subject to drug regulations; must cure, treat, prevent, or diagnosis

Labeling exclusions

If the information is reprinted in entirety and used in connection with sales; must be physically separated from the product and cannot say treatment on the cover page

EX: Brochure

Adulteration & Misbranding

FDA has burden of proof, but courts cannot defer to them; instead company has to prove it is not misbranded or adulterated

Considered this if it has harmful substance in it or has risk of illness under conditions of use on the label

OTC drugs

Must also be proven safe and effective
Labeled for the consumer and label regulated by the FDA

Federal Trade Commission [FTC]

Regulates advertising of OTC drugs

Orphan Drug Act

Incentives for manufacturers to make drugs for these diseases by giving 7 yrs of market exclusivity

Prescription Drug Marketing Act

Requirements for drug samples, prevents reselling drugs from hospitals, regulates wholesalers, and bans reimporting American made drugs except by the manufacturer

PDUFA and GDUFA

PDUFA --> Manufacturers pay fees for NDAs
GDUFA --> Generic manufacturers pay fees for ANDAs

Prescription drug user fee amendment
Generic drug user fee amendment

United States vs Johnson

Showed weakness of Pure Food and Drug Act of 1906

Misbranding did not prevent false claims - only in relation to drug strength, quality, and purity - which led to manufacturers omitting label information out of fear of violation

Amendment in 1912 prevented false claims, but was difficult to prove fraudulent intent and enforce the amendment

Food Additives Amendment of 1958

Components of food must have premarket safety approval and contains the Delaney Clause which says that no additive can be linked to cancer

Color Additive Amendments of 1960

Safety of color additives must be established premarket and cannot cause cancer; a color can be approved for one use but not others

Drug Price Competition and Patent Term Restoration Act of 1984

Waxman-Hatch Amendment

Gives patent extensions to innovative drugs and streamlines generic approval

Food and Drug Administration Modernization Act of 1997

Requires FDA to define scope of responsibility in a mission statement and publish compliance plans after consulting with healthcare professionals and industry representatives

Creates fast track approvals for life saving drugs/medical devices and creates a data bank of clinical trial information

Expands authority on OTC drugs and ingredient labeling requirements

How does the FDA work?

Component of the Department of Health and Human Services, in which the commissioner is appointed by the President and Senate

Divided into five offices
-Our main focus is Office of Medical Products and Tobacco

Receives advice from outside experts on advisory committees

Medical food

A food to be taken under the supervision of a physician and intended for the dietary management of a disease/condition for which distinctive nutritional requirements are established by scientific evaluation

Not considered a drug nor is special dietary foods

Ephedra

Dietary supplement removed from the market due to its lack of safety

Supplement and Nonprescription Drug Consumer Protection Act of 2006

Requires supplement manufacturers to warn of adverse events

DHSEA criticisms

Makes it hard to remove unsafe supplements off of the market and prevents FDA from evaluating unsafe products premarket

FDA requires supplements to undergo good manufacturing practices, but cannot inspect products prior to marketing

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What was the purpose of the Food Drug and Cosmetic FDC Act of 1938 quizlet?

The United States Federal Food, Drug, and Cosmetic Act [abbreviated as FFDCA, FDCA, or FD&C], is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration [FDA] to oversee the safety of food, drugs, and cosmetics.

What does the Food Drug and Cosmetic Act do for consumers quizlet?

The Pure Food and Drug Act of 1906 prohibited the sale of misbranded or adulterated food and drugs in interstate commerce and laid a foundation for the nation's first consumer protection agency, the Food and Drug Administration [FDA].

What is the Food Drug and Cosmetic Act of 1938?

FDR signed the Food, Drug, and Cosmetic Act on 25 June 1938. The new law brought cosmetics and medical devices under control, and it required that drugs be labeled with adequate directions for safe use.

What is the purpose of the Federal Food Drug and Cosmetic Act?

The enactment of the 1938 Food, Drug, and Cosmetic Act tightened controls over drugs and food, included new consumer protection against unlawful cosmetics and medical devices, and enhanced the government's ability to enforce the law.