Law FDCA (Exam 1)
The Jungle by Upton Sinclair
depicted unsanitary meat packing practices in Chicago
1970 Poison Prevention Packaging Act
enacted to protect children from accidental poisonings by household substances
The Nutrition Labeling and Education Act of 1990
states that health claims are permitted without FDA regulation so long as there is "significant scientific agreement" as established by an FDA determination
Once, unless in a glass or threaded plastic container may be reused if a new safety closure is provided
How many times may drugs be dispensed in a child-resistant container?
every 5 years
How often is PDUFA reauthorized?
Definition of a dietary supplement under DSHEA
-A product that is intended for ingestion, is intended to supplement the diet and contains any one or more of the following: A vitamin, A mineral, An herb or other botanical, An amino acid, A dietary substance for use by humans to supplement the diet by increasing the total dietary intake, A concentrate, metabolite, constituent, extract, or combination of the previous
Drug made in a nonregistered establishment
A drug is considered misbranded: TEST
"Established Name" of the drug Each active drug ingredient listed Quantity of container ingredients Adequate information for use (Rx drugs only) name or location of manufacturer (packer or distributor) Words, statements, information as required by law conspicuously and prominently displayed
A label is considered to be misbranded if missing:
adequate directions for use as long as they contain the Rx legend
According to the Durham-Humphrey Amendment of 1951 labels for prescription drugs do not need to contain:
Drug Quality and Security Act of 2014 (DQSA)
Amends the FDCA regarding compounding for humans and the drug supply chain security, and provides oversight over human compounding by implementing track and trace requirements that are required for manufacturers, repackagers, wholesale distributors, and compounding pharmacies producing sterile compounded products
Drug
Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals by affecting the structure or any function of the body
Cosmetic
Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance and articles intended for use as a component of such articles, but not including soap
The Great American Fraud
Articles on the Nostrum Evil and Quacks, a series of articles in Collier's magazine by Samuel Hopkins Adams exposing the dangers of patent medicines
The Dietary Supplement Health and Education Act of 1994 (DSHEA)
Created a category for dietary supplements and specifies FDA's authority to regulate them as a special type of food instead of a drug
21st Century CURES Act 2016
Created procedures to incorporate patient experiences and "real world evidence" in drug development and regulatory decision making, and created the Breakthrough Devices program, designed to speed the review of certain innovative medical devices
No, only safety
Did the FDCA of 1938 require proof of safety and efficacy?
Yes
Did the Kefauver-Harris Amendment of 1962 require proof of safety and efficacy?
No
Did the Pure Food and drug Act of 1906 require proof of safety and efficacy?
No, only morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilid was required
Did the pure food and drug act of 1906 require companies to disclose ingredients?
No
Did the pure food and drug act of 1906 require companies to substantiate claims?
prevented false or misleading label claims of therapeutic effectiveness
In 1912, the Sherley Amendment to the Pure Food and Drug Act was passed which:
reversible containers (child-resistant on one side and not child-resistant on the other) as long as they are dispensed in child-resistant mode
In regard to child resistant containers, pharmacists may dispense drugs in:
Device
Instrument, apparatus, implant, in vitro reagent, or other similar or related article, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its primary intended purposes through chemical action within or on the body.
Hatch-Waxman Amendment
Intent of law to make generic drugs more readily available to the public and provide incentives for the manufacturer to develop new drugs, and streamlined the generic drug approval process by requiring submission of only an abbreviated new drug application (ANDA) instead of the entire new drug application
The manufacturer must submit a petition with information and evidence supporting their claim in order for the FDA to authorize a health claim on a food or dietary supplement
Per The Nutrition Labeling and Education Act of 1990 what must a company do in order to make health claims on their label?
brought awareness and prompted Congress to act on the need for oversight and standards
Publications by muckraker journalists:
Food
Raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum
dietary supplements
The FDA is prohibited from regulating _______ ___________ as food additives which require premarketing approval as well
authority for factory inspections and enforcement
The FDCA of 1938 provided:
Muckraker journalism
The Great American Fraud and The Jungle are examples of:
Grassroots Movement
The Pure Food Movement was a:
Kefauver-Harris Amendment of 1962
What amendment was passed as a result of the thalidomide tragedy?
•Statements that the product will benefit a classical nutrient deficiency disease as long as it also discloses the prevalence of the disease in the United States •Statements that describe the role of the dietary supplement in affecting the structure or function of the body •Statements that characterize the documented mechanism by which a nutrient or dietary supplement acts to maintain structure or function •Statements describing the general well-being from consumption of a nutrient or dietary ingredient (e.g. energizer, relaxant, muscle enhancement)
What are the Four Types of Nutritional Support Statements DSHEA Allows Dietary Supplement Manufacturers to Make?
•A "Drug Facts" panel containing the following information in the following order: -Active ingredients (including dosage unit and quantity per dosage unit -Purpose (general pharmacological category or principal intended action) -Use(s) (indications) -Warnings •"For external use only" for topical products; "For rectal (or vaginal) use only" for products intended for these uses •Do not use... (listing of all contraindications) •Ask a doctor before use if you have... (listing of all conditions and situations when the product should not be used) •Ask a doctor or pharmacist before use if you are... (listing of all drug-drug and drug-food interactions) • When using this product... (listing of possible side effects and substances or activities to avoid) •Stop use and ask a doctor if... (listing of signs of toxicity and other reactions requiring immediate discontinuation) •"If pregnant or breast feeding" warning •"Keep out of reach of children" and accidental overdose/ingestion warning -Directions -Other information (as required by monograph, by regulation, or in the approved labeling) -Inactive ingredients (listed in alphabetical order) -Questions or Comments... (followed by a phone number)
What are the labeling requirements for OTC?
-First segment assigned by the FDA: identifies manufacturer or distributor -Second segment identifies strength, dosage form and formulation -Third segment is package size
What are the segments of an NDC number?
Reauthorized PDUFA and added provisions to reduce and detect drug shortages, and to reduce drug counterfeiting and block imported adulterated products. It also allowed the FDA to inspect foreign drug manufacturers regulatory and requires the agency to target problematic manufacturing sites in and outside of the United States
What did FDA Safety and Innovation Act of 2012 (FDASIA) do?
created 2 classes of drugs: Prescription (safe use not possible without medical supervision) Over-The-Counter, and established the Rx legend that was required to be on prescription medications: "Caution: Federal law prohibits dispensing without a prescription", Created oral prescriptions and authorized refills of prescription drugs, and established standards for information required on prescription labels and labeling
What did the Durham-Humphrey Amendment of 1951 state?
Reauthorized drug & device provisions, and provided FDA with funding and more authority over drug safety. allowing the FDA to: Mandate labeling changes related to safety, Require clinical trial data reporting to registries, Require postmarket clinical studies to assess risks, Require companies to implement risk evaluation and mitigation strategies when necessary (REMS)
What did the Food and Drug Administration Amendments Act of 2007 (FDAAA)
Drugs had to be proved not only safe, but also effective, Established Good Manufacturing Practices requirements, and required informed consent of research subjects and reporting of adverse drug reactions
What did the Kefauver-Harris Amendment of 1962 state?
attempted to prohibit the adulteration and misbranding of foods and drugs in interstate commerce
What did the Pure Food and Drug Act of 1906 attempt to do?
The Food, Drug, and Cosmetic Act of 1938
What did the sulfanilamide tragedy lead to the passage of?
Requires use of child-resistant containers for packaging most OTC drugs and nearly all prescription drugs with some exceptions, and containers must be manufactured such that 80 percent of children less than 5 years of age cannot open them, but 90 percent of adults can
What does the 1970 Poison Prevention Packaging Act state?
FDA cannot require premarket approval for dietary supplements (drugs require premarket approval). The manufacturer is responsible to determine if a product is safe and if its claims are substantiated by adequate evidence
What does the Dietary Supplement Health and Education Act of 1994 (DSHEA) state?
food, medications, devices, and cosmetics
What does the FDCA of 1938 apply to?
no new drugs can be marketed until proven safe for use under the conditions described on the label and approved by the FDA, and expanded definitions of misbranding and adulteration, stating that labels must contain adequate directions for use and warnings for habit-forming properties of specific
What does the FDCA of 1938 state?
means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
What does the term label mean under the FDCA?
means 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.
What does the term labeling mean under the FDCA?
drugs marketed before 1938
What drugs were exempt of the FDCA of 1938?
Carl Durham and Hubert Humphrey both of which were pharmacists
Who made the durham humphrey amendment?
misbranded
a drug is _________ if there is a problem outside of the drug (i.e. on the label or labeling or with other information that should accompany the drug)
adulterated
a drug is _____________ if there is a problem with the inside of the drug (i.e. ingredients, how it was made, concentration, meets quality, safety, and compendium standards for manufacture, whether it is still in date or expired
FDAMA
act that replaces the federal legend with "Rx Only"; eliminates the provision that certain substances must be labeled "Warning - may be habit forming"
USP, the national formulary and the homeopathic pharmacopoeia
are considered official compendium
Grassroots Movement
are engaged in by people in society at a local level rather than at the center or the leadership level of the political party or organization; ordinary citizens engaging in political activities
Biosimilar User Fee Act (BsUFA) 2017
authorizes FDA to assess and collect fees for biosimilar biological products from October 2017 through September 2022
The Pure Food Movement
began in the 1870s and provided political support for the passage of the Pure Food and Drug Act of 1906
CARES Act: Over-The-Counter Monograph Drug User Fee Program (OMUFA)2020
includes statutory provisions that reform and modernize the way OTC monograph drugs are regulated in the United States and created a user fee program for OTC Drug Monographs.
Labeling
includes the LABEL that is on the container as well as any other printed material on the drug, its container, or the wrapping or any printed materials that come with the drug and its packaging.
Current Good Manufacturing Practice (CGMP)
is a set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing , packaging or holding of a drug product
label
is directly on the container.
Federal Food Drug and Cosmetic Act of 1938 (FDCA)
is the main body of federal food and drug law that governs today
Thalidomide
it was confirmed that the drug had caused severe birth defects in thousands of babies
Product Tampering
made it a federal offense to tamper with consumer product.
Dr. Harvey Washington Wiley
member of APHA who was the key advocate for federal food and drug law
The Orphan Drug Designation program
provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that: affect fewer than 200,000 people in the U.S. OR that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
Prescription Drug User Fee Act of 1992 (PDUFA)
requires manufacturers to pay fees for New Drug Applications (NDAs) and supplements when the FDA reviews clinical studies
Thalidomide
was a popular sedative that was sold in Europe in the 1950s. It was commonly used by pregnant women to treat morning sickness and to sedate babies
Generic Drug User Fee Act (GDUFA) 2012
was adopted to accelerate access to safe and improve the predictability of the generic drug review process.
USP
was created in 1820 to establish national drug standards
Food and Drug Administration Modernization Act of 1997 (FDAMA)
was passed to streamline regulatory procedures and expedite the availability of safe and effective drugs and devices
Patients or their prescribing physician may request the use of noncompliant containers for their prescriptions, Requests are permitted under the law to be oral, but in practice, pharmacists should obtain and keep documentation to protect themselves (Obtain the patient's signature; adhere to documentation requirements at your practice site (scanning signature, document in computer)) Patients may request a "blanket waiver" that all their prescriptions be dispensed in non resistant packaging Prescribers may not issue blanket waivers and can request a waiver only on an individual prescription and its refills
what are the exemptions from the requirement that all oral prescription drugs must be packaged in a child resistant container?
