PPLE Module 2

Nutrition Labeling and Education Act 1990

Mandates nutritional labeling on food products and authorizes health claims on product labeling as long as it is compliant with FDA

What form is used to report ADR

MedWatch

FDA doesn't approve

Medical foods, infant formulas, DS, food label/nutritional facts label, structure-function claims on DS

According to FDA, a drug that is recognized by USP and HPUS must

Meet all standards of compendia or it s misbranded/adulterated

Color Additive Amendments of 1960

Mfr must establish safety of color in drugs, food, and cosmetics. Delaney Clause

Dietary Supplement and Nonprescription Drug Consumer Protection Act

Mfr must report serious ADR

Who is responsible for notifying seller and the consumer of recall

Mfr notify seller and seller notifies consumer

Pharmacist compounds drug using standards diff form USP but the label still states USP

Misbranded and adulterated

Drug imitates another drug

Misbranding

Label fails to include mfr name and address

Misbranding

Mfr not approved by FDA

Misbranding

REMS

drug safety program FDA requires for certain drugs to ensure benefits outweighs risk. Reinforces med use behaviors that support safe use of med

Misbranding

false statements about strength, quality, and purity of drug

Imitation drugs

identical in shape, size and color, and similar or virtually identical in gross appearance, similar in effect to controlled substances

Drug

substance(s) used to cure, mitigate, or prevent disease in animals or humans

US Dep of Agriculture regulates

Egg products, meat from livestock, poultry

Conscience clauses

Enable pharmacists to refuse to dispense based on moral beliefs in some states.

How does FDA enforce the FDCA

Injunctions against violator to cease illegal activity, institute criminal action resulting in fines/imprisonment, seizure of the goods, warning letters

Drug Price Competition and Patent Term Restoration Act 1984

"Watchman-Hatch" amendments. Established path for generics via ANDA and provide incentives for mfr to develop new drugs

NDC

10 digit 3 segment code. first = mfr or distributor second = strength, formulation, and dosage form third = package size and type of drug Billing and claims have 11 digit NDC

Mfr are inspected every -- years

2

Accompanying def

Accompanies drug then labeling, otherwise advertising

Package inserts

Accompany drug that contains essential scientific info for safe and effective use of drug by HCPs

Prescription drug whose transaction statement is nonexistent, fraudulent, or incomplete; or distributed by unauthorized person

Adulteration

Labeling def

All labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers accompanying such article It includes labels, med guides, and instructions for use

DSHEA permitted claims

Benefiting classical nutrient deficiency Structure/function Characterizing MOA Statements of wellbeing Claims must be truthful and not misleading and have disclaimer that they aren't FDA approved

Poison Prevention Packaging Act

Child-resistant containers for most OTCs. 80% of children under 5 can't open it but 90% of adults can. Patient asks for non-resistant container then document it and give it to them Law allows mfr to market one size of OTC for PWD and elderly

Describe the different classes of recalls

Class 1: dangerous or defective product that could cause serious problems Class 2: temporary health problem or slight problem Class 3: unlikely to cause adverse problem but violates FDA labeling and mfr laws

Food Additives Amendment 1958

Components added to food must have premarket approval for safety Delaney Clause prohibits approval of food additive that might cause cancer

Tampering is a -- offense

Federal

FDA is housed within the ---

DHHS

DSHEA 1994

Define DS and permitted mfr to make certain claims that would have been illegal under FDCA. DSHEA forces FDA to regulate DS more as foods than drugs

Orphan Drug Act 1983

Diseases that affect < 200,000 per year. Tax advantages and exclusive licensing rights to mfr

Device Def

Doesn't achieve purpose via chemical action and is not dependent on being metabolized for principal purpose. An instrument, apparatus, implement, machine, contrivance, implant in vitro reagent recognized by USP or NF Some devices contain drug and are combo products

Federal Pure Food and Drug Act 1906

Drugs and foods can be considered interstate commerce. Can have penalties for misbranding and adulteration. Held states enact more strict food/drug standards for intrastate commerce USP and NF made official standards for definition of adulteration of drug

Durham Humphrey Amendment 1951

Established two classes of drugs: OTC and RX. Labels of RX drugs don't require adequate directions for use if they have a "caution: federal law prohibits dispensing without a prescription" label. Authorized oral prescriptions and refills as well. If dispensed by pharmacist, directions from prescriber satisfies the adequate directions for use requirement

Prescription Drug Marketing Act 1987

Establishes sales restrictions and recordkeeping for prescription drug samples. Can't resell purchases to other businesses

Park Doctrine

Establishes that corporate officers can be prosecuted without proof that they intentionally acted in negligent manner

Medical Devices Amendments of 1976

Ex. Dalkon Shield. Regulation, admin authority, and premarket approval for safety and efficacy of medical devices

Safe Medical Devices Act 1990

FDA additional authority to post-marketing surveillance for monitoring products after clearance to market. Device tracking for traceability

Generic Drug Enforcement Act 1992

FDA can ban individuals or firms from drug approval process if convicted of related felonies and imposes severe civil penalties for false statements, bribes, etc.

Drug Quality and Security Act 2013

FDA oversight over pharmacies engaged in large-scale compounding and shipping of sterile products. Added track and trace requirements for all entities. Mfr must provide transaction info to purchasers, wholesalers, and pharmacies

21st Century Cures Act 2016

FDA recruit and retain scientific, technical, and professional experts. Incorporates patient perspective in FDA decision making process

Who gives the FDA limited authority to recall certain products like devices, biological and foods but not drugs

FDAAA

FDA operates within the framework of --- legislation

FDCA

Selling recall products by pharmacists violates--

FDCA

T/F: DS require premarket approval

False

T/F: FDA does approve cosmetics

False

T/F: Primary purpose of drug labeling is to give patients info

False, it is for HCPs

Food and Drug Modernization Act 1997

Fast-track approval process (30 to 15 months) for drugs intended for serious or life-threatening disease. Data bank on clinical trials, authorizes scientific panels to review clinical investigations, expands rights of mfr to disseminate unlabeled use info. Ensures timely review of apps. Reauth of PDUFA

Adulteration def

Focus on product and facility. Pure drug is considered adulterated on the basis of conditions of facility (how it's prepared, packaged, stored, container). Drug is adulterated if its strength, quality or purity differ from label or compendia standards unless clearly stated on label Ex. Container contaminated, held in conditions that have been contaminated, mfr in non-cGMP

FDA regulates

Foods (DS, bottled water, food additives, infant formulas) Drugs (RX and OTC) Biologics (vaccines, gene therapy, blood products) Med Devices (pacemakers, surgical implants) Cosmetics (skin care, color additives) Other (vet, tobacco, electronic products)

Prescription Drug Labels

For HCP not patient with the exception of MedGuides or Patient instructions. New package inserts require highlights section, table of contents, full prescribing info, and patient counseling info

Adequate information for use

For Rx drugs

Food Def

If it is used for its ordinary purpose in ordinary matter

Explain the word "may" in adulteration law

Intended to regulate facilities rather than product because easier to inspect plants rather than do recalls from market if drug is risky

Who was Harvey Wiley?

Key person in enacting national food and drug statute and forced Congress to enact legislation

Food, Drug, Cosmetic Act 1938

No new drug could be marketed until it was proved to be safe to be used under conditions described on label and FDA approved. Applies to cosmetics and devices too. Applies to interstate commerce and transactions between pharmacists and patients. Drug marketed prior to 1938 exempt from safety before marketing

Nutraceutical/Functional foods are:

Not a legal category. Nutraceuticals are for prevention or treatment of disease like cereals, beverages Functional foods are enhanced with DS

Core functions (4) of the FDA are

Offices of Medical Products and Tobacco Foods and Vet Medicines Global Regulatory Operations and Policy Policy, Planning, Legislation, and Analysis

Pregnancy warnings

Old categories were ABCDX A = no risk to fetus but can't rule of possibility of harm B = animal studies failed to demonstrate risk to fetus C = animal studies showed risk or no animal studies done. Grey zone D = fetal risk based on human data X = fetal risk, don't give at all. New regulation has Pregnancy, Lactation, and Female/Male Repro Potential subsections

Does cGMP apply to pharmacies?

Only if they are deemed as mfr and registered as outsourcing facility

FDA commissioner is appointed by -- and confirmed by -- and accountable to --

President and Senate and Secretary of DHHS

DS Def

Product intended for ingestion, intended to supplement diet.

1912 Amendment of Pure Food and Drug Act

Prohibited false and fraudulent efficacy claims after US vs Johnson Case

Qualified vs Unqualified Claims

Qualified = must have disclaimer because didn't pass test Unqualified = passed test

FDA Safety and Innovation Act of 2012

Reauth of PDUFA Adds new user fees for generics and biosimilars. Reduce drug counterfeiting, block import of adulterated products, detect and reduce drug shortages.

FDA Amendments Act of 2007

Reauth of PDUFA and increase in fees. FDA gets more responsibility and authorization to regulate drug safety, mandate label changes related to safety, require data reporting, post-market clinical studies for risk assessment, and require companies to implement REMS

Prohibited Acts

Receipt and delivery of adulterated or misbranded drug. Doing any act that causes a drug to be counterfeit. Adulteration, mutilation, etc. of labeling

Drug Def

Recognized in USP or homeopathic pharmacopeia or national formulary. Intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease. Articles intended other than food to affect structure or function of body. Anything intended for therapeutic purpose or purpose of altering structure/function of body.

Misbranding def

Representations made by mfr on label or labeling. Labeling cannot be misleading or false. Labeling must include a list of active, quantity, inactive in alpha order. Labeling must have adequate directions for use by children and others who may use it. Prescription drugs exempt from adequate directions of use if they contain adequate information for use.

Kefauver-Harris Amendment 1962

Required drugs to be proved safe AND effective. Effective requirement retroactive for all drugs marketed between 1938-1962. Called for more extensive controls for clinical investigations and reported of ADR. Established cGMP Jurisdiction of Prescription drug advertising transferred to FDA from FTC. Ex. Thalidomide

Black Box Warnings

Required in labeling when drug use may lead to death or serious injury. FDA approved with restrictions to ensure safe use REMS

Prescription Drug Use Fee Act 1992

Required private industry to shoulder part of costs for FDA to review clinical studies for new drugs to speed up NDA reviews. Must be reauthorized every 5 years

FDA Reauthorization Act of 2017

Revise and extend user-fee programs for biosimilars, drugs, generics, devices.

Functions of FDA

Rulemaking via regulations that is done by notice and comment rulemaking that allows for public input before FDA issues final regulation

Durham-Humphrey Amendment of 1951

Rx drugs are unsafe unless under PCP, subject to NDA approval process, and to go from OTC to Rx must show toxicity and method of use requires PCP

Ways to switch from Rx to OTC

SNDA Citizen petition through FDA Amend OTC monograph

cGMP

Set of regulations or standards that mfr must follow to ensure drug is safe and meets purity guidelines. If don't follow cGMP then adulteration occurs

Official Compendia

Sets uniform standards. USPC works with FDA but is a private org

BUD

Should be on label and not be longer than mfr date or 1 year whichever is earlier.

Legal Categories of Food

Special dietary foods are regulated under FDCA and include but not limited to those that supply dietary need due to pathological, physical, or other condition. Condition includes pregnancy, lactation, under/overweight, hypersensitivity, infancy. Ex. Ensure, caloric supplements. Medical Foods are those taken orally or for enteral nutrition under PCP for dietary management of disease. Ex. Osmolite or Jevity which are specially formulated.

Health Claims on Foods

Supplements are not meant to treat, cure, prevent, or diagnose diseases. Nutrition Labeling and Education act states that foods that contain health claims have to be approved by FDA or pass sig scientific agreement test

Elixir Sulfanilamide

Tragedy pointed out the inadequacies of Pure Food and Drug Act. Product contained antifreeze and product wasn't tested for safety. FDA charged them with misbranding because marketed as elixir. The FDA didn't have authority to remove drug for any other reason than misbranding purposes under the current law

FDA can only take action against DS that is misbranded or adulterated after it reaches market

True

T/F: Corporate officers can be convicted even if other employees violate FDCA and they were unaware

True

T/F: FDA issues guidance documents that are less formal and not legally binding

True

T/F: FDA regulations are federal laws but not part of FDCA

True

T/F: FDCA prohibits refusal to permit access to or copying of any record as required and failure to establish or maintain any record; refuses permit of entry and inspection

True

T/F: Health claims must be FDA approved or pass sig scientific agreement test

True

T/F: If label states that the strength or purity of drug is different then there is no adulteration

True

T/F: It is per mfr discretion to put warnings about habit-forming substances

True

T/F: Non-human use drugs don't need quantity, active ingredients and inactive

True

T/F: Pharmacists who relabel package must follow labeling requirements by mfr

True

T/F: Professional labeling can be published by mfr for conditions not appropriate for lay diagnosis or treatment

True

OTC labeling

User friendly format with pharmacologic category, principle intended use, cautions, warnings, adequate directions for use, and Drug facts panel

What is a recall

Voluntary action taken by mfr to remove product from market. Can occur by FDA request or via company. Done by First class mail with clear markings on envelope.

Cosmetic becomes a drug

When seller makes health or structure/function claim

Mudrakers

Wrote exposes on shocking conditions in food processing and dangerous ingredients and fraudulent advertising of drugs

Can a pharmacist claim good faith if they violated FDCA unknowingly and are willing to help with investigation

Yes

Can you have a product that is drug and cosmetic

Yes ex. antidandruff shampoo

Drug or device is past expiration date

adulteration

Drug returned by a vet to a limited prescription drug vet wholesaler distributor

adulteration

Failure to mfr product in tamper resistant container is

adulteration and misbranding

Evidence a Product is Drug

labeling claims, advertising, nature of product or consumer perception

Adequate directions for use

layperson can use drug safely, for OTCs

FDA selects drugs based on --- for mfr inspections

market share, previous compliance records, medical importance

If one mfr switches from Rx to OTC does this apply to all mfr of similar or same product

no

HPUS

standards for homeopathic products. These don't have FDA approval

Combination products

therapeutic and diagnostic products that combine drugs, devices, and/or biological products

What is the FDA's role in recall

to oversee a company's strategy, assess the adequacy of the recall and classify the recall

Cosmetic

topical articles intended for cleansing, beautifying, or altering appearance

Does switching the monographs apply to all mfr products at same time

yes