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