Law Chapter 2

define 'new drug'

-a drug that is not generally recognized by qualified experts as safe and effective (GRASE) for use under the conditions recommended in the drug's labeling; and have been used for a material extent and time for conditions recommended in labeling -FDA will not accept a GRASE application and requires a NDA

Class II FDA recall

-occur when product may cause temporary or medically reversible adverse health consequences, but probability of serious adverse consequences is remote

Medwatch statement must be on each new and refill prescription via any of the following means:

-on a sticker attached to the container or package -on a preprinted vial cap -on a separate sheet of paper -in patient medication information distributed by the pharmacy -in a MedGuide

When can the FDA remove a dietary supplement from the market?

-on the basis that the product is adulterated, defined as presenting significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the label -ex: ephedrine alkaloid

Pregnancy Category D

-positive evidence of fetal risk exists based upon data from investigational or marketing experience or studies in humans; however, potential benefits from the drug may be acceptable despite potential risks (e.g., in life-threatening or serious disease situations for which a safer drug cannot be used). A statement must be included in the Warnings and Precautions section that the drug can cause fetal harm, and that the patient should be apprised of the risk if pregnant

Phase 4 clinical trials

-postmarketing surveillance sorta -required when adverse event reporting or active surveillance is inadequate -gave FDA authority for 'fast-track' drug approval

Reasons for unapproved drugs to be on the market

-pre-1938 drugs -FDA has yet to remove some drugs lacking efficacy after DESI -lax FDA policies applied to generic approvals prior to 1984 -unscrupulous manufacturers -some drug manufacturers simply market their product without approval hoping they will get away with it

Define biologics

-products derived from living organism: --viruses --therapeutic serums --toxins --antitoxins --vaccines --blood and blood components --derivatives applicable to prevention, tx, or cure of disease -Licensure by Public Health Service Act (PHSA) but subject to FDCA and FDA requirements

Pure Food and Drug Act 1906

-prohibited the adulteration and misbranding of foods and drugs in interstate commerce -did NOT prevent misbranding efficacy claims -did NOT give authority to FDA to ban unsafe drugs (technically FDA wasn't formed as an agency until 1930)

OTC category I

-includes ingredients generally recognized as safe, effective, and not misbranded

What does the office of medical products and tobacco oversee at the FDA?

*-Center for Drug Evaluation and Research (CDER)* *-Center of Biologics Evaluation and Research (CBER)* -Center for Devices and Radiological Health -center for tobacco products -office of Special Medical Programs -Office of Combination Products -Office of Good Clinical Practice -Office of Pediatric Therapeutics -Office of Orphan Products and Development

OTC category II

-includes ingredients that are not generally recognized as safe and effective or that are misbranded

Phase 2 clinical trials

-initial trials with humans who have the specific disease sought to be treated or controlled

What subheadings in Warnings are required in nonprescription drug labeling requirements

-'for external use only' for topical products -'for rectal (or vaginal) use only for products intended for those uses -do not use (list of 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 drug-drug and drug-food interactions) -when using this product (list 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 breastfeeding' warning -'keep out of reach of children' and accidental overdose/ingestion warning

What is included in a national drug code number (NDC) and what information does that give us?

-11-digit three segment code -first segment identifies manufacturer or distributor (the first 5 digits section) -the second segment identifies strength, dosage form, and formulation (middle 4 digits section) -the third segment indicates package size and type of drug (last 2 digits) -just because a drug has an NDC does not mean it has been approved by FDA

OTC drug review

-1962 efficacy requirement in Kefauver-Harris also became required for OTC drugs -review process approves drugs on the basis therapeutic category rather than individual drugs -*classifies products through rule-making rather than on a case-by-case basis* -FDA appoints advisory review panels of experts to consider drugs by class, and make recommendations -FDA publishes panel recommendations in Federal Register -after notice and comment, FDA publishes a proposed rule in Federal Register -then agency publishes a monograph, which also specifies labeling -new drugs conforming to monograph may be marketed without FDA approval

Food, Drug, and Cosmetic Act 1938

-21 U.S.C section 301 et seq. -no new drug could be marketed until proved safe for use under condition described on the label and approved by FDA -also expanded definitions of misbranding and adulteration--required labels must contain adequate directions for use and warnings about habit-forming properties -applies to drugs, cosmetics, and devices

Health Care and Education Reconciliation Act of 2010

-Amendment to the ACA

Functions of the FDA include:

-Rulemaking (section 707 of FDCA) -issue guidance documents -incorporate advice from standing advisory committees of outside experts (members of expert panels are recruited in the Federal Register)

Drug Quality and Security Act of 2013

-DQSA -made sure that compounding is correct -result of contamination of vials in New England and dead polo ponies

Approval process of NDA

-FDA has 180 days to act on a completed NDA, but delays are common -approval based on proof of safety and efficacy, the manufacturing process, and benefit/risk ratio -applicant may judicially appeal a reject NDA but success if very unlikely

Purpose of a 'paper' NDA

-FDA lacked authority to allow ANDAs for post 1962 generics, so created the 'paper NDA' in the 1970s. -under this route, a generic drug manufacturer would not have to duplicate actual research establishing safety and efficacy of innovator drug, using data from innovators' studies -was not very effective--seldom enough published literatur to support manufacturer's claims of safety and efficacy for the drug

Drug advertising and promotion regulation

-FDA regulates Rx drug advertising -FTC regulates OTC drug advertising -first amendment restricts government regulation of commercial advertising and any regulation will be evaluated pursuant to the four factors established by the US Supreme court

Orange Book

-FDA's book on therapeutic equivalence evaluations

Patient treatment with investigation drugs

-FDAMA modified the FDCA to state than an investigation drug may be provided for widespread access outside controlled clinical trials to treat patients with serious or immediately life-threatening diseases for which no comparable or satisfactory alternative therapy is available.

Why is postmarketing surveillance necessary?

-IND is only tested in a small number of patients -long term adverse effects may not be discoverable before approval

What 4 offices in the FDA report to the Commissioner's office?

-Office of Foods and Veterinary Medicine -Office of Global Regulatory Operations and Policy -Office of Medical Products and Tobacco -Office of Operations

Define counterfeit drug

-a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor

Tamper resistant packaging

-a package 'having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occured'

Define dietary supplement

-a vitamin, mineral, herb or other botanical, amino acid, or substance used to supplement the diet by increasing total dietary intake

Define tampering

-act as improper interference with the product for the purpose of making objectionable or unauthorized changes

The Patient Protection and Affordable Care Act 2010

-added health care law -added provisions to the FDCA and directly and indirectly affected other law related to pharmacy practice

When can an approved drug become a new drug?

-addition of new substance (e.g. active ingredient, excipient, carrier, coating) -new combination of approved drugs -change in proportion of ingredients -new intended use -the dosage, method, or duration of administration or application is changed

Corporate Officer Liability

-affirmative duty of corporate officers to be aware of and correct violations -PARK doctrine: establishes that corporate officials can be personally prosecuted without proof they acted intentionally or with negligence and even if they had no knowledge of offense

Is tobacco a drug?

-after a lot of court battles, Congress enacted legislation in June 2009 called the Family Smoking Prevention and Tobacco Act, granting FDA authority to regulate tobacco -FDA introduced regulations in April 2014 that would ban e-cigarettes to <18 year olds

Kefauver-Harris Amendment 1962

-aka Drug efficacy amendment -requires drugs to be safe and effective -made retroactive to all drugs marketed between 1938 and 1962 -transferred jurisdiction of prescription drug advertising from the FTC to FDA -established good manufacturing practices (GMP) requirements -added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting adverse drug reactions

Food and Drug Administration Modernization Act 1997

-aka FDAMA -hoped to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices -required compliance plan -increased FDA public accountability -also creates fast-track approval process for drugs intended for serious or life-threatening diseases -expanded FDA authority over OTC drugs

The FDA Safety and Innovation Act of 2012

-aka FDASIA -reinstate PDUFA -added user fees for generic drugs and biosimilars -also tried to reduce drug counterfeiting

Prescription Drug User Fee Act 1992

-aka PDUFA -requires drug manufacturers seeking NDAs to pay fees for applications and supplements when the FDA must review clinical studies -the fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and hopefully speed up the NDA reviews -must be reauthorized every 5 years

Drug Price Competition Act 1984

-aka Waxman-Hatch Amendment -streamlines the generic approval process while giving patent extensions in certain cases to innovator drugs -statutorily created the abbreviated new drug application (ANDA), expediting generic approval

Biologics Price Competition and Innovation Act (BPCIA) of 2010

-allows biosimilars or follow on biologics -allows FDA authority to determine whether a biosimilar is 'therapeutically equivalent' to a reference biologic -state of Indiana biosimilar substitution law in 2014 (SB262)

Pregnancy Category B

-animal studies have failed to demonstrate a risk to the fetus and there are no adequate well-controlled studies in pregnant women. As with Category A, a statement must be included providing that the drug should be used during pregnancy 'only if clearly needed'

Class III FDA recall

-applies to products that are not likely to cause adverse health consequences

Dietary Supplement Health and Education Act 1994

-balanced out authority of FDA -created less regulations on dietary supplements -supplements are treated more like food than like drugs

Generic Drug enforcement Act 1992

-bans individuals or firms from participating in the drug approval process if convicted of related felonies -imposes severe civil penalties for any false statements, bribes, failures to disclose material facts, and other related offenses

Controversies related to the PTRA

-bioequivalence of generics to the parent and each other -whether a drug without market exclusivity for a particular indication could be prescribed and dispensed for that indication -whether FDA can approve an ANDA for a generic when labeling will not include one or more of the indications contained on the innovator drug product's labeling -'authorized generics' (innovator manufacturer producing a generic version of their own product, i.e. Adderall) -'pay for delay' (company pays generic manufacturer to delay the marketing of their product)

Medicare Prescription Drug, Improvement, and Modernization Act of 2003

-brought about Medicare Part D and MTM

Food Additives Amendment 1958

-components added to food products must receive premarket approval for safety -also contains anti-cancer provision (aka Delaney clause)

HEA 1065--Use of Drugs for Terminally Ill- the 'Right to Try Act' - Indiana State Law 2015

-includes drugs, biologicals, or medical devices -patients with terminal disease (according to physician) who considered all other approved treatments would be allowed to try 'experimental' treatments out of Phase I trials -probably risk to patient with treatment not greater than risk of disease/condition -no causes of action against manufacturers or health care providers involved with investigation treatment, drug, biologic, or device

3 designations giving for drugs going through FDA approval process

-determines how quickly drug will move through approval process -S = standard review -P = priority review-for 3 reasons: 1. no other effective drug is available 2. more effective or safe than drugs currently used 3. it has important advantages -O = orphan drug

Define adulteration

-drug is filthy, putrid, decomposed -drug is prepared, packed, or held in unsanitary conditions and may have been contaminated -if made but not in conformance with cGMPs -drug container is composed of poisonous, deleterious substance -contains or is an unsafe coloring agent -drug or device does not meet standards set of that class or device -if its strength differs from or its quality and or purity falls below the labeled representation -if it is mixed or packed in such a way that quality or strength is reduced -if it substituted in whole or in part - that is totally a different drug -generally: something is wrong with the inside of the Rx vial

Pregnancy Category C

-either animal studies have shown an adverse effect on the fetus or there are no animal reproductive studies, and there are no adequate well-controlled studies in pregnant women. A statement must be included that the drug should be used during pregnancy 'only if the potential benefit justifies the potential risk to the fetus'

Unit dose labeling requirements

-established name of drug -quantity of AI -expiration date -lot or control number -name or place of manf -any statements required by a compendia if an official drug

Prescription Drug Marketing Act 1987

-establishes sales restrictions and recordkeeping requirements for prescription drug samples -prohibits hospitals and other health care entities from reselling their pharmaceutical purchases to other businesses and requires the state licensing of drug wholesalers

Fast track approval (506)

-expedited review possible for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs for the condition; and that the drug has an effect on a clinical endpoint predictive of clinical efficacy -conditional on manufacturer agreeing to phase 4 testing

What is include in 'bioequivalence establishment'?

-extent of absorption (max concentration, Cmax) and -rate of absorption (AUC) -both parameters can vary by +/- 20% with 80% certainty

Medical foods

-foods formulated for oral use under the supervision of a physician and that are intended for specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation -ex: foods formulated without phenylalanine; combo products of folic acid, B6, and B12

Some requirements in a NDA

-full reports of investigations showing the drug's safety and efficacy -the drug's components and composition -the methods, facilities, and controls used in manufacturing, processing, and packaging the drug -samples of the drug and its components -the proposed labeling of the drug

Class II medical devices:

-general controls alone are insufficient to ensure safety or efficacy. -performance standards must be met -includes insulin syringes, infusion pumps, thermometers, tampons, electric heating pads

Supplemental New Drug applications

-generally required when a manufacturer makes any change in an approved drug or in its production 3 categories: 1. production/manufacturing 2. 'change being effected (CBE)' - strengthened warnings or dosage and administration 3. small/minor changes -a change being effects SNDA allows the sponsor to make the change before FDA approval and is important for labeling changes

Purple book

-has list of biosimilars (similar to orange book for small molecule drugs)

What are some restrictions regarding the display of dietary supplement publications?

-has to be reprinted in their entirety -not false or misleading -presented with other publications for a balanced view -physically separate from actual product -do not attach to product with stickers

General Info on FDA

-housed under Department of Health and Human Services -Authority for administering the FDCA via the Secretary of DHHS -FDA commissioner is appointed by President with confirmation of Senate -Commissioner of FDA is still accountable to the Secretary of DDHS

Purposes of IND

-human safety -proper clinical trial design

Physician Payment Sunshine Act

-included in the Affordable Care Act -CMS enacted regulations in 2013 -mandated disclosure by drug and device mfs and group purchasing orgs to DHSS of nontrivial payments to physicians and teaching hospitals -must register every 'drug pen' received by drug companies

OTC category III

-includes ingredients for which available data are insufficient to permit classification -drugs not studied start in this category

Drug efficacy study implementation (DESI) - 1968

-initiated to evaluate the efficacy of drugs approved between 1938 and 1962 in response to 1962 Kefauver amendment that drugs need to be safe and effective -FDA required retroactively drugs marketed after 1938 to proving efficacy -created the abbreviated new drug application (ANDA) for generic drugs approved between 1938 and 1962

Phase 1 clinical trials

-intro of drug into healthy humans in small amounts to determine mainly adverse effects and: --toxicity --dose ranges --human metabolism --ADME

Class I FDA recall

-issued when there is reasonable probability that the product will cause serious adverse health consequences or death

Rx label requirements

-labeled for health care profession, NOT patient -name and address of manf -established name of drug product -ingredient info including quantity and proportion of each AI -names of inactive ingredients if not for oral use -a statement of identity -quantity in terms of weight or measure -net quantity -state of recommended or usual dosage -symbol of Rx only or legend -route of admin if not for oral use -identifying lot or control number -a statement directed to pharmacist specifying type of container needed -expiration date

Misbranding definition

-labeling of the drug or device is false or misleading in any way -does not conform to labeling requirements -contains narcotics or hypnotics and label does not contain 'warning-may be habit forming' -generally: something is wrong with the outside of the Rx vial--something is wrong with the label or labeling

Phase 3 clinical trials

-large scale, multi-center safety and efficacy studies in patients with the disease sough to be treated or controlled (NDA filed after this phase)

Class I medical device:

-least regulation -least harm -includes needles, scissors, examination gloves, stethoscopes, and toothbrushes

FDASIA of 2012

-mandated FDA to issue guidance on promotion of Rx Drugs and devices through social media by July 2014. -FDA created 3 draft guidance documents: --Jan 2014--interactive promotional media --June 2014--guidance in SM on space limits --June 2014--guidance on how mfrs should respond to correct 3rd party misinformation about their products on the internet through social media

Nutrition Labeling and Education Act 1990

-mandates nutrition labels of food products -allows foods to contain health claims if approved by FDA by regulation or by the 'significant scientific agreement' test (also part of FDAMA) -manufacturer must submit considerable evidence to support the claim to obtain FDA approval

Risk Evaluation and Mitigation Strategy (REMS)

-may require as a condition for approval of an NDA or postmarket when the FDA believes it necessary to ensure benefits outweigh risks -FDA can require a variety of procedures ranging from Medication Guides to limiting the drug to specified settings for dispensing

Package insert requirements

-must be with the drug product and contains essential and medical information needed for safe and effective use of the drug -newer requirements include a 'highlights' section at the beginning, a table of contents, 'Full Prescribing Information' organized to give prominence to most important info, and a 'patient counseling info'

Class III medical devices

-must have premarket approval -life-supporting -includes pacemakers, soft contact lenses, replacement heart valves -any devices not marketed before 1976 initially fall into this class unless FDA determines that they are substantially equivalent to another class

What is required in an IND

-name of drug -composition -methods of manufacture and quality control -info from preclinical (animal) investigations regarding pharmacology, PK, and toxicology evaluations -info on investigators -clinical trial plan

Phase 0 clinical trials

-newer phase--biomarker/minute dose studies in humans

How are cosmetics regulated?

-no premarket approval (except for color additives), nor conformance with cGMP, although manufacturers must substantiate safety of each ingredient -FDA may remove if misbranded, adulterated, or a health hazard -must be labeled with list of ingredients in descending order of predominance and appropriated warnings

Direct-to-consumer advertising regulations

-no specific laws and regulations for DTC thus 502n applies -FDA allows manufacturers to apply the 'adequate provision' requirement, provided the consumer is offered full labeling information from one or all of four sources -for DTC print ads, FDA encourages manufacturers to present key risk info in user friendly ways -FDAA has provided FDA with authority to require pre-review of ads -GAO report noted FDA weaknesses in regulating DTC ads

Federal Anti-Tampering Act

-now a federal offense to tamper with consumer products

Lanham Trademark Act

-prohibits the use of any false description or representation -written in response to American Home Products vs J&J 654 F. Supp. 568 (SDNY 1987)--makers of Advil and Tylenol sued each other for false advertising claims -allows for private cause of action and recovery of monetary damages

Medical Device Amendments 1976

-prompted by public safety concerns about the Dalkon Shield (an IUD), Congress amended FDCA -provides for extensive regulation regarding safety and efficacy of medical devices -classifies devices according to function -requires premarket approval -established performance standards -conformance with GMP regs -adherence to record and report requirements -definition of device excludes articles that achieve their purpose through chemical action and metabolism

Rationale for Federal Drug Regulation

-protection of the public against adulterated and misbranded drug products -necessity of balancing 'direct regulation' and 'indirect regulation'

Orphan Drug Act 1983

-provides tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of 'rare diseases or conditions'

Food and Drug administration Amendments Act 2007

-reauthorized old laws that were going to expire -allowed FDA to mandate labeling changes related to safety; require clinical trial data reporting and registries; require postmarket clinical studies to assess risk; and require companies to implement risk evaluation and mitigation strategies (REMS) when necessary -also gave FDA authority to require manufacturers to add safety info or warnings postmarket

Durham-Humphrey Amendment 1951

-required all drugs to be labeled with 'adequate directions for use' -established two classes of drugs: prescription and over-the-counter

Black Box Warnings

-required in labeling when use of a drug may lead to death or serious injury -required for about 450 prescription drugs

Informed consent

-required in writing for phase 1 and 2 -only oral consent is needed for phase 3 (but written in patient's medical record) or in writing -research subjects required to know risks, possible benefits and alternative courses of treatment -IRB approval required in most settings.

Color Additive Amendment 1960

-required manufacturers to establish the safety of color additives in foods, drugs, and cosmetics

Postmarketing surveillance

-required of manufacturer after NDA approval -must submit to FDA reports of serious adverse drug reactions and any new information of safety and efficacy

What is required in an ANDA?

-requires evidence of bioequivalency and manufacturing methods rather than proof of safety and efficacy

manufacturer to professionals prescription drug advertising regulations

-section 502(n) requires all ads to contain 'true statement' and 'brief summary' -reminder advertising is exempt -true statement not met if ad is false or misleading, does not present a fair balance and fails to reveal material facts -advertising includes ads in journals and other periodicals, broadcast media, and telephone communications -brochures, booklets, mailings, bulletins, calendars, and other information distributed to health care professionals by a manufacturer is labeling

cGMPs

-set of regulations that establish minimum requirements for the methods, facilities, or controls used in the manufacture processing, packaging, or holding of a drug product -manufacturers must register with FDA and are usually inspected by FDA for compliance with cGMP every 2 years

Section 505(b)(2) NDAs

-similar to extinct 'paper NDA' -used to file for new indications for approved drugs and to file for generic approvals that do not qualify under an ANDA -Ex: if a formulation or route of admin or delivery mechanism for a generic product changes significantly

Nonprescription drug labeling requirements

-statement of ID of product -name and address of manf -net quantity of package -cautions and warnings -adequate directions for use -a 'drug facts' panel including: --active ingredient --purpose --use --warnings --directions --other info --inactive ingredients --questions

Safe Medical Devices Act 1990

-strengthened the Medical Devices Amendment Act of 1976, giving FDA additional authority especially related to postmarketing requirements premarket notification and approval

Pregnancy Category X

-studies in animals or humans have demonstrated fetal risk, and that risk in pregnant women clearly outweighs any benefit. The Contraindications section must state that the drug 'may cause fetal harm when administered to a pregnant woman.' A statement must also be included that the patient should be apprised of the potential hazard to the fetus if used while pregnant.

Special dietary foods

-supply a special dietary need that exists by reason of a physical, physiological, pathological, or other condition -ex: infant formulas -artificial sweetners -caloric supplements

What gives congress the power to regulate interstate commerce?

-the commerce clause

MedWatch

-voluntary reporting system to allow health care professionals to report any serious adverse events, product use errors, and product quality issues -FDAAA requires pharmacies to provide patients with the MedWatch number and a statement about reporting side effects

Define cosmetic

1) 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 2) articles intended for use as a component of any such articles; except that such term shall not include soap

Define food

1. Articles used for food or drink for man or other animals 2. Chewing gum 3. Articles used for components of any such article

What are the five centers of the FDA?

1. Center for Biologics Evaluation and Research (CBER) 2. Center for Food Safety and Applied Nutrition 3. Center for Drug Evaluation and Research (CDER) 4. Center for Veterinary Medicine 5. Center for Devices and Radiological Health

Identify the significant historical events that have shaped the current federal FDCA (3 major ones included in lecture)

1. FDA formed as agency in 1930 2. Sulfanilamide elixir tragedy in 1937--diethylene glycol was used as a solvent and resulted in 107 death. 3. Passing of the Food, Drug, and Cosmetic Act (1938)

The four factor established by the US Supreme court to regulate commercial speech (advertising and promotion)

1. The speech must not be misleading or related to an unlawful activity 2. The government interest in the regulation must be substantial 3. The regulation must directly advance the government interest asserted 4. the restriction of speech cannot be more extensive than necessary to serve that interest

FDA will approve the investigation drug for treatment only if:

1. It is to be used for a serious or immediately life-threatening disease or condition 2. there is no comparable or satisfactory alternative therapy available 3. the drug is under investigation for the disease or condition 4. the sponsor is actively pursing marketing approval of the drug 5. in the case of serious diseases, there is sufficient evidence of safety and effectiveness for the use 6. in the case of immediately life-threatening diseases, there is a reasonable basis to conclude that the drug may be effective and would not expose patients to unreasonable and significant risk

Claims dietary supplement suppliers are allowed to make under DSHEA

1. benefiting a classical nutrient deficiency disease 2. describing the role of the DS in affecting the structure/function of the body 3. Characterizing the mechanism by which a DS act to maintain the structure or function 4. statements of general well-being -cannot be false or misleading

FDA prioritizes illegally marketed drug removal by

1. drugs that present safety risks 2. drugs that lack evidence of efficacy 3. drugs that involve health fraud

10 chemical types for FDA classifications

1. new molecular entity 2. new active ingredient 3. new dosage form 4. new combination of compounds 5. new formulation or new manufacturer 6. new indication (drug product previously marketed by same firm) 7. drug already marketed without an approved NDA 8. OTC switch 9. New indication submitted as distinct NDA, consolidated with original NDA after approval 10. New indication submitted as distinct DNA, not consolidated

ID the situations that may cause a drug to be adulterated or misbranded

Adulteration: -sneezing on a counting tray -product tampering Misbranding: -false or misleading labeling

4 different types of patent certification for a generic applicant relative to the reference or innovator drug

1. that the NDA holder did not file information on the patent to the FDA 2. that the patent already had expired 3. the date that the patent will expire 4. that the patent is invalid or will not be infringed by the manufacture, use, or sale of generic applicant's drug

New pregnancy and lactation warnings

8.1 Pregnancy: includes Labor and Delivery 8.2 Lactation: includes Nursing Mothers 8.3: Females and Males of Reproductive Potential

Recognize the prohibited acts, penalties and enforcement mechanisms in the FDCA

Adulteration and misbranding. Strict liability Can lead to: -injunction -criminal action--fines, imprisonment, or both -seizure of products -warning letters

Define drug

A) Articles recognized in the: -United States Pharmacopoeia (USP)/National Formulary (NF) -Homeopathic Pharmacopeia -Or any supplements of any of the references above B) Articles intended for use in diagnosis, cure, mitigation, treatment or prevention of disease in man or animals C) Articles other than food intended to affect the structure or function of the body in man or animals D) articles intended for use as a component of any articles A), B), or C)

Official Compendia

USP/NF: -published by the US Pharmacopeial Convention (USPC) -sets uniform standards -works closely with FDA but is private Homeopathic Pharmacopoeia of US-UPUS -publishes standards for homeopathy products by HPCUS, a private org -role and legal authority of HPUS Pursuant to FDCA, if a drug is recognized in USP or HPUS the drug product must meet all standards of the compendia

Pregnancy Category A

adequate and well-controlled studies in pregnant women have not demonstrated a risk to the fetus. The labeling for drugs in this category also must contain a notice that because studies cannot rule out the possibility of harm, however, the drug should be used during pregnancy 'only if clearly needed'

Define 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 NF/USP 2)intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals 3) intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its principal intended purposed 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 any of its principal intended purposes

Define label

display of written printed or graphic upon the immediate container of any article.

Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006)

requires manufacturers to report serious adverse events

Define labeling

written or printed or graphic matter 'accompanying' the article.