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Law
Chapter A
| Question | Answer |
|---|---|
| Required drugs to meet purity and strength standards | Pure Food and Drug Act (1906) |
| Prevented interstate commerce of misbranded & adulterated drugs | Pure Food and Drug Act (1906) |
| No government approval prior to product availability | Pure Food and Drug Act (1906) |
| No safety or efficacy requirements | Pure Food and Drug Act (1906) |
| Rampant false and fraudulent claims | Pure Food and Drug Act (1906) |
| Government required to prove intent to defraud before product removed | Pure Food and Drug Act (1906) |
| “key pharmacy law” – many amendments and acts | Federal Food, Drug, Cosmetic Act (1938) |
| Response to 107 deaths from diethylene glycol in Elixir Sulfanilamide | Federal Food, Drug, Cosmetic Act (1938) |
| Cosmetics and devices also covered | Federal Food, Drug, Cosmetic Act (1938) |
| New drugs cleared for safety before distributed – New Drug Application (NDA) | Federal Food, Drug, Cosmetic Act (1938) |
| Government no longer required to prove intent to defraud before product removed | Federal Food, Drug, Cosmetic Act (1938) |
| Created FDA | Federal Food, Drug, Cosmetic Act (1938) |
| Authorized FDA factory inspections | Federal Food, Drug, Cosmetic Act (1938) |
| Efficacy not required for approval | Federal Food, Drug, Cosmetic Act (1938) |
| No drug classes (Prescription / OTC) | Federal Food, Drug, Cosmetic Act (1938) |
| Created 2 classes of drugs | Durham – Humphrey Amendments (1951) |
| Created the prescription (Legend / Rx) class that is unsafe use without medical supervision | Durham – Humphrey Amendments (1951) |
| Created the Over-the-Counter (OTC) class that is safe for use without medical supervision | Durham – Humphrey Amendments (1951) |
| Efficacy not required for approval | Durham – Humphrey Amendments (1951) |
| Requires prescription for dispensing from qualified practitioner | Durham – Humphrey Amendments (1951) |
| Allows written Rx from licensed practitioner | Durham – Humphrey Amendments (1951) |
| Allows oral Rx reduced to writing & filled by pharmacist | Durham – Humphrey Amendments (1951) |
| Refills permitted if authorized | Durham – Humphrey Amendments (1951) |
| Administration and dispensing allowed by practitioner | Durham – Humphrey Amendments (1951) |
| Exempt from manufacturing labeling requirements | Durham – Humphrey Amendments (1951) |
| Requires prescriptions to have Name & Address of pharmacy | Durham – Humphrey Amendments (1951) |
| Requires prescriptions to have Rx | |
| Requires prescriptions to have Date of prescription or filling | Durham – Humphrey Amendments (1951) |
| Requires prescriptions to have Name of prescriber | Durham – Humphrey Amendments (1951) |
| Requires prescriptions to have Name of patient | Durham – Humphrey Amendments (1951) |
| Requires prescriptions to have Directions of use & cautionary statements | Durham – Humphrey Amendments (1951) |
| Required new drugs to be proven safe and effective for claimed use | Kefauver Harris Amendments (1962) |
| Increased safety requirements | Kefauver Harris Amendments (1962) |
| Required more clinical trials | Kefauver Harris Amendments (1962) |
| Enhanced FDA inspection authority | Kefauver Harris Amendments (1962) |
| Covers controlled use of depressants | Drug Abuse Control Amendments (1965) |
| Covers controlled use of stimulants | Drug Abuse Control Amendments (1965) |
| Covers controlled use of halucinogens | Drug Abuse Control Amendments (1965) |
| Laid the groundwork for Federal Controlled Substances Act of 1970 | Drug Abuse Control Amendments (1965) |
| Safety and effectiveness of medical devices | Medical Device Amendment (1976) |
| Safety and effectiveness of some diagnostic and laboratory products | Medical Device Amendment (1976) |
| FDA regulates medical devices | Medical Device Amendment (1976) |
| No drug to treat rare illnesses | Orphan Drug Act (1983) |
| Few patients + High R&D costs = $ loss or low profits -> little business incentive | Orphan Drug Act (1983) |
| Provides manufacturer $ incentives to produce and provide drugs for rare diseases and conditions | Orphan Drug Act (1983) |
| Extended patent -> increased profits | Orphan Drug Act (1983) |
| Created ANDA (Abbreviated New Drug Application) for generics | Drug Price Competition and Patent Restoration Act (Hatch-Waxman) (1983) |
| No clinical trials for generics | Drug Price Competition and Patent Restoration Act (Hatch-Waxman) (1983) |
| Generics must be bioequivalent to pioneer drug | Drug Price Competition and Patent Restoration Act (Hatch-Waxman) (1983) |
| 1st generic manufacturer receive 180-day market exclusivity before other generics | Drug Price Competition and Patent Restoration Act (Hatch-Waxman) (1983) |
| Brand name manufacturers receive 5-year market exclusivity before generics submit ANDA due to patent life loss due to lengthy drug approval process | Drug Price Competition and Patent Restoration Act (Hatch-Waxman) (1983) |
| Primary source for determining generic equivalency for drugs | Orange Book |
| Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book |
| Therapeutically equivalent, no known or suspected bioequivalence problems | A |
| Therapeutically equivalent, actual or potential bioequivalence problems have been resolved supporting bioequivalence | AB |
| Not equivalent, actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence | B |
| Products must be A or AB rated to be ___ | generic |
| ___ letter relates to dosage form (except AB which indicates therapeutically equivalent) | 2nd |
| Assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading | 3 Character Code |
| Adalat® CC (AB1) and Procardia XL® (AB2), extended-release tablets, are listed under the active ingredient nifedipine. | not bioequivalent |
| Drug product selected by FDA upon which an applicant relies upon for ANDA. | Reference Drug List |
| drug product selected by FDA that an applicant seeking approval of an ANDA must use in conducting an in vivo bioequivalence study required for approval | Reference Standard |
| Prescription Drug Marketing Act (PDMA) (1987) | Prescription Drug Marketing Act (PDMA) (1987) |
| No selling, trading, or purchasing samples | Prescription Drug Marketing Act (PDMA) (1987) |
| No reselling Rx purchased by hospitals | Prescription Drug Marketing Act (PDMA) (1987) |
| No counterfeiting Rx coupons | Prescription Drug Marketing Act (PDMA) (1987) |
| No reselling Rx donated to charitable organizations | Prescription Drug Marketing Act (PDMA) (1987) |
| Allow drug importation | Medication Equity and Drug Safety Act of 2000 & the Medicare Prescription Drug Improvement and Modernization Act of 2003 |
| Finalized regulations that allow drug importation from Canada | FDA 2020 |
| Passed laws but not yet implemented that allow drug importation from Canada | Texas 2023 |
| Legend drugs identified by “Rx Only” | FDA Modernization Act (FDAMA) (1997) |
| Attempted to clarify compounding from manufacturing (update distinction) | FDA Modernization Act (FDAMA) (1997) |
| Miscellaneous Note: Veterinary products require “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.” (21 CFR 201.105) | FDA Modernization Act (FDAMA) (1997) |
| Established REMS (Risk Evaluation and Management Strategies) | Food and Drug Administration Amendments Act (2007) |
| Enhanced FDA post-marketing safety of drugs | Food and Drug Administration Amendments Act (2007) |
| Requires “Side Effects Statement” to include toll free number | Food and Drug Administration Amendments Act (2007) |
| Established abbreviated path for biological drugs that are “biosimilar” and may be “interchangeable” to FDA licensed biologicals | Biologics Price Competition and Innovation Act (2009) |
| “Purple Book” - “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations” | Biologics Price Competition and Innovation Act (2009) |
| Primary source for determining biosimilarity and interchangability | Purple Book |
| Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations | Purple Book |
| The single biological product, already licensed (approved) by FDA against which a proposed biosimilar or interchangeable product is compared | Reference Product |
| Approved based on a full complement of safety and effectiveness data | Reference Product |
| What a proposed biosimilar or interchangeable product is compared to and evaluated against to ensure that the proposed product is highly similar to, and has no clinically meaningful differences | Reference Product |
| A biological product that is highly similar to and has no clinically meaningful differences in terms of safety or effectiveness from an existing FDA-licensed (approved) product | Biosimilar |
| A biological product that meets the requirements for a biosimilar product and is approved based on information that is sufficient to show that it can be expected to produce the same clinical result in any given patient | Interchangeable |
| A biological product that is administered more than once to an individual where there is not a greater safety risk or risk of reduced efficacy from alternating or switching between products and its reference product | Interchangeable |
| Can be substituted for the reference product without the intervention of the prescribing health care provider | Interchangeable |
| Improved authority and funds for foreign facility inspections | FDA Safety and Innovation Act (FDASIA) (2012) |
| Title 1 – Compounding Quality Act | Drug Quality and Security Act (DQSA) (2013) |
| Addresses large scale compounding by pharmacies | Compounding Quality Act |
| Patient specific, regulated by states | 503A compounding |
| Non-patient specific; Outsourcing Facilities, regulated by FDA and states | 503B compounding |
| Large Dispensers no longer exempt as of 11/27/25 | Drug Quality and Security Act (DQSA) (2013) |
| Small Dispensers exempt until 11/27/26 | Drug Quality and Security Act (DQSA) (2013) |
| Title 2 – Drug Supply Chain Security Act | Drug Quality and Security Act (DQSA) (2013) |
| Implements uniform “track and trace” system for drug supply chain | Drug Supply Chain Security Act |
| Tracks and traces drug ownership using product identifier and providing of Transaction Data | Drug Supply Chain Security Act |
| Pharmacies must investigate and properly handle suspect products and illegitimate products | Drug Supply Chain Security Act |
| Used to notify FDA of illegitimate products | FDA Form 3911 |
| Timeline in which you must notify trading partners of suspect illegitimate product | within 24 hours |
| Administered and enforced by Consumer Product Safety Commission | Federal Hazardous Substances Act (1996) |
| Does not apply to drugs | Federal Hazardous Substances Act (1996) |
| Primarily applies to household products | Federal Hazardous Substances Act (1996) |
| Administered and enforced by Occupational and Safety Health Administration (OSHA) | Federal Hazardous Communication Standard |
| Classify hazards of chemicals | Safety Data Sheets (SDS) |
| Solid dosage form (tablets, capsules) | Exempt drugs |
| USP 800 | Nonexempt drugs |
| Drugs not in final solid dosage form for administration (liquids for compounding) | Nonexempt drugs |
| Primary requirement applicable to pharmacies | Poison Prevention Packaging Act of 1970 (PPPA) |
| Requires child resistant container for Rx drugs and certain OTC drugs | Poison Prevention Packaging Act of 1970 (PPPA) |
| Physician can’t give blanket request for non-childproof packaging | PPPA Exemption |
| Patient or physician may request for non-childproof packaging | PPPA Exemption |
| Bulk containers | PPPA Exempt |
| Packaging for drugs to institutionalized patients | PPPA Exempt |
| One OTC package size for elderly | PPPA Exempt |
| nitroglycerin packaging (for therapeutic reasons) | PPPA Exempt |
| Packaging of oral contraceptives | PPPA Exempt |
| Expansion of Medicare and Medicaid programs | Omnibus Budget Reconciliation Act of 1990 (OBRA-90) |
| Federally applied to Medicaid patients | Omnibus Budget Reconciliation Act of 1990 (OBRA-90) |
| Texas rules apply to all patients receiving pharmaceutical services (discussed under Class A rules) | Omnibus Budget Reconciliation Act of 1990 (OBRA-90) |
| Pharmacy relevant components include patient profiles, mandatory drug use review, and patient counseling | Omnibus Budget Reconciliation Act of 1990 (OBRA-90) |
| Medication regimen review every 30-days for patients of LTCF | CMS Requirements for Pharmacy Services at Long-term Care Facilities (LTCF) |
| Diagnosed and documented conditions for psychotropic drugs | CMS Requirements for Pharmacy Services at Long-term Care Facilities (LTCF) |
| PRN is max 14 days unless rational documented for psychotropic drugs | CMS Requirements for Pharmacy Services at Long-term Care Facilities (LTCF) |
| PRN renewal for psychotropic drugs requires reevaluation | CMS Requirements for Pharmacy Services at Long-term Care Facilities (LTCF) |
| Most brand name drugs cannot be dispensed in more than a 14-day cycle | CMS Requirements for Pharmacy Services at Long-term Care Facilities (LTCF) |
| Emergency drug kit required | CMS Requirements for Pharmacy Services at Long-term Care Facilities (LTCF) |
| Shipping noncontrolled substances via USPS | exempt |
| Shipping alcoholic beverages via USPS | non-exempt |
| Shipping poisons via USPS | non-exempt |
| Shipping flammable substances via USPS | non-exempt |
| Shipping controlled substances (Schedule II - V) via USPS | exempt |
| Enacted Tamper-Resistant Rx Requirements | Center for Medicare and Medicaid Services (CMS) |
| Written Rx on ___ paper | tamper-resistant |
| Does not apply if Rx is electronic, fax, phone, institutional patient, or managed care payor | tamper-resistant |
| Emergency fill permitted if prescription received within ___. | 72 hours |
| Research labs, hospitals or other locations using it may need permit and must follow recordkeeping requirements | Tax-free Alcohol |
| Tax-free alcohol only for research labs, hospitals or other locations using it may need permit and must follow recordkeeping requirements | Federal Alcohol Regulations |
| Expanded authority of pharmacists, interns and pharmacy technicians to provide COVID-19 vaccines, flu vaccines, and COVID-19 tests and therapeutics | Public Health Readiness and Emergency Preparedness Act (PREP) |
| Extended until 12/31/29 and then state law will apply | Public Health Readiness and Emergency Preparedness Act (PREP) |
| Texas has not made the authorities permanent under state law. | Public Health Readiness and Emergency Preparedness Act (PREP) |
| Refers to making health insurance “portable” by making it easier for people to continue their health insurance after leaving a job | Portability |
| Adopts standards for 8 electronic transactions (EDI – Electronic Data Interchange) and code sets to be used for submitting, processing, and paying claim transactions | Health Insurance Portability and Authorization Act of 1996 (HIPPA) |
| Pharmacies are covered entities in the Act and must be compliant with the regulations | Health Insurance Portability and Authorization Act of 1996 (HIPPA) |
| “Notice of privacy practices” – first service delivery to patient | Health Insurance Portability and Authorization Act of 1996 (HIPPA) |
| Pharmacies may use PHI for treatment, payment, and health care operations without authorization from the patient | Protected Health Information (PHI) |
| Persons or entities, other than members of a pharmacy‘s workforce, who perform a function or service on behalf of the pharmacy | Business Associates (BA) |
| Requires contracts under HIPPA | Business Associates (BA) |
| Patients have a right to inspect and obtain a copy of their PHI | Access (HIPPA) |
| HIPAA requires compliance within 30 days of request, but TSBP requires compliance within 15 days | Access (HIPPA) |
| Patients have a right to amend PHI or records containing PHI held by a covered entity | Amendments (HIPAA) |
| Pharmacies must comply within 60 days of request | Amendments (HIPAA) |
| Patients have a right to an accounting of disclosures of PHI made by the pharmacy | Accounting (HIPPA) |
| Amount of information disclosed to accomplish intended purpose | Minimum |
| Must have policies and procedures to protect from __ disclosure of PHI | accidental |
| ___ disclosures not a violation of the rules provided reasonable safeguards are in place | Unintended “incidental” |
| Privacy Official ___ | required |
| Enforced by Office of Civil Rights (OCR) | Health Insurance Portability and Authorization Act of 1996 (HIPPA) |
| Sets standards for administrative, physical, and technical safeguards to protect the confidentiality, integrity, and availability of ___ | PHI |
| Unauthorized acquisition, access, use, disclosure of PHI | Breach |
| Breach of ___ people involved Secretary HHS | >500 |
| Breach of >500 people involved Secretary HHS & prominent local media & affected people within ___ of breach discovery | 60 days |
| ___ devices with PHI should be encrypted | All |
| If individual, without patient consent, accesses, reads, scans, stores, or transfers PHI via a scanning device or electronic payment card | State felony |
| Wide range of products isolated from human, animal, or microorganisms produced by biotechnology methods | Biological Products |
| Vaccines | Biological Products |
| Blood and blood components | Biological Products |
| Allergenics | Biological Products |
| Somatic cells | Biological Products |
| Gene therapy | Biological Products |
| Tissues | Biological Products |
| Recombinant therapeutic proteins | Biological Products |
| Articles in an official compendium – USP/NF | Drug |
| Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease in a human or animal | Drug |
| Articles (other than food) intended to affect the structure or any function of the body of human or animal | Drug |
| Articles intended to be rubbed, poured, etc., into or on the body for the purpose of cleansing, beautifying, or altering the appearance of the body | Cosmetic |
| Display of written, printed, or graphic matter on the immediate container | Label |
| All labels of written, printed, or graphic matter upon the article or container | Labeling |
| All labels of written, printed, or graphic matter accompanying such article (package insert) | Labeling |
| Label on the product & any advertising & representations made by a detail person (manufacturer’s representative) | Labeling |
| Prohibited act that primarily deals with purity, cleanliness, and strength | adulteration |
| Quality problems at manufacturing facility | adulteration |
| False or misleading labeling in any way | Misbranding |
| Manufacturer’s label does not contain required elements | Misbranding |
| When Rx dispensed, it is exempt from FDA labeling requirements | Misbranding |
| Failure to include adequate information for use with a prescription drug product such as medication guide or patient package insert | Misbranding |
| Failure to meet OTC labeling requirements | Misbranding |
| Failure to meet Poison Prevention Packaging Act | Misbranding |
| Nonprescription Drug Product with an Additional Condition for Nonprescription Use | ACNU |
| Consumers must successfully complete an extra step to see if the drug is right for them before buying or using a nonprescription drug | ACNU |
| Makes sure that consumers can correctly choose and/or use the right drug product on their own without first consulting a health care professional. | ACNU |
| A questionnaire to determine if the drug is right for you. | ACNU |
| Hormonal Contraceptives: Estrogen-containing birth control pills (e.g., Plan B, but also daily pills) | Potential ACNU |
| Asthma Medications: Albuterol inhalers | Potential ACNU |
| Cholesterol Drugs: Statins | Potential ACNU |
| ED Medications: PDE-5 inhibitors | Potential ACNU |
| Other Chronic Conditions: Insulin, metformin, stronger acid reducers, or certain antibiotics | Potential ACNU |
| Dosed at night, not for infants or pregnancy | Mineral oil |
| Wintergreen oil (>5% methyl salicylate) | out of reach of children |
| Warning regarding Reye’s syndrome | Salicylates |
| Pediatric ASA – Not more than 36 tablets | Salicylates |
| liver toxicity, warfarin | APAP |
| “NSAID” displayed, “stomach bleeding warning” | NSAIDs |
| Fatal poisoning of children under 6 years old | OTC Products containing iron |
| dermatological, dentifrice, insulin, lozenges | Tamper Evident Packaging exceptions |
| Subject to Current Good Manufacturing Processes (CGMP) and labeling requirements of a manufacturer | Repackaging of OTC drugs |
| filled as Rx not subject to OTC labeling | OTC Drugs |
| If OTC filled as a prescription | prescription |
| Cannot be refilled if prescription | expired OTC prescription |
| OTC dose is different than indicated on labeling | requires prescription |
| Serious adverse effects on health or death | Class I Drug & Device Recall |
| Temporary or medically reversible adverse effects on health | Class II Drug & Device Recall |
| Not likely to cause adverse health consequences | Class III Drug & Device Recall |
| Prescription drug advertising | FDA |
| Over-the-Counter (OTC) drugs advertising | FTC |
| Advertising of drug prices (including by pharmacists) | reminder advertising |
| Advertising of drug prices (including by pharmacists) exempt from FDA advertising regulations if certain conditions are met (primarily specific pricing) | reminder advertising |
| Written by manufacturer for layperson | Patient Package Inserts |
| Required only for certain drugs for outpatient / community prescriptions & refills of oral contraceptives (Rx version) | Patient Package Inserts |
| Required only for certain drugs for outpatient / community prescriptions & refills estrogen products | Patient Package Inserts |
| Given to hospital patients prior to first administration | Patient Package Inserts |
| Given to hospitalized patients every 30 days thereafter | Patient Package Inserts |
| Failure to provide Patient Package Inserts | misbranding |
| generally required for outpatient only (new prescriptions & refills) | Medication Guides |
| Required when serious adverse effects could be prevented | Medication Guides |
| Required when serious risks relevant to benefits | Medication Guides |
| Required when adherence to directions is crucial | Medication Guides |
| Included with Accutane, Lotronex, Lindane, NSAIDS, Opioids, cough products, biologicals, anticoagulants, ADHD medications, benzodiazepines, HIV medications, TNF inhibitors | Medication Guides |
| Failure to provide Medication Guides | misbranding |
| Strategy to manage serious risks with certain drugs | Risk Evaluation and Mitigation Strategies (REMS) |
| May include restricted distribution; special training; certification for prescribers, pharmacists, or patients; monitoring; medication guides; etc. | Risk Evaluation and Mitigation Strategies (REMS) |
| Accutane (isotretinoin) iPledge program | Risk Evaluation and Mitigation Strategies (REMS) |
| Pharmacy must register “responsible pharmacist” | Risk Evaluation and Mitigation Strategies (REMS) |
| Authorization to dispense via Internet or phone | Risk Evaluation and Mitigation Strategies (REMS) |
| Rx must be picked up within 7 days of negative pregnancy test. | Risk Evaluation and Mitigation Strategies (REMS) |
| 30-day supply only, no refills | Risk Evaluation and Mitigation Strategies (REMS) |
| Opioid manufacturers required to make prepaid mail-back envelopes available to outpatient pharmacies | Risk Evaluation and Mitigation Strategies (REMS) |
| Often a component of specialty pharmacy practices | Risk Evaluation and Mitigation Strategies (REMS) |
| Physicians may legally prescribe (and pharmacists may dispense) drugs for ___ uses. | unapproved (off-label) |
| Pharmacists should use professional judgment to minimize liability for ___ | unapproved (off-label) |
| FDA generally prohibits manufacturers from promoting ___ uses except under certain conditions. | unapproved (off-label) |
| Not required to be on the manufacturer’s label | National Drug Code |
| Having an ___ does not indicate that a drug has been approved by FDA. | National Drug Code |
| The ___ segment of the NDC identifies the labeler | first |
| 0777 of the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. | labeler code |
| 3105 of the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. | product code |
| 02 of the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. | package code |
| Apply to repackaging drugs for sale or distribution to other pharmacies. | Current Good Manufacturing Practices (CGMP) |
| Texas law allows one hospital to ___ for another hospital under common ownership or control without being a manufacturer or wholesaler. | repackage |
| Product (except tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, herb or botanical, amino acid, and/or dietary substance used to supplement the diet of any ingredient above | Dietary supplement |
| B12 | Dietary supplement |
| Fe | Dietary supplement |
| fish oil | |
| Echinacea | Dietary supplement |
| Melatonin | Dietary supplement |
| Probiotics | Dietary supplement |
| protein powder | Dietary supplement |
| A food “formulated to be consumed or administered enterally under the supervision of a physician | Medical food |
| A food intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation | Medical food |
| Not drugs so no NDC and no “Rx Only” | Medical food |
| No written or oral prescription required | Medical food |
| Ensure, Boost, Glucerna, Pedialyte | Medical food |
| Places burden on FDA to prove that a dietary supplement is unsafe before removing from market | Dietary Supplement & Health Education Act |
| Dietary supplement states it treats a specific disease or condition | Prohibited claim |
| Dietary supplement states it prevent a specific disease or condition | Prohibited claim |
| Dietary supplement states it cures a specific disease or condition | Prohibited claim |
| Dietary supplement makes health claims | Permitted claim |
| Dietary supplement makes structure/function claims | Permitted claim |
| Dietary supplement makes nutrient content claims | Permitted claim |
| Requires dietary supplement manufacturers, packers, or distributors to report serious adverse effects to the FDA | The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 |
| Intended to be consumed under supervision of a physician, but are not drugs and are not prescription products | Medical food |
| Should not contain “Rx only” on label | Medical food |
| Instrument, apparatus, etc., intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease in a human or animal | Medical device |
| Intended to affect the structure or any function of the body of human or animal which does not achieve its intended purpose through chemical or biological action within or on the body | Medical device |
| “does not achieve its desired action by chemical action or being metabolized“ as a drug | Medical device |
| Classification based upon potential risks to human health | Medical device |
| Class I – lowest risk, little to no potential for harm | Medical device |
| Class II – moderate risk | Medical device |
| Class III – highest risk; sustain or support life; implanted; potential unreasonable illness or injury risk | Medical device |
| Prescription Devices | Medical device |
| Unique Device Identifier (UDI) | Medical device |
| “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.” | Veterinary legend |
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CaristW