Federal Law Exam FD&C Act PDF
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Summary
This document provides an overview of federal laws related to drugs and cosmetics. It covers various acts like the 1914 Harrison Narcotics Act and the Federal Food, Drug, and Cosmetic Act (FD&CA), encompassing topics such as labeling requirements, manufacturing practices, and more. It also explores the different processes for approving new drugs or devices, such as the NDA and ANDA applications.
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Federal Law Exam FD&C Act 1914 Harrison Narcotics Act - Establishes a record-keeping requirement for the receipt and dispensing of opium and coca leaves - Tax was assessed for dispensing these products...
Federal Law Exam FD&C Act 1914 Harrison Narcotics Act - Establishes a record-keeping requirement for the receipt and dispensing of opium and coca leaves - Tax was assessed for dispensing these products - Physicians are allowed to prescribe these as legitimate course of treatment for patient other then a drug addict - Possesion of narcotics without prescription became illegal Federal Food, Drug and Cosmetics Act (FD&CA) SCOPE and PURPOSE - FDA has the primary responsibility of enforcing the FD&C act - Began with the Sulfanilamide disaster ORGINAL - Only required safetey not effectiveness - Directions for use - Adequate warning signs TODAY - Labeling safety and effectiveness of drug - Labeling and safety of food and cosmetics - CGMP Current Good Manufacturing Practice is required for manufacturers, distributors and 503 B pharmacies - Prescription drugscan only be distributed and dispenseto an individual pursuant of a prescription or directly administered by a physician or otherAUTHORIZED practitioner - Drug prescriptions can only be refilled as authorized 1 - Specific labeling is required for both non prescription and prescription drugs - A drug dispensed or distributed in violation of theActslabeling requirement is misbranding - A drug that contains filthy putrid and decomposed substances packaged or held in unsanitary conditions is deemed adulterated - FDA is authorized to limited inspections of pharmacies in certain circumstances - Manufactures or repackers must register with FDA FD&C Act began the approval process for new dugs - Process requires a NDA ( new drug application ) - It offered a grandfather clause that exempted drugs prior to the act. - Few exist today - Most that do obtain approval via a NDA or ANDA ( abbreviated new drug application) Durham Humphrey Amendment Happens before the Kefauver Harris Amendment - Defined prescription as legend drugs to distinguish them between OTC - Restricted sale of such drugs to prescription only - Authorized refills on prescription drugs Kefauver Harris Amendment - Caused by the Thalidomide disaster - First to require effectiveness before market - Increased scrutiny of safety - Defined the Current Good Manufacturing Practices (CGMP) - Minimum requirements for the methods, facilities, processing, packaging or holding of a product - Manufacturers, Repackers and 503 B pharmacies must engage in CGMP - Hospital that repackages - Pharmacy distribution center that repackages - Required the informed consent - FDA regualtes prescription drug advertising 2 - FTC ( Federal Trade Commission ) regulates non prescription drug advertising Medical Device Amendment Definition of Device - Instrument, Apparatus or Implant - No Chemcial Action Class I (LEAST Regulated) - Toothbrushes - Sethscope - Scissors - Needles Class II ( Needs to meet performance standards) - Insulin syringes - Electric heating pad - Thermometer Class III ( Must meet pre-market approval due to it be life-supporting or life-sustaining) - Pacemakers - Replacement heart valves Drug Price Competition and Patent Term Restoration Act - Extended the ANDA to generic drugs making process easier - Does Not need to test safety and efficacy through clinical test - Just needs to be bioavailability and bioequivalent to the innovator drug - Extended Patent life for Brand Drugs - Patent is a grant of property right to the inventor of the drug through the US Patent andTrademarkOffice - Patent is 20 years from first date of filing - Most manufacturers file for patent protection prior to the product marketing, the effective term is much less - The ACT added a 5 year extension - The extension cannot be more than 14 yearsfrom the date it was approved 3 Prescription Drug Marketing ACT (PDMA) - Bans the sale of sample drugs - Works toreduce health risks from diversion of prescriptiondrugs - States license Wholesale Distribution Orphan Drug Act - Encourages/ promotes development of drugs that treat rare diseases/ conditions Drug Efficacy Study Implementation Program (DESI) - Tests the effectiveness of drugs from 1938-164 Drug Quality and Security Act of 2013 (DQSA) - History - 2012 there was a fungal meningitis outbreak that was traced to a New England Compounding Center, this focused attention on pharmacies that were large-scale, non-patient-specific preparations of sterile products - Drug Supply Chain and Security Act - Tracks the distribution of drugs through a database - Compounding Drug act - Describes the conditions in which certain pharmacies are entitled to exemption from the FD&C, including - FDA labeling requirement - FDA approval prior to market - Compliance with the CGMP - 503 A Pharmacies(everyday pharmacy) are exempted from these if they follow: - Cannot compound large quantities in advance - Cannot compound copies of commercially available drugs - Cannot compound drugs that were removed from the market due to safety issues - Cannot compound without a prescription and Cannot of Medical Use 4 - A patient-prescriber-pharmacist relationship must be established - A licensed supervisor must finish compounding - Must comply with the UNITED STATES Pharamacopeia Standards - 503 B pharmacies to remain exempted from the above ( EXCEPT THEY STILL MUST COMPLY WITH CGMP ): - Will be inspected by the FDA on a risk base schedule - Provide information to FDA on products compounded and report any adverseevents - Can compound for office use and does not need a presrpition - Can compound large quantities in advance but distribution to a wholesaler is prohibited - A pharmacist must supervise compounding - May choose to volunteer to register with FDA Definition of a Drug - FD&C defines drug as - Articles recongized by the united states pharmacopeia - Artlices intended for use indiagnosis, cure, mitigation,treamtent, and prevetion of disease - Articles thataffectthe structure of any functionof the body Intented Use - The FDA looks at various documentation from the manufacturer to determine whether the product will regulate as a drug - Labeling of product, websites, and promotional pamphlet - The INTENT of the manufacturer or distributor is key to determining whether the product is a drug Legend Drugs - There drugs that if used, but becuause potential harm/toxicity, therefore must be under supervision of a licensed practitioner to issue such drugs 5 Bulk Container Prescription Includes: - Name and address of manufacturer and distributor, or packer - Established name of drug - Ingredient information - If other than oral use, must state inactive infromation and other routes of administration - Quantity in terms of weight or measure - Total net quantity of container - A statement of recommended or usual dose or reference to package insert - RX only or caution federal law prohibitsdispensingwithout a prescription - Identifying lot or control number - Directions for pharmacist regarding the container usage - Adequate information for use - Expiration date New Drug - Any drug tht has not received general recognition of being safe and effective by a medical expert OTC Drug - Safe and effective for general public - No need for supervision to utlize - Low abuse and misuse potential - Self disgnose, treat and manage conditions of being treated - Safety margin adequately insures that benefits of OTC availability outweighs risks OTC Drug Labeling Requirement - Active ingredient - Purpose - Inactive ingredient - Directions for use 6 - Warning signs - Use and Indcations Pregnancy and Nursing Labeling for OTC - Needs a warning sign that says “if pregnant or breast-feeding must consult health care professional prior to usage” Over Counter Labeling of Sodium Content - If for oral usage must be labeled sodium content per dosage unit Over Counter Labeling of Calcium - If for oral usage must be labeled Calcium content per dosage unit Over Counter Labeling of Magenisum - If intended oral use, shall be labeled Magensium content per dosage unit Over Counter Labeling of Potassium - If intended for oral use shall contain potassium content per dosge unit Adulteration - Putrid, filthy decomposed substances - Held, prepped, packaged in unsanitary conditions - Manufacutured contrary to CGMP - PA states Exposed to Fire Water and Extreme temperatures - Purity, quality , strength is different from which it purports or listed in the official compendial , can also be misbranding - Posinous and deleterious substance that may leak into content - Unsafe food coloring additive - Drug or substance has been added to reduce its quality or strength 7 Misbranding - Dispesned or distributed in violation of the FD&C labeling requirement - Label is false or misleading - Not labeled or packaged to compendial standards - Drug is misleading in the way its filled or imitative of another drug - Drug is subject to deteration and label does not bear such warning - Drug/device is harmful if used in the way the label describes - Not packaged according to Posion Preventation Packaging Act - No RX warning - Pharmacist sells drug without prescription or refills without authorization Expiration Date Non sterile unit does or single unit dose pharmacist must: - Affix a beyond use date that is no later than one year - Unless stability data or manufacturer states otherwise Ordinary presscription vials beyond use date is not later than: - Not later than one year from date of dispensed or manufacturer’s expiration date - Whichever comes earlier Dietary Supplement - Amino acids - Herbs - Minerals - Vitamins - These can be constitute, concentrate, metabolite, extract, or combination of above - Supplment the diet by increasing diet intake Can claim - Affect structure any function of body - Calcium supplement with Vitamin D for strong bones, and is good for maintaining a healthy heart 8 - Identification of mechanism utilizedto maintain structure and function - Fiber supplements helps maintain bowel regularity - Benefits from consumption of the supplement - Helps body adapt and promote physical performance - Benefits of nutrient deficiencydisease as long asthe prevalnace of the disease in the US is stated in the claim If the label contains the above claims it should state that “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease Cosmetics FD&C defines cosmetics - Cleasning, Beautifying, Promote attractiveness, Alter appearance all without altering or affecting body structure or function Cosmetics as Drug - Intended to treat or prevent disease or alter a body function To know if a cosmetic is a drug it would state on its label: does it claim it would prevent or treat disease? Homeopathic Drug Products and Herbal Products - Defined as any drug labeled homeopathic which is listed in the Homepathic Pharmacopiea of the United States - Homeopathy is the practice of treating the symptoms and disease which constitute disease with remedies that produced similar symptoms in healthy persons - Like treats like - Stimulates the person natural immune system and raises general level of health, heal illness Single Source - Drug product approved by FDA for active ingredient, dosage form, route of administration, and strength 9 Multisource - Drug products that are manufactured from several manufacturer Pharmaceutical Equivalence - Drug prodructs similar in dosage form, strength, and route of administration active ingredient. Must meet same compedia standards for purity quality strength and labeling Therapeutic Equivalent - Drug products that are pharmaceutical equivalent and bioequivalent - To determine if a drug product is a therapeutic equivalent: - Bioequivalent - Pharmaceutical Equivalent - Adequate labeling - Approved safety and effectiveness - Manufactured in compliance with the CGMP Bioavalibility - The rate the active ingredient of a drug product is avaible on the site of action Bioequivalent - Drug product that is pharmaceutically equivalent, same result of drug deliver with the same pharmokinetic properties Reference Listed Drug (RLD) - Standard in which all genric drugs are compared - RLD filed NDA - when RLD experies generic manufacturers files ANDA - Generics must demostrate same result as RLD 10 Pharmaceutical Alternatives - Same moiety but different dosages, strengths, complexities ORANGE BOOK - Products that provide same therapeutic effects A - Products - Therapetuically equivalent to other pharmaceutically equivalent products - AA:conventional dosage forms not presenting bioequivlanceproblems - AB: actual or potential bioequivalence problems resolved in vitro or vivo B- Products - Not therapeutically equivalent - Problem with DOSAGE FORM PA Substitution - A products can be substituted unless it has anarrowtherapeutic range like Coumadin and Lanocin (NTI) - B products CANNOT be substituted Biological Product - Vaccines, Various Toxoids, Skin-Skin substances, Blood-Blood products for transfusion - Manufacturer license is issued by the CBER - Center for Biologics Evaluation and Research Biosimilars - Unique biologic products from living organisms using recombinant technology. Highly similar to reference product 11 Vetinary Product - Gain approval through NADA - New Animal Drug Application - In edible products must be free of unsafe residues - Flea Control: - Topical: EPA - Oral: FDA remarket P I ndication on ost Market P egulation of C R GMP Requirement Label Review Advertising Required rescription P YES YES YES FDA YES Drugs OTC Drug YES YES YES FTC YES omeopathic H YES YES YES TC - OTC F YES Drug FDA - RX ietary D YES NO YES FTC YES Supplement Drug Approval Process Before a new drug can be marketed, federal law requires submission and approval and this process begins with: - Sponsor must submit a IND ( Investigational New Drug ) that includes: - Name of drug - Composition - Methods of Manufacuring - Quality Control - Preclinical non human studies - Pharmocological, Pharmcokinetic, and Toxicology studies - Outline of clinical studies proposed If FDA does not reject IND within30 daysthen clinicaltesting on humans may began: - Phase I: Small number of healthy inviduals to deterimine pharmcology and 12 toxicology, not efficacy - Phase II: Small number of individuals who have the disease to test efficacy - Phase III: Larger number of inviduals who have the disease - If results are favorable thenapply for a NDA - Phase IV: afterFDA approvalthen monitor any adverseeffects Expedited Approval Treat serious life threatening illness thatan therapeuticadvantage over existing treatments Drug Recall Class I - Exposure to product results in serious adverse effects on health or death Class II - Product may cause temporarily or medically reversible effects and chance of serious adverse effect on health is low Class III - Exposure to product is not likely to cause adverse health consequences Market Withdrawal - Product removed from market due to a minor violation is not subject toFDAlegal action FDA Inspection Inspectin must: - Reasonably limited - Resonable time - Resonable Manner 13 Inspector needs to present - Credentials - Notice of Inspection Approved Drugs May Be Used For Unlabeled Indications - Unapproved medical devices may be used by physician in lfe threatening situations where: - No alternative is available - No sufficient time to seek approval - Must substaniate use at a later time - Discouraged by FDA, prescribers may prescribe the drug for these unoffical indications using their professional discretion Investigational Drugs Used in General Public… Can be used by general population provided that: - Treatment protocol is submitted to FDA - Serious or life threatening disease - No comparable or satisfactory alternative - Drug must be in clinical trial seeking approval OTC Tamper Evident Packaging - One or more barriers indicating tampering - Hard to duplicate - Two-Piece hard gelatin capsules must be sealed with tamper evident technology Child Resistant Packaging - Posion Prevention Packaging Act requires child resistant caps on all legend drugs - 80% under 5 yr old cannot open and 90% of adults can open - Pt or Physician can request for non child resistant packaging, Orally or in Writing - ProductsEXEMPTEDfrom Child-Resistant Packaging - Aresol containers for inhalation therapy (inhalers) 14 - Oral contraceptatives cyclically administered - Sublingual nitroglycerin tablets - Prednisone tablets that are not more than 105 mg - OTC products thatMUSTcomply with the PPPA’s child resistant packaging - Loperamide - Diphenydramine - Acetaminophen - Mouthwashes - Naproxen Tax Free Alcohol - May be used for - Scientific - In treatment of patients - Medicinal or Mechanical purposes - Cannot be used for - Food - Beverage Ipecac Syrup Availbed for sale without prescription provide that: - In packaged in a quantity of 30 ml - Label states - “F or emergency use to induce vomiting in posioning. Before use call physician, posion control center, or hospital emergency room for advice” - “Warning - keep out of reach from children. DO NOT use in unconscious persons.DO NOT use with corrosicves such as alkalies strong acids, petroleum distlaltes.” - Usual dosage: 1 tables spoon (15 ml) over 1 year of age Temperature Ranges Cold: not more than 8 degrees Celsius 15 Cool: 8-15 degrees Celisus Room temp: temp in work area Controlled room temp: 15-30 degrees Celsius Warm: 30-40 degrees Celsius Excessive heat: Above 40 degrees Celsius Refrigerator:2-8 degrees Celsius Freezer:-20 and -10 degrees Celsius Expired products must be remove from operating stock USP 795: Nonsterile Compounds Standards for compounding quality nonsterile preparations - Requirements for the compounding process, facilities, equipements, components, documentation, quality control, and training USP 797: Sterile Compounding - National standard for the process, testing and verification of any compounded sterile preparations - Guidance in preventing microbial contamination and who is performing the compounding - Nonsterile ingredients must be sterilized before administration - Biologics, diagnostics, drugs, nutrients, and radipharmaceuticals that possess either of the above two characteristics adn which may include baths and soaks for live organs or tissue, implants, inalations, powders for injection, irrigations, metered sprays, ophthalmic and otic preparations USP 800: Hazardous Drugs According to the National Instiute for Occupational Safety and Health drug exhibits one 16 or more of the following 6 characteristics: - Carcinogenticy - Tereatogenicity or other developmental toxicity - Reproductive toxicity - Organ toxicity - Genotoxicity NO acceptable level of personnel exposure to hazardous drugs Personnel - Entity must have a designated person who is qualified and trained to be responsible for - Developing and implementing appropriate procedures - Overseeing entity compliance with this chapter and other applicable laws, regulations, and standards - Ensuring competency of personnel - Ensuring environmental control of the storage and compounding areas - MINIMIZE EXPOSURE TO PERSONNEL NO positive air flow is allowed - Laminar air flow ( LAF ) - Compounding aseptic isolator (CAI) Only Negative air flow is allowed Garb ( NEED FULL GARB ) - Personal protective equipment are based on function being performed - Gloves, gowns, head, hair, and sleeve covers, face and eye protection and respiratory protection Cleaning - Deactivation and disinfectionwith an oxidizer, cleaning with a germicidal detergent and disinfectioin with sterile alcohol ADMINISTERING - CLOSED SYSTEM DRUG TRANSFER DEVICES 17 USP 825: RADIOPHARMACEUTICALS Outlines minimal standards for preparing, compounding, dispensing, and repackaging sterile and nonsterile radiopharmaceuticals EPA 2019 Disposal Rule Bans international disposal of hazardous waste pharmaceuticals via toilets, sinks, drains - Flexible collodion, insulin, nasal sprays, scopolamine, silver nitrate, witch hazel - Exempts OTC nicotine patches, gum, lozenges from hazardous waste list Two categories of pharmaceutical waste: 1. Potentially creditable waste (unused or unadministered and unexpired less than 1 year past expiration date ) 2. Non-creditable waste (remove from container, returned to pharmacy after payment has been received, more than 1 yr past expiration, refused by pt after attempt to administer, free samples, unused IND) Bar Code Rule Requires bar coding, consisting of, at a minimum, the National Drug Code (NDC) number, on certain products administered to patient in hospitals in an effort to reduce medication errors. This rule applies to manufacturers, repackers, relablers, and private label distributors of the following products: - Prescription drugs, except physician drug samples, allergenic extracts, intrauterine devices, medical gases, radiopharmaceuticals, low density form fill, and seal containers that are not packaged with an over wrap. - Biological products. - Over-the-counter products dispensed pursuant to an order and that are commonly used in hospitals. 18 National Drug Code (NDC) 1074 - Manufacturer 0128 - ID of specific drug 04 - ID of package All prescription drugs marketed in the United States must have NDC numbers No federal requires NDC number on prescription labels or on individual dosage units FDA Unit-Dose Package Guidlines - Generic name and trade name - Quantity of active drug or drugs present - Name of manufacturer, packer, or distributor - Repacakger’s lot number - Expiration date REMS - Risk Evaluation Mitigation Strategy - Drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure benefits of the medication outweighs risks - Reinforce medication use behaviors and actions that support the safe use of that medication Mifepristone - FDA approved a REMS program for Mifepristone - Mifepristone and Misprostol were approved by the FDA for pregnancy termination. Pharmacies can achieve certification - Available at some FDA certified retail pharmacies subject to state laws and regulations 19 Pregnancy ( Including Labor and Delivery ) - The FDA requires the removal of all pregnancy categories A, B, C, D, and X from all drug product labeling. - If the drug has a scientifically acceptable pregnancy exposure registry for the drug, the labeling must contain a specified statement about the registry. - Label must contain a summary of the drug’s risks during pregnancy. - Include relevant information to help health care providers and counsel women - Disease-assoicated maternal, embryo or fetal risk - Dose adjustments during pregnancy and postpartum period - Maternal adverse reactions - Fetal, Neonatal adverse reactions - Effect of the drug on labor or delivery Lactation - Lable must contain summary of drug risks during lactation - Drug is systemically absorbed must include - Relevant info on the presence of the drug in human milk - Effects of the drug on breast fed child - Effects of the drug on milk production - Ways to minimize drug exposure in breast fed child - Avaible interventions for monitoring or mitigating the adverse reactions - Pertinent information about the data - Risk benefit statement, unless breastfeeding is contraindicated during drug therapy Females and Males of Reproductive Potential Labeling must include relevant information: a. Pregnacy testing or contraception is required or recommended before, during or after drug therapy b. Data suggests drug assocaited feretility 20 21
