MPJE - Food & Drug
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| Pure Food and Drug Act (1906) | Several loopholes - labels not required to identify contents
Did not provide ability to ban unsafe drugs
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| Harrison Narcotic Act (1914) | Required license to import/export opium
Limited to medical and legitimate use only
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| Food Drug & Cosmetic Act (FDCA) (1938) | Prompted by the 1937 "Elixir of Sulfanilamide" tragedy
Required drugs to be tested for SAFETY prior to approval
Expanded the definitions of adulteration and misbranding
product labeling now had to include “Adequate directions for use”
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| Food Drug & Cosmetic Act (FDCA) (1938) | Placed drug advertising under the control of the Federal Trade Commission (FTC)
Later the advertising jurisdiction was changed to FDA = Rx & FTC = OTC drugs
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| Durham-Humphrey Amendment (1951) | “Caution: Federal law prohibits dispensing without a prescription
Provided provisions for Oral prescriptions and for prescription refills.
Distinguished between “Adequate Directions for Use” and “Adequate Information for Use”
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| Kefauver-Harris Amendments (1962) | Required drugs to be tested for efficacy prior to approval Created standards for manufacturer registration with the federal govt allowing for inspection of manufacturing facilities
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| Kefauver-Harris Amendments (1962) | Created standards for good manufacturing practices (GMP)
Created procedures for New Drug Approval process
Created the Drug Efficacy Study Implementation (DESI) program
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| Poison Prevention Packaging Act (1970) | Requires that all controlled substances and all prescription drugs are subject to special packaging requirements
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| Drug Price Competition Act (Hatch-Waxman Amendment) (1984) | provided a mechanism for accelerated drug approval process for generic versions of approved drugs that were approved after 1962 and whose patents are about to expire.
Created the “Abbreviated New Drug Application” (ANDA)
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| Prescription Drug Marketing Act (PDMA) (1987) | Establishes “DRUG PEDIGREES”
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| Prescription Drug User Fee Act (PDUFA) (1992) | Provides for annual fees on manufacturers and their products
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| Dietary Supplement and Health Education Act (DSHEA) (1994) | Removed dietary supplements from the NLEA; i.e., they are no longer classified as foods
Dietary supplement are now defined as a product intended to supplement the diet
they cannot claim that they diagnose, cure, mitigate, treat or prevent disease
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| Dietary Supplement and Health Education Act (DSHEA) (1994) | Labeling must state that “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
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| Food and Drug Administration Modernization Act (I, II, III) (1997) | Intended to promote efficiency in regulatory procedures
labeling requirements liberalized “Rx only” could replace the federal legend warning
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| Best Pharmaceuticals for Children Act (2002) | Designed to stimulate additional research into pediatric data for pharmaceuticals
Voluntary incentive to industry to sponsor pediatric studies
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| Pediatric Research Equity Act (2003) | Allows FDA to require research on certain pharmaceuticals before licensing
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| Drug | Recognized and intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and substances (other than food) intended to affect the structure or any function of the body of man or other animals
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| New drug | drug is not generally recognized as safe and effective for use under the conditions presented, recommended, or suggested in the labeling thereof
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| Prescription drug | Habit-forming drug
Not safe for use except under the supervision of a practitioner
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| Over-the-counter (OTC) drug | Safe and effective for use
Must contain “Adequate directions for use” - the directions must be written so clearly that a layperson can safely use the drug for its intended purpose(s).
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| NDA (New Drug Application) | A procedure for obtaining FDA pre-marketing approval of a drug,
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| ANDA (Abbreviated New Drug Application) | A procedure for obtaining FDA pre-marketing approval of a (generic) copy of a drug previously approved by the FDA.
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| Adulterated drugs | Primarily concerned with the physical conditions of drugs or devices
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| Adulterated drugs | Prepared, packaged or held in unsanitary conditions
Manufactured not in conformance with GMP
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| Adulterated drugs | Are in a container composed of poisonous or deleterious materials that may leech
Contains or is an unsafe color additive
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| Adulterated drugs | Varies from an official compendia
Is either a new unsafe animal drug or animal feed containing a drug
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| Adulterated drugs | Is a Class III device without premarket approval
An OTC drug not packaged in tamper-resistant packaging
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| Misbranded drugs | Primarily concerned with the representations made by the manufacturer
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| Misbranded drugs | Label or labeling is false or misleading
Label fails to state name and place of business of manufacturer…and accurate statement of quantity
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| Misbranded drugs | Label information is not prominently placed
Does not bear generic name in type not less than ½ size of the trade or brand name
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| Misbranded drugs | Listed in compendia, but not labeled and packed by compendia standards
Package or drug is misleading in the way it is filled or formed or is imitative of another drug
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| Misbranded drugs | Subject to deterioration and label does not warn
Health endangering if used in the manner suggested by the labeling
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| Label | upon the immediate container
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| Labeling | All labels and other written, printed or graphic matters
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| National Drug Code (1) | First Section – 4-5 characters representing the manufacturer or distributor (aka “Labeler”)
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| National Drug Code (2) | Second Section – 3-4 characters representing the “product”
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| National Drug Code (3) | Third Section – 1-2 characters representing the “packaging”
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| FDA Recall Class I Recall | Reasonable probability use will cause serious adverse health consequences or death
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| FDA Recall Class lI Recall | Use may cause temporary or medically reversible adverse health consequences Probability of serious adverse health consequences is remote
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| FDA Recall Class llI Recall | Use is not likely to cause serious adverse health consequences
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| FDA Recall Market Withdrawal | Minor violation that would not be subject to FDA legal action The firm (Mfg) removes the product from the market or corrects the violation.
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| Omnibus Budget Reconciliation Act 1990 (OBRA 90) | indirect approach by the federal government to regulate the pharmacy profession and health care industry.
Intent was to promote cost savings and better fiscal management
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| Omnibus Budget Reconciliation Act 1990 (OBRA 90) 3 Main components | Rebate programs
Demonstration projects
Drug Utilization Review (DUR) programs
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| Health Insurance Portability and Accountability Act (HIPAA) | Creation of electronic standards to simplify the transfer of electronic information between enterprises
Could jeopardize the privacy, confidentiality, and security of patient information
The HIPAA Privacy Rule is enforced by the DOJ-OCR
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| Medicare/Medicaid Fraud and Abuse Act | prohibits knowingly making a false statement of a material fact in any application for a benefit or payment
Many of the state actions are coordinated through the state Attorney’s General (AG) office and Medicaid Fraud Control Units (MFCUs).
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| Medicare/Medicaid Fraud and Abuse Act Antikickback provision | knowingly and willfully soliciting, receiving, offering, or paying any remuneration in exchange for inducing referrals or for furnishing any goods or services paid for by Medicare or Medicaid.
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