78 terms

Food, Drug & Cosmetic Act

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When did the North Dakota Pharmacy Ownership Law begin?
in 1943
What is the Commerce Claus
-congress shall have the power to regulate commerce with foreign nations, among the sveral states, and with the Indian tribes
When was the Import Drug act?
1848
What was the importance of Import Drug Act of 1848?
-prohibited importation of adulterated drugs
-passed due to distribution of adulterated and sub-potent anti-malarial medications to U.S. troops
When was the Pure Food and Drug Act made (Wiley-Heyburn Act)?
1906
What was the importance of the Pure Food and Drug Act of 1906 (Wiley-Heyburn Act)?
-prohibited adulteration and misbranding of food and drugs in interstate commerce
-passed in response to public concern over unsanitary practices in the food and drug industry
When was the Sherely Amendment passed?
1912
What was the importance of the Sherely Amendment?
-prohibited false and fraudulent efficacy claims
-passed in response to government failure to prosecute violations under the 1906 Act
When was the Food, Drug, and Cosmetic Act passed?
1938
What was the importance of the food, drug, and cosmetic act?
-required that safety of drug be proven before marketing
-passed in response to the "sulfanilamide elixir disaster"
When was the Durham-Humphrey Amendment enacted?
1951
What was the significance of the Durham-Humphrey Amendment?
-provides for oral prescriptions and refills of prescription drugs
-passed in response to a pharmacists dilemma
When was the Kefauver-Harris Amendment enacted?
1962
What was the importance of the Kefauver-Harris Amendment?
-required proof of efficacy for FDA marketing approval
-passed in response to the "thalidomide disaster"
When was the Medical Device Amendment enacted?
1976
What was the importance of the Medical device Amendment?
-provided more regulation regarding safety and efficacy of medical devices
When was the Orphan Drug Act?
1983
What was the importance of the Orphan Drug Act
-provides tax and exclusive licensing incentives for manufacturers to develop and market drugs for treatment of "rare diseases or conditions" (<200,000 Americans)
When was the Drug Price Competition and Patent Restoration Act (Hatch-Waxman Act)?
1984
What was the importance of the Drug Price Competition and Patient Restoration Act (Hatch-Waxman Act)?
-extended the ANDA process to generic versions of drugs first approved and marketed after 1962
-required FDA to approve generic drugs shown "bioequivalent" to previously approved drugs
-extended patent or market exclusivity of some pioneer drugs (gives them at least 5 years of exclusive marketing)
-helped speed approval of generics (can use Abbreviated New Drug Application)
When was the Prescription Drug Marketing Act?
1987
What was the importance of the Prescription Drug Marketing Act
-provided barriers to the establishment of secondary or diversionary distribution systems
-sales restrictions and recordkeeping requirement for samples
-prohibiting certain resale of Rx drugs
-bans re-importation of drugs
-requires state licensing of drug wholesalers
When was the Prescription Drug User Fee Act
1992
What was the importance of the Prescription Drug User Fee Act?
-authorized FDA to charge fees to cover the costs incurred for review of drug applications and other activities
When was the Nutrition Labeling & Education Act
1990
What was the importance of the Nutrition Labeling & Education Act?
-mandates nutrition labeling on food products
-allows health claims on product labeling under certain circumstances
When was the Dietary Supplement Health and Education Act
1994
What was the importance of the Dietary Supplement Health and Education Act?
-allows additional health benefit claims
-regulated more like food than drugs
When was the food & Drug Administration Modernization Act?
1997
What was the importance of the Food & Drug Modernization Act?
-pediatric drug studies
-pharmacy compounding
-PET compounding
-expediting Study and Approval of Fast Tract Drugs
-clinical trial information on drug for serious and life-threatening diseases
-elimination of certain labeling requirements
-dissemination of off-label treatment information
Who is responsible for administering the FDCA?
-the secretary of Health and Human Services (HHS), but the majority of these duties are delegated to the Commissioner of the FDA
Summary of the FDCA
-ensure the marketplace has only safe, effective, and properly labeled drugs
-ensure the manufacturing of drugs is done in comliance with Good Manufacturing Process
-Prevent filthy, putrid, or decomposed drugs from entering market
-ensure prescription drugs are dispensed only w/ prescription
-ensure prescriptions are only refilled as authorized by prescriber
-ensure proper labeling of prescription drugs
-ensure OTC drugs are labeled for save consumer use
-allows for seizure of misbranded or adulterated drugs
-misdemeanor and felony penalties for violation
-broad inspection powers over factories, warehoused, etc.
-limited inspection power over pharmacies
Definition of Drug
-recognized in official compendia
-intended for use in Dx, Tx or prevention of disease in man or animal
-intended to affect the structure or any function of the body of man
Definition of food
1. articles used for food or drink for man or other animals
2. chewing gum
Definition of dietary supplement
contains:
-vitamin
-mineral
-herb or botanical
-amino acid
Nutritional support statments allowed on nutritional products by DSHEA
1. that it will benefit a deficiency disease as long as prevalence is provided
2. Describe role in supplements affect of structure or function of body
3. Decribes the MOA of how it acts to maintain structure or function
4. Describes the general well-being from consumption of supplement
Definition of device
-an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article that does not achieve any of it's purposes through chemical action within or on the body
Definition of label
-printed material affexed to the container
Definition of labeling
-printed material enclosed with the drug
What are the general requirements for labeling of nonprescription drugs?
-principal display panel including statement of identity of product
-name and address of manufacturer, packager, or distributor
-net quantity of contents
-NDC requested, but not reqired
-cautions and warnings
-adequate directions for safe and effective use
-use "drug facts" panel format
What is the "drug facts" panel format
-drug facts
-active ingredients
-purpose
-uses
-warnings
-directions
-other info
-inactive ingredients
-questions? (optional)
What are adequate directions for use of nonprescription drugs
-statement of conditions for which drug is intended
-normal dose and dosages for different ages and conditions
-frequency and duration of administration
-route of administration
-preparation for use
Pharmacy labeling of bulk products
-must have all general and specific labeling requirements for OTCs
-must comply with current good manufacturing practices
Labels on commercial containers of prescription drugs
-name and address of manufacturer/distributer
-ingredient information
-statement of identity-generic and proprietary
-quantity in weight or measure
-net quantity of package contents
-a statement of dosage or reference to the package insert for dosage information
-expiration date and lot number
-NDC (requested, not required)
Specific headings in package inserts
-description (proprietary and generic names)
-clinical pharmacology
-indacations and usage
-contraindications
-warnings
-precautions adverse reactions
-drug abuse and dependence
-overdosage
-dosage and administration
-how supplied
Prescription label requirements
-name and address of the dispenser
-serial number of the prescription
-date of the prescription or the date of filling
-name of prescriber
-name of the patient, if stated in the prescription
-directions for use, including precautions, if any, as indicated on the prescription
Labeling of unit-dose medications
-established name of drug and quantity of active ingredient per unit
-expiration date
-lot or control number
-name of manufacturer, packager, or distributor
-any statement required by compendia
Expiration date on repackaged unit-dose containers
-6 months post repackaging or 25% of time remaining on bulk package
-whichever is earlier
Labeling of ipecac syrup
-call physician, poison control center, or ER immediately for advice
-warning: keep out of reach of children
-do not use in unconscious people
-conditions when drug should not be used
-The usual dosage is 1 tablespoon in individuals over 1 yo
When is a drug or device considered adulterated?
-If it is filthy, putrid, or decomposed
-was prepared, packed, or held under unsanitary conditions
-was manufactured outside of good manufacturing practices
-It's strength, quality, or purity is below compendial standards
When is a drug or device considered misbranded?
-It's label is false or misleading
-It does not list required ingredients or meet other label content requirements
-It is not labeled with adequate directions for use
-Its advertising is false
If pharmacy sells misbranded or adulterated drugs, how do they avoid liability?
-If sale and delivery was in good faith
-If FDA is supplied records of the source of shipment
When are drugs considered prescription drugs?
-If they are habit forming
-If they are unsafe for use except under medical supervision
-If it is a new drug with approval limited to use under medical supervision
What statement must all prescription labels contain?
-"Caution: Federal law prohibits dispensing without a prescription"
-Under FDAMA, it only needs to state "Rx Only"
What must an Invesstigational New Drug (IND) form include?
-proof of preclinical testing on animals to substantiate safety in humans
-If not rejected w/in 30 days, clinical testing may begin
What is tested in Phase I clinical trials?
-drug toxicity
-metabolism
-absorption
-elimination
-in a small number of patients
What is tested in Phase II clinical trials?
-used in a limited number of patients for specific disease treatment or prevention, along with additional animal studies
What is tested in Phase III clinical trials?
-evaluates phase I and II to determine safety and efficacy
-largest amount of participants
What is tested in Phase IV clinical trials?
-post-marketing surveillance for adverse effects (unofficial)
What are Class I medical devices?
-devices in which controls are adequate to assure safety and efficacy
-devices with insufficient information to determine safety/efficacy, but have low potential for injury
What are Class II medical devices?
-devices where controls alone will not assure safety/efficacy
-controls in addition to safety standards assure safety/efficacy
What are Class III medical devices?
-devices that are supportive or sustaining human life
-present a potential unreasonable risk of injury
-subject to pre-market approval
When marketing pharmaceuticals, what is considered "fair balance" of drug information?
-a brief summary relating to SEs, contraindications, and effectiveness
When marketing pharmaceuticals, what is considered "full disclosure" of drug information
-including Drug Efficacy Study Initiative (DESI) drug classification (ineffective, possibly effective, probably effective, or ineffective as combination)
OTC sales may be made without a prescription except in which cases?
-dosages higher than recommended on the label
-has prescriber refill instructions
-it is for a schedule V drug
The FDCAs stance on unapproved use of medications
-a physician may lawfully prescribe in variance with the package labeling without FDA approval
-a physician's experimental use of approved drug does not violate federal law
-it would be in physician's and public's best interest to file an IND form in these circumstances
-a pharmacist may legally dispense an approved drug for an unapproved use
How long should records of invoices, prescriptions, and inventories be kept?
-as long as running of statute of limitations on crime (5-6 years)
Penalties for 1st conviction of criminal violation of FDCA
-one year imprisonment, fine, or both
-fines: if no death, up to $100,000. If cause death, up to $250,000
-corporations may be liable up to $5 million per count
Penalties for 2nd conviction of criminal violation of FDCA or conviction with intent to defraud or mislead
-imprisonment up to 3 years, fines, or both
When does the rule of Good Manufacturing Practices apply to pharmacists?
-a hospital pharmacy repackages drug products for its own use as well as for other hospital pharmacies
-a pharmacy chain repackages and relabels quantities of drugs for shipment to individual franchises
-similar repackaging and relabeling by individual pharmacists as members of an informal buying group
When was the Poison Prevention Packaging Act?
1970
What is the importance of the Poison Prevention Packaging Act to pharmacy?
-requires all human oral prescription drugs to be dispensed in safety packaging
When are prescription drugs not required to be dispensed in safety packaging?
-if not intended for oral administration
-dual-purpose packaging allowed
-prescrber requests it
-patient requests it
-if it is dispensed to institutionalized patients by institutional personal
What is the penalty if a pharmacist violates the Poison Prevention Packaging Act?
-he/she may be criminally prosecuted and imprisoned for not more than one year, a fine of $1,000, or both
-increased for subsequent offenses.
When does a package fail as a safety package?
-if >20% of tested children are able to gain entry
-if >10% of adults are unable to open package
When was the Omnibus Budget Reconcilation Act?
1990
What is the daily pseudoephedrine limit in the Combat Methamphetamine Act?
-3.6g
What is the 30 day purchase limit of pseudoephedrine in the Combat Methamphetamine Act?
-9g (7.5g mail)