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Federal Law Overview Flashcards

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1
Q

1820

A

Started to think about quality and purity but didn’t really do anything

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2
Q

Federal Food and Drug Act of 1906

A

Said things needed to be pure but didn’t define pure

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3
Q

Federal Food and Drug Act of 1906 was inadequate because?

A

False statement were made but not considered misbranding
Did not extend to cosmetics
Did not grant the authority to ban unsafe drug
Labels were not required

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4
Q

International Opium Convention of 1912 and Harrison Narcotic Act of 1914

A 
First attempt to control a drug class
Only specific licensed persons would be allowed to import or export opium & no opium prepared for smoking
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5
Q

Food, Drug and Cosmetic Act

A

Created the FDA

Require that only safe and properly labeled drugs

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6
Q

Durham-Humphrey Amendment of 1951

A

Legend: “Caution: Federal law prohibits dispensing without a prescription” or “Rx Only”
Authorized verbal refills and scripts
Created OTC vs Rx

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7
Q

1954: Harrison Narcotic Act

A

Permits oral scripts for some narcotic drug found to possess little potential for addiction

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8
Q

Kefauver-Harris Amendment of 1962

A

Drug Safety
“For Intended Use”
Proof of EFFECTIVEness, proof of safety, good manufacturing practices (GMP), FDA controlled drug advertising, and investigational drug procedures

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9
Q

Prescription Drug Marketing Act of 1987

A

Bans re-importation of RX and insulins
Bans the sale, trade, purchase of Rx samples
Mandates storages, handling and paperwork for samples
Prohibits resale of drugs purchased by a hospital or healthcare facility

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10
Q

Drug Compounding Quality Act

A

Allows facilities that compound sterile drugs to register with the FDA as an “Outsourcing Pharmacy” if they aren’t compound for individual patient use

Outsourcing pharmacy are permitted to compound sterile product without receiving patient specific prescriptions or medication orders

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11
Q

Drug Supply Chain Security Act

A

Provides for a uniform national framework for an electronic track and trace system for prescription drugs and sets national standards for states to license drug whole seller distributors

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12
Q

Transaction data is?

A

1) Transaction information: product name, strength, and dosage form; NDC number; container size and number of containers; date of transaction; and name and address of the person from whom ownership is being transferred and to whom
2) Transaction history: all prior transactions back to the manufacturer
3) Transaction statement: statement by the seller that the seller is authorized, received the product from an authorized person, receive the transaction information, did not knowingly ship a suspect or illegitimate product, has system and processes to comply with verification requirements, and did not knowingly provide false transaction information

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13
Q

Drug Abuse Control Amendment of 1965

A

Controlled use of depressants, stimulants and hallucinogens

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14
Q

Comprehensive Drug Abuse Prevention and Control Act of 1970

A

Consolidated the enforcement activities of the government that had been handled by competing agencies

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15
Q

DEA was created in what year?

A

1973

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16
Q

Medical Device Amendment of 1976

A

Safety and effectiveness of life-sustaining and life-supporting devices are now required to have pre-market approval of the FDA

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17
Q

Orphan Drug Act of 1983

A

Government offered some financial help if the drug company would make a drug for a disease that affects less than 200,000 people

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18
Q

Drug Price Competition and Patent Term Restoration Act of 1984

A

Waxman-Hatch Act
Abbreviated New Drug Application
Decreased the time necessary to obtain approval for generic drugs
If the FDA requires extra trials, they will give you more patent life

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19
Q

Prescription Drug Marketing Act of 1987

A

If one place can get a drug cheaper because of government aid, they cannot sell it for cheaper
CANNOT sale samples
Civil and criminal penalties for violation

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20
Q

Safe Medical Devices Act of 1990

A

Granted the FDA significantly broader authority – require manufacturers to recall a device that cause serious adverse health consequences

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21
Q

Dietary Supplement Health and Education Act of 1994

A

Dietary supplements are a special class of food with specific labeling and it defines the claims they can make

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22
Q

Food and Drug Modernization Act of 1997

A

Pediatric studies of drugs
Pharmacy compounding
Expediting study and approval of fast track drugs
Information programs on clinical trails for life-threatening disease
Elimination of certain labeling requirements

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23
Q

Food and Drug Administration Amendment Act of 2007

A 
Gave FDA significant authority
Risk Evaluation and Mitigation
Strategies (REMS)
DTC advertising Review
Toll-free ADR reporting
Track and Trace Technologies
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24
Q

Poison Prevention Packaging Act

A

Prevent accidental poisoning of young children (childproof lids)
Must comply or have “This package is for households without young children” on it
Prescribers can only request non-childproof lids for one drug

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25
Poison Prevention Packaging Act is governed by
Consumer Product Safety Commission CPSC
26
Poison Prevention Packaging Act what is covered
All oral prescription drugs unless the patient request otherwise
27
Poison Prevention Packaging Act Exemptions***
Sublingual NTG and chewable isosorbide dinitrate 10 mg or less Birth control Unit dosed Punch packages Inhalers Ointments Aspirin or APAP effervescents Potassium supplements in unit doses Sodium fluoride no more than 264 mugs Erythromycin oral less than 8 mg tablets less than 16 mg Prednisone tablets no more than 105 mg per package Methylpresnisolone tablets no more than 84 mg per package Mebendazole tablets no more than 600 mugs Betsmethasone tablets no more than 12.6 mg Pancrelipase preps Sucrose preps in glycerol and water
28
Omnibus Budget Reconciliation Act of 1990
Fixed terms of reimbursement by the Federal Government to state governments as part of Medicare and Medicaid
29
Establishment of a Drug Review Program by States
Prospective Drug Review Program Screens each prescription at the point of sale or point of distribution COUNSELING
30
Retrospective Review Board
Conducts periodic exams of claims data and detect fraud, overuse, or inappropriate or medically unnecessary care among physicians, pharmacists and individuals receiving benefits under the program
31
Omnibus Budget Reconciliation Act of 1990 Three Things it implemented
Prospective Drug Use Review Patient counseling Maintaining proper patient records
32
Patient Counseling standards
Required states to establish standards governing patient counseling for Medicaid patients States extended to ALL patients
33
Maintenance of Patient Records
Most information is from the patient and must make a good effort to keep an up to date patient record
34
Pharmacists Counseling is based on
what the pharmacists deems to be significant
35
Anabolic Steroids Control Act of 1990
Required anabolic steroids to be placed in Schedule III
36
What is an anabolic steroid
Any drug or hormonal substance chemically and pharmacologically related to testosterone that promotes muscle growth
37
Health Insurance Portability and Accountability Act
Privacy, security, transaction ad code sets, and identifier rules
38
Privacy Provision
Applies to health information created or maintained by HCP who engage in certain electronic transactions, health plans and health care clearinghouses
39
What does HIPPA require
Protection of confidentiality and security of heath care data through creation and enforcement of standards
40
Protected Health Information PHI
All patient identifiable information
41
When can pharmacies use and disclose PHI without patient authorization?
To provide treatment, for payment, and for healthcare operations
42
HITECH Act
Added a breach notification requirement to HIPPA which requires notification for individuals of a breach of their unsecure PHI within 60 days, BAs must report any breach
43
Define Breach
Unauthorized accusation, access, use, or disclosure of PHI that compromises it security or privacy
44
What is a drug?
Intended for the use in the diagnosis, cure, mitigation, treatment or prevention of disease
45
What is cosmetic?
Intended to be rubbed, poured, sprinkled, or sprayed on, introduced into/applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance
46
Cosmetic special properties?
No classes No FDA approval Doesn't not make a therapeutic claim
47
What is the third class of drugs?
Drugs available only through a pharmacists | Should have been like OTCs
48
A drug is adulterated if?
FORMULATION OR IMPROPER STORAGE It contains any filthy, putrid or decomposed substance, prepared under unsanitary conditions, no GMP compliance, container with deletrious substance, unsafe color additive or mixed with something that reduces strength or quality
49
What is the most common example of misbranding?
Pharmacist refills a prescription without authorization from prescriber
50
Class I
Recall for product that will cause serious or fatal consequences
51
Class II
Recall is for a drug or device that may cause serious but reversible health effects
52
Class III
Recall for products that are not likely to cause adverse health consequences
53
FDA's Regulatory Action
Injection or restraining order from court Seizure of embargo Regulatory letter
54
Phase I
Smallest group of people | Mainly looking at safety and route of administration
55
Phase II
Small group of people WITH the disease
56
Phase III
``` Multi-site data colleciton process Pooled data outside of US Safety and efficacy in the intended use group Largest number of patient Takes the longest time ```
57
Phase IV
Any data collection or studies that go on after the drug hits the market Trends can emerge here
58
Abbreviated New Drug Application
Streamlined and expedited the process to get a drug to the general public Prove that your product has bioavailability of the name brand
59
Define label
Affixed to the container of the drug
60
Define labeling
Printed information that accompanies the drug
61
Prescription label has to have (federal law)?
``` Name and address of dispense Seriel number Date of filling Name of prescriber Name of patient Direction for use Precautions ```
62
Prescription label has to have (state law)?
``` Address of patient Initials of dispensing pharmer Telephone # of pharmacy Drug name, strength, manufacturer's lot number Beyond use date Name of manufacturer or distributor ```
63
Labeling of Manufacturer's container must have
``` Drug's identities and quantity Declaration of new quantity Usual dosage Rx only Route of administration Habit forming Lot or control number Name and place of business Expiration date ```
64
Labeling must have?
``` Description/Names Pharmacology Indication/Usage Contraindications Warnings Precautions Adverse Reactions Drug abuse/dependence Overdosage Dosage How supplied Date of most recent revision ```
65
A rated products are?
Determined to be bioequivalent and are thus therapeutically equivalent to the brand name
66
B rated products are?
Are found not to be bioequivalent
67
AB rated products are?
Actual or potential bioequivalence problems that have been fixed and now meets necessary bioequivalence requirements
68
AA
No known or suspected bioequivalence issues | Conventional dosage forms
69
AN
No known or suspected bioequivalence issues | Solutions and powders for aerosolization
70
AO
No known or suspected bioequivalence issues | Injectable oil solutions
71
AP
No known or suspected bioequivalence issues | Injectable aqueous solutions
72
AT
No known or suspected bioequivalence issues | Topical products
73
Federal Hazardous Communication Standard
Pharmacies are required to have a written hazardous communication plan including a list of hazardous chemicals in the workplace, must ensure all such products are appropriately labeled and have a safety data sheet, and must include training for all workers on hazardous chemicals, appropriate protective measures, and where and how to obtain additional information
74
Federal Hazardous Substances Act
Intended to protect consumers from hazardous and toxic substances Requires the label on the immediate package to have the following information: - name and business address of manufacturer distributor or seller - common or usual or chemical name - signal word "danger" for products that are corrosive extremely flammable or highly toxic - signal word "caution" or "warning" for all other Hazardous products - affirmative statement of the principal hazard (flammable, harmful if swallowed, causes burns) - precautionary statement telling users what they must do or what actions they must take to avoid - instruction for first aid treatment - word poison for a product that is highly toxic - special care in handling and storage - statement saying "keep out of the reach of children"

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