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Texas Pharmacy Law > Federal Laws And Rules > Flashcards

Federal Laws And Rules Flashcards

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1
Q

1938 Federal Food, Drug, and Cosmetic Act

A

Safety standards only; no efficacy

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2
Q

1951 Durham-Humphrey Amendments

A

Created OTC and Rx categories

Certain insulins are OTC - humulin/novolin N, R, 70/30, 50/50

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3
Q

1962 Kefauver-Harris

A

Requires efficacy in addition to safety

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4
Q

1976 Medical Device Amendment

A

Added regulatory authority over device

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5
Q

1983 Orphan Drug Act

A

Incentives to create drugs for rare diseases - gives those companies longer patent life

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6
Q

1984 Drug Price Competition and Patent Restoration Act

A

Patent holders received 5 years of patent life because of the FDAs process to review drug apps

Stopped having to reshow efficacy again

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7
Q

1988 Prescription Drug Marketing Act of 1987

A

Banned reimportation of Rx drugs
Banned sale, trade, and purchase of Drug samples
- ok to have OTC samples ONLY in pharmacy but cannot sell or trade

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8
Q

1997 FDA Modernization Act

A

Requires “RX Only” on prescription legend, clarify between compounding/manufacturing

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9
Q

1999 OTC Labeling requirements

A

Standardized OTC labeling

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10
Q

Define Adultered

A 
Makeup or composition of drug
- filthy substance
- contamination
- unsafe color additive
- strength difference (5% ok)
Misfilled: drug has been substituted
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11
Q

Define Misbranded

A 
Refers to drug labeling
False or misleading
Manufacturers requires:
- name/address
- quantity
- strength
- information for use
- warnings
- expiration

Counterfeit drugs
Pharmacist filling without authorization from prescriber
No child resistant caps

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12
Q

Define OTC label requirements

A

IN QWDP

Identification
Name/address
Quantity
Warnings
Directions (laymans)
Panel
- active/inactive ingredient
- purpose
- indications
- warnings
- directions
- other
- questions?
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13
Q

Prescribed OTC dose higher than OTC limits - what is needed?

A

Must be written and filled as a prescription

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14
Q

Recalls - does the FDA have authority to recall drugs?

A

No, only devices

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15
Q

Recall Classes

A

Class I - reasonable probability to cause serious AE or death
Class II - may cause temporary or reversible AE
Class III - not likely to cause AE

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16
Q

Pregnancy categories

A

Changing from A, B, C, D, X to three categories

Pregnancy
Lactation
Male/female reproductive capability

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17
Q

Plan B rules - what age group is it available to?

A

CONSUMERS 17 years or older OTC

WOMEN 16 years and younger by Rx

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18
Q

1906 Pure Food and Drug Act

A

Purity standards only, no efficacy required

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19
Q

What are exceptions for having Rx samples?

A
  • Charitable organizations - nonprofit
  • Hospital/clinic
  • Indigent or low income pts at no or reduced costs
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20
Q

What did the Food and Drug Administration Amendment Act of 2007 establish?

A

REMs program - risky evaluation mitigation strategy

Drugs Requires side effects and toll free number statement

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21
Q

What does the FDA NOT regulate?

A

Does NOT regulate practice of medicine, pharmacy

Regulates drugs, food, cosmetics, medical devices

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22
Q

Define Biological products

A

Isolated from natural sources

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23
Q

Define “drug”

A

Recognized in USP, intended for use in diagnosis, cute, mitigation, treatment, or prevention of disease in man or animal

NOT food

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24
Q

Special warnings: yellow no. 5 tartrazine and no. 6

A

Must disclose presence and may cause allergic reactions

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25
Q

Special warnings : aspartame

A

Phenylketonurics: contain phenylalanine

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26
Q

Special warning : sulfite

A

Disclose and allergy warning

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27
Q

Special warning: mineral oil

A

Only take at bedtime
No infants unless under physician supervision
Cannot encourage use during pregnancy

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28
Q

Special warnings: wintergreen oil - methyl salicylate

A

If more than 5%, must include warning that if used other than directed may be dangerous

Keep out of reach of children

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29
Q

Special warning : Ipecac syrup

A

Must be boxed and red : for emergency use to cause vomiting in poisoning

Only sold in 1 is (30 ml) containers

Warning : keep out of reach of children. Do not use in unconscious persons

Dosage > 1 year old is 1 tablespoon PO

Fluid extract is 14x as potent as syrup

30
Q

Special warning : phenacetin

A

Possible kidney damage

31
Q

Special warning : salicylates

A

Reye’s syndrome in children

Pediatric ASA 1 1/4 grain (81mg) - no more than 36 tablets in container

32
Q

Special warning : Tylenol

A

Prominently displayed

Warnings for potential liver toxicity, use over recommended dose, using multiple APAP products, and with alcohol

Ask doctor before use with liver disease or warfarin

33
Q

Special warnings: NSAIDs

A

NSAID must be prominently displayed

Stomach bleeding warning

Ask doctor before use if at increased risk for stomach bleeding

34
Q

Who regulates prescription drug ads?

A

FDA

35
Q

Who regulates OTC drug ads?

A

FTC - federal trade commission

36
Q

Who regulates pharmacy advertising and how?

A

FDA - compounding pharmacies advertising compounded medications cannot advertise therapeutic claims

37
Q

What is drug price advertising and how can it be exempt from FDA regulations?

A

“Reminder advertising” - exempt if conditions are met:

  • provide price info with no info on safety, efficacy, or indications
  • contains brand name if any, generic, strength, form or price charged
  • may include availability of professional service as long as not misleading
  • price includes all mailing free and delivery but may be stated separately
38
Q

What must be packaged in tamper-evident packaging?

A

All OTC except for dermatological, dentifrice, insulin, or lozenges for retail sale

Any two-piece hard gelatin capsule must be sealed

All repackaging and resale are subject to same labeling requirements

39
Q

Describe the three FDA enforcement methods

A
  1. Civil procedure - seizure
  2. Civil procedure - injunction or restraining
  3. Administrative action - regulatory letter to cease distribution and notify health professionals and users
40
Q

Describe patient package inserts and when they are required

A

Written for patient to understand

  • oral contraceptives
  • estrogen products
  • progesterone products
  • for both new and refill prescriptions
  • failure to provide = misbranding

In hospital - same as community or prior to 1st administration AND every 30 days after

41
Q

Which drug classes and biologicals require Medication Guides?

A 
Accutane - isotretinoin
Antidepressants in children/teens
Long acting opioids
Coumadin
Forteo - teriparatide - osteosarcoma
Lindane
Lotronex - alosetron - constipation
Nolvadex - tamoxifen
NSAIDS
Remicade - infliximab
Trizivar - abacavir, lamvudine, zidovudine
Actiq - IR fentany
42
Q

Which drugs have REMs?

A 
Mifepristone - mifeprix
Accutane - isotretinoin
Clozapine - clozaril
Lotronex - alosetron
Thalomid - thalidomide
Tikosyn - dofetilide
Tracleer - bosentan
Xyrem - GHB
Tysabri - natalizumab
43
Q

REMs for Mifepristone

A

Should not be dispensed from pharmacies

44
Q

REMs for Accutane

A

IPLEDGE
“Responsible pharmacist registered”
Auth to dispense via phone or web
Rx picked up within 7 days of pregnancy test
If not, must be reversed by accessing iPLEDGE
30 day supply
No refill

45
Q

REMs Clozaril - clozapine

A

Monitor for fatal rxn of agranulocytosis

May only dispense enough until next blood test

46
Q

REMs Lotronex - alosetron

A

Only for women with severe D-prominent IBS

- requires sticker affixed

47
Q

REMs for Thalomid - thalidomide

A

STEPs program

48
Q

REMs Tikosyn - dofetilide

A

Only available to retail pharmacists in TIPs

  • verify physician participated in educational program
  • stamp
49
Q

REMs Tracleer - bosentan

A

For pulmonary arterial hypertension

Monitor for liver toxicity through TAP

50
Q

REMs Xyrem - GHB

A

Only processed through centralized pharmacy

Med guide required

51
Q

REMs Tysabri - natalizumab

A

TOUCH program

  • only available to those who register
  • MRI required
  • status report to manufacturer
52
Q

What is the time frame for record keeping ?

A

2 years - FDA, DPS/DEA, TSBP

3 years - exception for CE ACPE certs, Medicare part D original copy (electronic for 10 years)

53
Q

What is the difference between compounding and manufacturing?

A

Compounding is a process done by the pharmacy and manufacturing is done by the manufacturer and regulated by the FDA

54
Q

What is the primary source for determining generic equivalency?

A

FDA Orange Book - Approved Drug Products with Therapeutic Equivalence Evaluations

55
Q

Describe the coding system of FDA Orange Book

A 
A = equivalent
B = not equivalent
AB = necessary bioequivalent only to other drugs coded as AB
AA = conventional dosage forms (Oral)
AN = aerosolization
AO = injectable oils
AP = injectable aqueous
AT = topical
56
Q

When is a substance considered highly toxic?

A

When a single oral dose of 50mg or less per kg body weight will kill half of rats

57
Q

Who administers and enforces the Poison Prevention Packaging Act?

A

Consumer Product Safety Commission CPSC

58
Q

What is the purpose of the Poison Prevention Packaging Act? What are the requirements? Does it cover dietary supplements?

A

Child resistant containers

No more than 20% of child test group can open package after demonstration and/or if more than 10% of adults cannot

Cannot be reused

No to dietary supplement

59
Q

What are general exceptions to child resistant containers?

A

Patient or physician can request (does not need in writing)
Patient can request as a blanket, physician cannot
Bulk containers
Institutionalized patients
One OTC size to elder with label “not for households with children”

60
Q

What are OTC drug exceptions to child safety caps

A

ASA/APAP effervescent

61
Q

Which OTC need child resistant caps?

A 
Methyl salicylate > 5%
Methanol > 4% unless in pressurized can spray
Iron > 250mg
Benadryl > 66 mg
NSAIDs
62
Q

All Rx drugs require child safety caps except for:

A

SL NTG

SL/chewable isosorbide dinitrate

63
Q

What are US postal regulations?

A

Non controlled may be mailed by physician or pharmacist
- no alcoholic beverage, poisons, flammable
Controlled (narcotic/nonnarcotic II-V)
- can’t identify contents (no names)

64
Q

What is PHI?

A

Protected health information (TPO)

Treatment
Payment
Operations

Cannot release for marketing purpose

65
Q

What are patient rights associated with PHI?

A

Access - right to inspect/obtain PHI, 30 days
Amend - right to amend PHI, 60 days
Accounting - accounting of disclosures except for TPO, authorization figure, national security, correctional facility, law enforcement
- exempt: HITECH- must disclose all entities that maintain electronic records

66
Q

What does “minimum necessary” not apply to?

A

Treatment purposes - Rx transfers, Rx information to physicians
If authorization was signed by patient

67
Q

What is OBRA90?

A

Expansion of Medicaid

Mandatory prospective DUR and patient counseling

68
Q

What are the penalties for HIPAA Violations?

A

If entity did not know: $100; $25,000
If reasonable/not negligent: $1000; $100,000
Willful neglect
- corrected

69
Q

What does HIPAA Security pertain to?

A

Electronic information

70
Q

HITECH Act pertains to?

A

Includes Business Associates

71
Q

How many days must covered entities provide patients EHR that have a written request?

A

15 days

Texas Pharmacy Law (1 decks)

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