Brainscape's Knowledge GenomeTM


Top Flashcards (Certified)
All Flashcards

Texas Pharmacy Law > Federal Laws And Rules > Flashcards

Federal Laws And Rules Flashcards

(71 cards)

Start Studying
1
Q

1938 Federal Food, Drug, and Cosmetic Act

A

Safety standards only; no efficacy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

1951 Durham-Humphrey Amendments

A

Created OTC and Rx categories

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

1962 Kefauver-Harris

A

Requires efficacy in addition to safety

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

1976 Medical Device Amendment

A

Added regulatory authority over device

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

1983 Orphan Drug Act

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

1997 FDA Modernization Act

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

1999 OTC Labeling requirements

A

Standardized OTC labeling

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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?
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

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

A

Must be written and filled as a prescription

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Recalls - does the FDA have authority to recall drugs?

A

No, only devices

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Pregnancy categories

A

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

Pregnancy
Lactation
Male/female reproductive capability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

1906 Pure Food and Drug Act

A

Purity standards only, no efficacy required

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

What does the FDA NOT regulate?

A

Does NOT regulate practice of medicine, pharmacy

Regulates drugs, food, cosmetics, medical devices

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Define Biological products

A

Isolated from natural sources

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

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

A

Must disclose presence and may cause allergic reactions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Special warnings : aspartame
Phenylketonurics: contain phenylalanine
26
Special warning : sulfite
Disclose and allergy warning
27
Special warning: mineral oil
Only take at bedtime No infants unless under physician supervision Cannot encourage use during pregnancy
28
Special warnings: wintergreen oil - methyl salicylate
If more than 5%, must include warning that if used other than directed may be dangerous Keep out of reach of children
29
Special warning : Ipecac syrup
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
Special warning : phenacetin
Possible kidney damage
31
Special warning : salicylates
Reye's syndrome in children Pediatric ASA 1 1/4 grain (81mg) - no more than 36 tablets in container
32
Special warning : Tylenol
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
Special warnings: NSAIDs
NSAID must be prominently displayed Stomach bleeding warning Ask doctor before use if at increased risk for stomach bleeding
34
Who regulates prescription drug ads?
FDA
35
Who regulates OTC drug ads?
FTC - federal trade commission
36
Who regulates pharmacy advertising and how?
FDA - compounding pharmacies advertising compounded medications cannot advertise therapeutic claims
37
What is drug price advertising and how can it be exempt from FDA regulations?
"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
What must be packaged in tamper-evident packaging?
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
Describe the three FDA enforcement methods
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
Describe patient package inserts and when they are required
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
Which drug classes and biologicals require Medication Guides?
``` 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
Which drugs have REMs?
``` Mifepristone - mifeprix Accutane - isotretinoin Clozapine - clozaril Lotronex - alosetron Thalomid - thalidomide Tikosyn - dofetilide Tracleer - bosentan Xyrem - GHB Tysabri - natalizumab ```
43
REMs for Mifepristone
Should not be dispensed from pharmacies
44
REMs for Accutane
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
REMs Clozaril - clozapine
Monitor for fatal rxn of agranulocytosis | May only dispense enough until next blood test
46
REMs Lotronex - alosetron
Only for women with severe D-prominent IBS | - requires sticker affixed
47
REMs for Thalomid - thalidomide
STEPs program
48
REMs Tikosyn - dofetilide
Only available to retail pharmacists in TIPs - verify physician participated in educational program - stamp
49
REMs Tracleer - bosentan
For pulmonary arterial hypertension | Monitor for liver toxicity through TAP
50
REMs Xyrem - GHB
Only processed through centralized pharmacy | Med guide required
51
REMs Tysabri - natalizumab
TOUCH program - only available to those who register - MRI required - status report to manufacturer
52
What is the time frame for record keeping ?
2 years - FDA, DPS/DEA, TSBP | 3 years - exception for CE ACPE certs, Medicare part D original copy (electronic for 10 years)
53
What is the difference between compounding and manufacturing?
Compounding is a process done by the pharmacy and manufacturing is done by the manufacturer and regulated by the FDA
54
What is the primary source for determining generic equivalency?
FDA Orange Book - Approved Drug Products with Therapeutic Equivalence Evaluations
55
Describe the coding system of FDA Orange Book
``` 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
When is a substance considered highly toxic?
When a single oral dose of 50mg or less per kg body weight will kill half of rats
57
Who administers and enforces the Poison Prevention Packaging Act?
Consumer Product Safety Commission CPSC
58
What is the purpose of the Poison Prevention Packaging Act? What are the requirements? Does it cover dietary supplements?
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
What are general exceptions to child resistant containers?
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
What are OTC drug exceptions to child safety caps
ASA/APAP effervescent
61
Which OTC need child resistant caps?
``` Methyl salicylate > 5% Methanol > 4% unless in pressurized can spray Iron > 250mg Benadryl > 66 mg NSAIDs ```
62
All Rx drugs require child safety caps except for:
SL NTG | SL/chewable isosorbide dinitrate
63
What are US postal regulations?
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
What is PHI?
Protected health information (TPO) Treatment Payment Operations Cannot release for marketing purpose
65
What are patient rights associated with PHI?
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
What does "minimum necessary" not apply to?
Treatment purposes - Rx transfers, Rx information to physicians If authorization was signed by patient
67
What is OBRA90?
Expansion of Medicaid | Mandatory prospective DUR and patient counseling
68
What are the penalties for HIPAA Violations?
If entity did not know: $100; $25,000 If reasonable/not negligent: $1000; $100,000 Willful neglect - corrected
69
What does HIPAA Security pertain to?
Electronic information
70
HITECH Act pertains to?
Includes Business Associates
71
How many days must covered entities provide patients EHR that have a written request?
15 days

Texas Pharmacy Law (1 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions