Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Fl 2* > MPJE Federal > Flashcards

MPJE Federal Flashcards

1
Q
  • Prohibited foods and drugs to be distributed if adulterated or misbranded
A

Pure Food and Drug Act of 1906

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q
  • New drug cannot be marketed unless it was safe with directions of label
  • Required that labels include adequate directions for use and warnings about habit-forming drugs
  • First law that applied to cosmetic products
  • Drugs marketed prior to 1938 were grandfathered and did not have to be proven safe
A

Food, Drug, and Cosmetic Act

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q
  • Amendment to FDCA
  • Established 2 classes of drugs: legend and OTC
  • Drugs that required medical supervision required to include “Caution: Federal Law prohibits dispensing without a prescription”
  • Legend drugs
    o Adequate directions for use = pharmacist putting label with physicians directions
  • Nonprescription or OTC
  • Allowed for oral prescriptions and prescription refills
A

Durham-Humphrey Amendment of 1951

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q
  • Resulted aver concern of thalidomide (birth defects)
  • Amendment to FDCA
  • Drugs must be safe and effective
  • Prescription drug adverting must be regulated by FDA
    o OTC advertising is regulated by the FTC (Federal Trade Commission)
  • Required informed consent for clinical trials, reporting of ADRS, and creating good manufacturing practices
A

Kefauver-Harris Amendment of 1962

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q
  • Amendment of FDCA
  • Classification of medical devices by function, establishment of performance standards, pre-market approval requirements, GMP standards, and requirements for reporting
A

Medical Device Amendment of 1976

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q
  • Tax and licensing incentives to make developing orphan drugs more appealing
  • Rare disease = <200,000 people in the US
A

Orphan Drug Act of 1983

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q
  • Hatch-Waxman Amendment
  • Streamlined drug approval process for generic products
    o Only need an abbreviated new drug application (ANDA)
    o Does NOT require clinical testing
    o Requires proof of bioequivalence with brand name counterpart
  • Brand name products had incentive by gaining 5 additional years of patent protection
  • Patent does not have to expire before researchers begin
A

Drug Price Competition and Patent-Term Restoration Act

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q
  • More stringent controls on distribution of prescription drugs
  • Wholesalers by be licensed by states under federal guidelines
  • Banning re-importation of prescription drugs produced in the US
  • banning the sale, trade, or purchase of samples
  • specifying storage, handling, and records of drug samples
  • Prohibiting resale of prescription drugs purchased by hospitals or health care facilities
A

Prescription Drug Marketing Act of 1987

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q
  • Touches almost every aspect of FDAs activities
  • Fast track NDA for treatment of serious or life-threatening conditions
  • Extemporaneous compounding of prescriptions in pharmacies
    o States regulate compounding
    o Pharmacies are exempt from GMP
  • Prescription drug legend “Caution: Federal law prohibits dispensing without a prescription” replaced by “Rx Only”
  • “Warning- may be habit forming” was eliminated (FDCA)
  • Encouraged manufacturers to submit supplemental NDAs for uses
    o Can publicly disseminated limited info about unapproved uses – must specify not approved by FDA
  • Manufacturers get 6 months extra of marketing exclusivity if study in pediatric population
A

FDA Modernization Act of 1997

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q
  • No longer allowed to deny coverage to children with pre-existing illnesses
  • Children can stay on parent’s insurance until 26
  • No insurance for 6 months and receive subsidy to enroll in high-risk insurance companies by the state
  • All new insurance plans must exempt preventative care from deductibles
  • Businesses with < 25 employees receive up to 3.5% tax credit for providing health insurance to employees
  • Senior citizens in donut hole can get 50% discount on some drugs
  • W-2 forms to include cost of health care
  • Women’s Preventative Health Care Amendment – STD, contraception, etc
A

Affordable Care Act

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q
  • Not published by the government
  • Contains monographs of drugs
  • USP and NF are 2 separate entities even though published in 1 book
A

USP/NF

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q
  • Private organization that updates homeopathic products

* *without designation of USP/NF or HPUS the drug is considered misbranded or adulterated

A

Homeopathic Pharmacopeia of the US (HPUS)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q
  • Find labels for approved drug products
  • Find generics for a brand
  • Find all drugs with a specific active ingredient
  • View regulatory history
  • Find consumer information after 1998
A

Drugs@FDA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q
  • Price pharmacy pays for the drug. Discounted from the AWP
A

AAC- actual acquisition cost

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q
  • Average price paid by wholesaler to manufacturer
A

AMP- average manufacturer price

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q
  • Published wholesale price that can be used for pricing prescription drugs. Pharmacies usually purchase at a lower price
A

AWP- average wholesale price

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

complementary alternative medicine

A

CAM

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

department of health and human services

- Includes FDA

A

DHHS

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q
  • Can stand repeated use
  • Used for medical purpose
  • Appropriate for use in home
A

DME- durable medical equipment

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q
  • Estimated cost of drug to pharmacy based on info collected by DHHS
  • Costs are based upon quantity purchased
A

EAC- estimated acquisition cost

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q
  • Highest price allowed under a specific plan for a specific drug
  • If a person wants a more expensive drug, they must pay the difference
A

MAC- maximum allowable cost

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q
  • Excipients or adjuvants
A

GRAS- generally recognized as safe

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q
  • Used when considering OTC
A

GRASE – generally recognized as safe and effective

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q
  • Article intended to be rubbed, poured, sprinkled, sprayed or applied to human body for cleansing, beautifying or altering appearance
  • Soap is NOT a cosmetic
A

Cosmetic

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

instrument, apparatus, implant,

A

device

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

Part A

A

hospital

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

Part B

A

medical insurance for physican services

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

part c

A

medicare managed care (medicare advantage)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

part D

A

prescription drug

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

MMA- Medicare Prescription Drug Improvement and Modernization Act

A
  • Part A = hospital
  • Part B = medical insurance for physician services
  • Part C = Medicare managed care (Medicare Advantage)
  • Part D= prescription drug
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

CMS

A

centers for Medicare and Medicaid services

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

covers everything original Medicare covered with lower costs and extra services

A

MA- Medicare Advantage

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q
  • cannot enroll in Part _ and Medicare Advantage
A

D

PDP- prescription drug plan

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
34
Q
  • monthly premium, annual deductible, co-payments
    o premium and deductable cannot change Jan 1 – Dec 31st but copay can
  • based upon individual – spouses cannot share a plan
  • Tier 1 – least expensive generic
  • Tier 2- preferred brand
  • Tier 3- nonpreferred brand name
  • Tier 4- rarer, high cost drugs
  • Donut hole
    o Gap between initial coverage and catastrophic coverage
  • Covers vaccines
A

Part D

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
35
Q

Formulary requirements

A
  • Plans must include drugs within all therapeutic classes in USP
  • Companies who want to design their own plan must have P&T Committee
  • Insurers do not have to include all drugs, but there are 6 classes where they have to include most
    o Anticonvulsants
    o Antidepressants
    o Antineoplastics
    o Antipsychotics
    o Antiretrovirals
    o Immunosuppressants
  • Formulary changes must be given within 60 days to CMS
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
36
Q

medicare enrollment

A

3 months before and 3 months after their birthday

o 7 months

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
37
Q
  • Health insurance sold by private companies

- Cannot sell prescription drug plans

A

medigap

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
38
Q
  • Part D sponsors must provide MTM programs
  • Targeted quarterly
    o 2 or more disease states
    o Taking 2-8 drugs
    o Predicted to incur part D annual cost
  • Must target 4/7 core disease states:
    o HTN, HF, diabetes, dyslipidemia, respiratory, bone disea/arthritis, mental health
  • Report outcomes to CMS
  • Minimum requirements
    o CMR – comprehensive medication review
    o Targeted medication review
    o Interventions to prescribers- fax, mail, face to face
A

MTM

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
39
Q
  • 1st application to FDA before drug can be used on humans
  • Intended to protect rights and safety of humans
  • IND sponsors: pharmaceutical companies, researcher, academic personnel, organizations
  • FDA has 30 days to decide if drug can be tested on humans
A

IND- investigational new drug application

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
40
Q

Clinical Trials
- Phase : small group of healthy individuals
o Test toxicology, PK, and pharmacological properties

A

phase 1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
41
Q

Clinical trials
- Phase : larger group, 100 or more
o Patients with the disease
o Determine efficacy, info on dosing, relative safety, and adverse events

A

2:

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
42
Q
  • Phase : larger groups, sometimes thousands
    o Controlled clinical studies
    o Efficacy compared to placebo
A

3

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
43
Q
  • Can receive drug without being in study if have life-threatening illness
  • Drug must be in phase 2 or 3 (need safety and efficacy data)
A

treatment INDs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
44
Q

New Drug Application (NDA) process

A
  • Submit to FDA with data from phases 1, 2, and 3
  • If NDA is approved, manufacturer can market
  • After drug is marketed, phase 4 studies are conducted
    o Health professionals encouraged to report problems
    o Manufacturer must submit yearly reports
    o Phase 4 utilized to determine if drug should remain on the market
  • Manufacturers must describe manufacturering process for cGMPs
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
45
Q

FDA expedited review – for

A

life-threatening diseases or potential to provide large benefit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
46
Q

FDA expedited review:

1)
a. NDA or biologics license application
b. Reduces by 10-6 months

A

Priority review

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
47
Q

FDA expedited review:

2)
a. May be requested for IND prior to BLA or NDA submission
b. Intended for drugs with unmet need
c. Early reviews/meetings of their product

A

Fast Track

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
48
Q

FDA expedited review:

3)
a. Can request for IND or prior to end of phase 2
b. Must show early clinical evidence
c. Greater emphasis on early meetings

A

Breakthrough therapy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
49
Q

FDA expedited review:

4)
a. Discuss during development
b. Intended for drugs with long-term endpoints (mortality, etc)
c. Required to confirm efficacy in post-market trials

A

Accelerated approval

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
50
Q
  • Require less data but need to show PK data
  • 1st applicant to complete formal review will have 6 months of exclusive rights of the generic
  • Generic companies cannot be sued for defective design or failing to warn about drugs dangers
A

Abbreviated New Drug Application (ANDA) - generics

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
51
Q
  • After marketing changes to synthesis, manufacturing locations, production procedures, labeling
  • Do not need a new NDA
A

Supplemental new drug agreement

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
52
Q
  • Company that filed original NDA will probably at SNDA
A

ANDA vs SNDA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
53
Q
  • P= priority, no other effective drugs
  • S= standard/similar
  • P usually get reviewed more rapidly
A

Therapeutic Classification

54
Q
  • CDC buys at discounted rate and distributes them to health facility for those cannot pay
A

Vaccines for Children Program

55
Q

Naming Drugs

A
  • Short, distinctive, not likely confused

- Provide indication of therapeutic class

56
Q
  • 10 or 11 digits

- 4 manufacturer, next 4 specific drug, last 2/3 package

A

NDC

57
Q
  • Receives reports about bad adversting
A

OPDP= office of prescription drug promoton

58
Q

o Filthy, decomposed substance
o Prepared, packaged, or held with unsanitary conditions
o cGMPs not met during manufacturing
o unapproved color additive
o strength, purity, quality lower than standards
o drug not recognized by official compendia

A
  • Adulteration
59
Q

o false or misleading
o missing name or location of manufacturer, packer, or distributor
o does not contain a word required by law
o does not include name of active drug
o does not have each ingredient identified
o does not say Rx only for legend drugs
o does not contain precautionary statement that it is subject to deteriation
o missing quantity of container
o inadequate directions
o offers sale of the drug
o pharmacy dispensing Rx only rug without legal prescription or authorized refill

A
  • misbranding- labeling
60
Q

FDCA specified “adequate directions for use” and Durham-Humphrey clarified
- do not need adequate directions for legend drugs if intended to be dispensed by pharmacist

A

Labeling

61
Q

Labeling Requirements for Manufacturers Containers

A
  • name and address of manufacturer, packer, or distributer
  • established name of drug
  • net quantity
  • weight of active ingredient in each dosage
    o electrolytes require mEq
  • reads “Rx only” for legend drugs
  • routes must be stated IF NOT orally
  • storage directions
  • lot number
  • expiration date by the manufacturer
62
Q

Special Labeling Requirements

A
  • FD&C Yellow No 5 (tartrazine): allergic rxns
  • Aspartame – phenylaniline
  • Sulfite – allergic rxn
  • Mineral oil – only be used at bedtime and not in infants/pregnancy
  • Wintergreen oil – methyl salicylate
  • Sodium phosphate – amount in oral solution, no more than 90 mL
  • Isoproterenol inhalation – not exceed quantity prescribed
  • Ipecac Syrup, fluid extract is 14x as potent as syrup
    o Red for emergency use in poisoning, warning to keep out of children and do not use
    o 1 oz only
63
Q

Package Inserts:

A
  • Description
  • clinical pharmacology
  • Indications and usage
  • C/I
  • Warnings
  • Precautions
  • Adverse reactions
  • Abuse
  • Symptoms
  • Dosage and admin.
  • Dosage forms
  • Most recent revision of labeling
  • Usual dose
64
Q
  • Correct problem of drug diversion
  • Require distribution records, register in state if shipping, prohibits drugs being reimported in US, state licensing of wholesalers
  • Starter packs are not considered samples and can be given to pharmacist
  • Retail pharmacist CANNOT possess samples from any source
    o Hospitals can if they maintain precise records
  • Hospitals cannot resell stock
A

Prescription Drug Marketing Act of 1987

65
Q
  • Thalomid
    o Prescriber has to be certified
    o Must counsel patient and provide contraception
    o Verify negative pregnancy test
    o Complete patient-physician agreement form
    o No more than 4 week supply
    o Send to certified pharmacy
A

REMS- Risk Evaluation and Mitigation Services

66
Q

Unit Dose Labeling

A
  • Generic name and trade name
  • Quantity of active drug
  • Name of manufacturer, distributor, or packer
  • Lot number
  • Expiration date
67
Q

Customized patient med packs

BUD?

A
  • BUD of 60 days
68
Q

Form FDA 3500 – Med Watch Form, 3500A is for IND researchers

A
  • Vaccines should go to VAERs
69
Q

Drug Recalls

A
  • Class I: serous ADR, pharmacy stock and require notification to patients
  • Class II: temporary, pharmacy stock
  • Class III: unlikely to cause ADRs
  • Manufacturers responsibility to send written notice
70
Q
  • For prescription or anticipated based on habits
  • Do not sell to third parties
  • Compounded are not commercially available
  • Ingredients are approved by USP
  • Pharmacy cannot solicit but can advertise that they compound
  • Interstate distribution cannot be more than 5% of total prescriptions
  • No requirement to register, but a pharmacy may register as an outsourcing facility
A

Compounded

71
Q

Once prescription has been filled and dispensed, belongs to the pharmacy

A

true

72
Q

Medicare modernization act- keep records for 10 years

A

true

73
Q

Expiration dating established by manufacturer

- Homeopathic products are exempt

A

true

74
Q

Expiration for unit dose/repackaged

- 12 months or 25% of time remaining on the bottle

A

true

75
Q
  • Under control of CPSC (consumer product and safety)
  • Child resistant for the following: ASA, methyl salicylate, controlled substances, prescription drugs, iron (≥250 mg elemental per package), APAP (≥1g), diphenhydramine (66 mg), ibuprofen (≥1g), loperamide, mouth wash (≥3 g of ethanol), lidocaine (5mg), naproxen, ketoprofen, fluoride, minoxidil
  • If OTC is made in multiple sizes, one does not have to be resistant but must contain label that not for household with children
  • All new and refilled rx’s with exemption:
    o Prescriber specifies – only 1 Rx at a time
    o Patient requests
    o Hospitals when drug is being used by health care professionals
A

Poison Prevention Packaging Act

76
Q

What drugs are exempt from Poison Prevention Packaging Act

A

o SL Nitroglycerin
o SL or chewable isosorbide dinitrate 10 mg or less
o Erythromycin ethyl succinate granules for suspension ≤8 mg
o Erythromycin ethyl succinate tablets no more than 16 mg
o Powder cholestyramine
o K supplements in unit dose, less than 50 mEq
o Sodium fluoride less than 264 mg
o Betamethasone in manufacturer
o Methylprednisolone ≥64mg
o Colestipol
o Oral contraceptives
o Pancrealipase

77
Q

Poison Prevention Packaging Act
Testing protocols for children ≤5 and adults 50-70
o Fails if ≥__% of children can open OR if 90% of adults cannot open

A

20%

78
Q

Tamper Evident required for

A

OTC oral

79
Q
  • Required for Accutane, statins, estrogen and progesterin products
  • Applies to physicians and patients in hospitals
  • Can receive within 30 days
  • Must have summary of important info and table
A

Patient Package Inserts

80
Q
  • Language easy to understand by patients
  • Required when: labeling could prevent ADRs, product has serious risks relative to benefits, adherence to directions is crucial
  • Manufacturers must get FDA approval before submitting
A

MedGuides

81
Q
  • Must be similar for ADME
  • Products must show similar time to peak, peak concentrations, and AUC
  • Pharmaceutical alternatives = same therapeutic but may have different salts, esters, dosage forms, or strengths
    o Not allowed, must be equivalent
  • If a product is AB1 can substitute for another AB1, but cannot substitute for AB2
A

Drug Substitution

82
Q
  • Less then 2 fold difference between LD50 and ED50
  • Less than 2-fold difference between minim toxic conc. And minimum effective conc.
  • Most drugs can have limit of 90-110% but NTD must have 95%-105%
    o Carbamazepine, cyclosporine, digoxin, ethosuximide, levothyroxine, lithium, phenytoin, procainamide, tacrolimus, theophylline, warfarin
A

Narrow Therapeutic Drugs

83
Q
  • Manufactueres can mail if they addressee is enrolled with DEA
  • Can mail CS if:
A

o Inner label is packaged and labeled following CS Act
o Place in plain container
o Out wrapper free form markings

84
Q
  • Medicaid Prudent Pharnaceutical Purchase Provisions requires DUR that has a prospective and retrospective component
  • Info required on profile
    o Patient’s name, address, phone
    o Age or DOB
    o Sex
    o Disease state info if known
    o Any allergies
    o List of medications previously dispensed
    o Pharmacists comments when necessary
  • Requires to offer counseling- since under states they decide
    o Federal law does not include what should be discussed
  • Pharmacist does not counsel only when patient refuses
  • Objective to reduce cost of state Medicaid costs
  • Pharmaceutical manufacturers are required to offer Medicaid programs the lowest or best price
A

Obra 90 and Patient Counseling Act

85
Q
  • Assure privacy and security of records
  • Ever provider to submits electronically is a covered entity
  • Fines if broken
  • Medical groups must provide written notice
    o Must be kept for a minimum of 6 years from when service OR last date prescription was dispensed
    o No requirement for future signatures
  • Pharmacies must provide a notice of privacy when patients first start- no expiration
    o Can still provide services if patient refuses
  • Patients can report perceived breakings to HHS/OCR
  • Pharmacies must post notice of privacy in public site as well as website if they have one
A

HIPPA

86
Q 
-	Exportation
o	Shipment of drugs to foreign country
-	Importation
o	Brought in from another country
o	Must be labeling and cGMP standards
-	Reimportation
o	Drug in US shipped to foreign country and then shipped back to US
o	Only legal if the original manufacturer does it
A

International Commerce Involving Drugs

87
Q

Should only purchase drugs from website if it contains VIPPS (Verified internet pharmacy practice)

A

true

88
Q

FDA prohibits shipment of unapproved drugs by interstate shipment

A

true

89
Q

Can be biosimilar with difference in molecular structure

A

true

90
Q

DEA is under supversion of the

A

attorney general

91
Q
  • “enone”, “testosterone” “olone” “estrenol” “ulone” “erone”
A

Anabolic steroid

92
Q
  • Short term is 30 days, long term is 30-180 days
A

Detoxification treatment

93
Q
  • Opium, opiates, derivatives
  • Poppy straw
  • Coca leaves except where cocaine, ecgonine, and salts have been removed
  • Cocaine, salts, iosmers
  • Ecgonine and its derviatives
A

Narcotic drug

94
Q

Registrations of Manufacturers, Disributers, and Dispensers with DEA for CS

A
  • Business activity shall be assigned to month

- Initial registration expires 36 months

95
Q

DEA Registration for Applicants

A
  • Pharmacies – DEA form 224
  • Manufacturers, disributors, importers, exporters, or researchers – form 225
  • Narcotic treatment Programs – Form 363
  • Registration forms are sent 60 days before expiring
96
Q

Schedule 1 drugs

A
  • Bufotenine
  • Diethylyamide
  • Heroin
  • Lysergic acid
  • Marijuana
  • Mescaline
  • Methaquinolone
  • Peyote
97
Q

Purchasing or transferring a CI or CII – DEA form 222

A
  • Not required when transferring products from central fill to retail pharmacy
  • Only one item on the line
    o Each product must be on a different line
  • Name and address of supplier
  • Signed and dated by person authorized
  • Unused forms must be delivered when any federal, state, or local inspects site
  • Purchaser’s name must be on form, even if it is one of the power of atterny completing the form
  • Purchaser submits copy 1 and 2 and retains copy 3
    o Must record on copy 3 cotainers received and dates
  • If an order cannot be completely filled it may be partially and balance is owed within 60 days
  • Supplier retains copy 1 and forward copy 2 to DEA
  • Copy 1- brown, supplier
  • Cop 2- green- supplier forwards to DEA
  • Copy 3- blue retained by purchaser
  • Keep records for 2 years
98
Q

Endorsing an Order

A
  • Supplier who cannot fill all or part within specified time may be ednored to another supplier
  • Can only be made by supplier to whom order was frist made
    o Name and address of second supplier
    o Signature of person authorized on behalf of first supplier
  • 1st supplier cannot fil any part of the order
99
Q

Lost forms

A
  • Statement with serial numbers

- Immediately report to special agent charge of DEA

100
Q

Controlled Substance Ordering Systems (CSOS)

A
  • Electronic DEA form 222
  • Allowed once for Schedule I and 2, can also use for schedule iii-v
  • Paper has limit of 10 items per form, this has no limit
  • Faster trasnactions and smaller inventories
  • Accurate orders
  • Decreased cost
  • Can include non controlled
101
Q

If compounding CS must register as a manufacturer except

A
  • Compounded as aqeous, oligenous, or solid form
  • Does not contain more than 20% of CS
  • Only distributed to a practitioner who is authorized to dispense
102
Q

Control substances – need DEA when writing

A

Auditor must approve application for DEA and writing CS

103
Q

Need 2 factor identity proofing to sign for electronic CS:

A

something you know, something you have, something you are

104
Q

Detoxification and maintenance programs

A
  • To DISPENSE must register separate with DEA
  • Without license, physician can administer for withdrawal why they are waiting for a recovery program
    o Only one day at a time
    o Not more than 3 days
105
Q

Central fill pharmacies CANNOT fill emergency oral CS II drugs

A

true

106
Q

faxing of CII

A
  • LTCF
  • Home infusion for parenteral administration
  • Hospice
107
Q

Contol substances– “caution, federal use prohibits transfer of drug to any other person”

A

true

108
Q
  • Transimitted electronically or fax
  • Write CENTRAL FILL on original and record name, address, DEA of cnetra lfill and name of pharmacist and date of transmission
  • Indicate # of refills
  • Maintain original from 2 years from date it was last refilled
A

Retail and central fill pharmacies for Schedule 3-5

109
Q

Disposal of Controlled Substances

A
  • Reverse distributer
  • DEA form 222
  • Schedule 3-5
    o Maintain dosage form, strength, quantity, and date
  • Reverse distributer will destroy, and reverse distributor will fill out DEA FORM 41
110
Q

Pharmacists may transfer up to 5% total dosage units of controlled substances in a calendar year

A
  • If more, need wholesaler license

- Use DEA form 222 for Controls 1-2 when transferring

111
Q

If pharmacy goes out of business OR gets a new owner

A
  • Use DEA form 222 for transferring
  • Schedule 3-5 also must be documented with name, strength, dosage form, quantity, date transferred, and DEA
  • If going out of buissness and going to another pharmacy
    o Must do inventory that day
    o Will serve as final inventory
    o Both parties need records
    o Do not need to send copy to DEA
112
Q

Physicians are not required to keep records of CS unless its for a detox program, written in their practice, or regularly dispense
Mid level need to keep records for DEA

A

true

113
Q

Pharmacies when organizing scripts keep CSII sepearte, then c3-5, then non controlled

A
  • Need red C for Schedule 1 or 2 if records are not maintained by electronic system
114
Q

theft

A
  • Notify DEA immediately
  • Complete DEA form 106
  • Breakage, damage, or spill report to DEA form 41
115
Q

Mailorder limited to 7.5g/30 days of PSE

all non-liquid PSE must be packaged in blister packs

A

true

116
Q

Drug Addiction Treatment Act -DATA

A
  • Dispense qualified CS 3-5 drugs to pharmacy

- Can treat 30 in first year, then 100 if apply

117
Q

Opioid Treatment Programs

use what meds

A
  • Methadone, buprenorphine, naltrexone,
118
Q

Prevention of drug diversion

- Can receive ____ dose for days clinic is closed

A

single

119
Q

OTC drug facts

A
  • Active ingredient and amount
  • Uses
  • Warnings
  • Inactive ingredients
  • Purpose
  • Directions: 1) age 2) how much 3) how often and how long
120
Q

Need OTC warning for pregnancy and nursing

A

true

121
Q

OTC require to include sodium content if amount exceeds ___mg/dose

- very low sodium: 35 mg or less
- low sodium :140 mg
A

5mg

122
Q 
OTC labeling requirements for electrolytes
-	Calcium: 
-	Mg: 
-	K: 
-	Warnings of on electrolyte diet and exceed
o	Na: 
o	Ca: 
o	Mg:
o	K:
A
  • Calcium: 20mg
  • Mg: 8 mg
  • K: 5mg
  • Warnings of on electrolyte diet and exceed
    o Na: 140
    o Ca: 3.2 g
    o Mg: 600
    o K: 975
123
Q

OTC tamper except

A
  • Aersol
  • Lozenges and drugs in first aid kits
  • 2-piece gelatin capsules sealed using tamper-evident technology with one tamper-evident feature
124
Q

Medicaid Tamper-Resistant Rx Requirement

A
  • Prevent unauthorized copying
  • Prevent modification
  • Prevent counterfeit rx forms
  • Does not apple to DME
125
Q

Prescription to OTC Reclassification

A
  • NDA requesting OTC to FDA
  • Must not require prescription only status to protect the public
  • May recommend an ingredient be removed/changed
  • Category 1: safe
  • Category 2: not safe
  • Category 3: insufficient evidence
126
Q

Dietary supplement health education act (DSHEA)

A
  • Herbals, amino acids, vitamins, minerals, and supplements
  • Products do not have to prove efficacy
  • Products currently on market to have to prove safe
  • Dietary supplement = final ingredient
127
Q

Herbal labeling

A
  • Include common name, latin name is optional

- Cannot make claims or statements

128
Q

food products including dietary supplements, herbals, and process foods that provide health or health benefits including prevention or treatment of disease

A

Nutraceuticals

129
Q
  • Do not need cGMPs but need to manufactured in sanitary conditions
  • Labeling and advertising by FTC
  • Ingredients need to be in USP/NF or CTFA Cosmetic Ingredient Dictionary
A

Cosmetics

130
Q
  • Used for compounding by using Form ATF-11
  • Cannot be sold or loaned
  • May not be sold to outpatients, store in lock
  • Physicians can write order
A

Alcohol

131
Q

Specially Denatured Alcohol

A
  • Tax exempt

- Unsuitable for beverage

132
Q

Americans with Disabilities Act

A
  • Prevents discrimination if can preform functions of a job

- Any company with 15 or more are covered

Fl 2* (9 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions