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PHARMACOLOGY I > L8: Compounding > Flashcards

L8: Compounding Flashcards

1
Q

a drug that has a trade name and is protected by a patent(can be produced and sold only
by the company holding the patent)

A

brand name drug

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2
Q

a bioequivalent version of a drug licensed after patent protection for a brand-name drug expires
and is approved by the FDA

A

Generic Drug

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3
Q

“traditional” compounding performed by veterinarians and compounding pharmacies

A

503A compounding

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4
Q

compounding performed only by special outsourcing facilities

A

503B compounding

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5
Q

the manipulation of FDA approved drugs by a veterinarian or a
pharmacist upon the prescription of a veterinarian to meet the needs of an individual patient that is under his or her care

A

compounding

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6
Q

what can be used for compounding

A

FDA approved trade-name and generic drugs
considered ELDU

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7
Q

who can compound

A

vet or pharmacist under the prescription of a vet

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8
Q

when to compound

A

to meet the needs of an individual patient

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9
Q

who can you compound for

A

Patients within a valid Veterinarian-Client-Patient Relationship (VCPR)
means vet knows pet well enough to diagnose and treat medical conditions

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10
Q

are compound drugs equivalent to generic drugs

A

no

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11
Q

are compounded drugs FDA approved medications

A

NO, even though formulated from an FDA approved drug
this is because that are NOT tested for:
- efficacy, safety, potency, sterility, dosage, stability

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12
Q

can compounding be used with the goal of making a drug more affordable

A

no, economics is not a sanctioned reason to choose compounded meds

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13
Q

reasons for compounding

A
  • there are a limited # of FDA approved drugs for the many species and conditions vet treat (ex: exotics)
  • to make drugs easier to administer (concentration, route, palatability)
  • to make it easier to administer multiple meds
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14
Q

FDA estimates vets write _____ prescriptions for compounded drugs each year

A

6.3 million

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15
Q

compounding example
what is the benefit of using Buprenorphine ER

A

provides 72 hours of pain control
allows for long lasting pain control without dispensing opioids

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16
Q

who regulates compounding

A
  • federal gov through the US FDA
  • state governments
  • state boards of pharmacy have the primary responsibility for the oversight of state licensed pharmacies that compound drugs in accordance w/ the conditions of section 503A of the FDCA
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17
Q

All compounded drugs are subject to the FDCA’s _____ and ______definitions and approval requirements unless they fall under an ________

A

“new drug”
“new animal drug”
AMDUCA exception

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18
Q

what act permits vets to prescribe extralabel uses of certain approved drugs and approved human drugs for animals under certain conditions

A

AMDUCA 1994

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19
Q

T/F: compounding is considered ELDU

A

TRUE

20
Q

Actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling is considered….?

A

ELDU

21
Q

use of drug in species not listed in the labeling is considered…

A

ELDU

22
Q

Use for indications (disease and other conditions) not listed in the labeling is considered…

A

ELDU

23
Q

Use at dosage levels, frequencies, or routes of administration other than those stated in the labeling is considered….

A

ELDU

24
Q

Deviation from labeled withdrawal time based on these different uses is considered….

A

ELDU

25
Q

when might vets need bulk drug compounding

A
  • when a drug previously approved by the FDA is no longer commercially available
  • the meds needed can’t be prepared from an FDA approved drug product
26
Q

Outsourcing facilities may compound and distribute _________
veterinary preparations (“office stock”) using specified bulk drug
substances

A

non-patient-specific

27
Q

Outsourcing facilities are inspected by the _____ according to a risk based schedule

A

FDA

28
Q

outsourcing facilities MUST (3 things)

A
  • comply with CGMP requirements
  • report adverse events
  • provide FDA with certain info about the products they compound
29
Q

what is the Main regulatory standard for ensuring pharmaceutical quality for human pharmaceuticals that is Enforced by FDA

A

Current Good Manufacturing Practice (CGMP)

30
Q

what are 3 important FDA regulation acts

A
  • FDCA
  • AMDUCA (animal medicinal drug use clarification act, 1994)
  • DQSA (drug quality safety act, 2013)
31
Q

what is the reason for compounding ponazuril + pyrantel pamoate

A

makes it easier to administer multiple meds

32
Q

Title 21 of the United States Code (USC) 355: _____drugs

A

new

33
Q

Title 21 of the United States Code (USC) 360b: _____drugs

A

new animal drugs

34
Q

Title 21 of the United States Code (USC) 351: _____drugs

A

adultered

35
Q

Title 21 of the United States Code (USC) 352: _____drugs

A

misbranded drugs and devices

36
Q

what is the primary focus of GFI (guidance for industry) #256

A

products that are being sold for administration

secondary focus: the need for documentation on patient specific scripts

37
Q

who assumes liability for any adverse effects or efficacy failure of compounded drugs

A

YOU the prescribing veterinarian
neither drug manufacturers or pharmacies are required to carry product liability insurance

38
Q

why FDA approved drugs are slay

A

they limit your liability
*have undergone extensive testing to verify their safety and efficacy
* contents and concentrations are known
* label dosages are proven safe

39
Q

in what scenario can considering costs play a role in prescribing a drug

A

in a non-food producing animal, a drug labeled for use in humans can be administered EVEN IF an animal drug for that species and medical condition exists

40
Q

when is it okay to use an ELDU alternative medicine when an approved animal drug exists for that species/condition

A

if a vet finds that the approved drug is clinically ineffective for its intended use

41
Q

in food animals, compounding is used when?

A

where there is ABSOLUTELY NO OTHER CHOICE for treating that animals medical condiiton

42
Q

is compounding for food producing animals allowed (according to general industry guidelines) ?

A

no
but it is legal when done in accordance with 21 CRF530.13

43
Q

if a drug is packaged in blister packs or with a moisture proof barrier, that drug is probably subject to loss of stability and potency if mixed with…?

A

aqeous vehicles

44
Q

if an anitbiotic is available in powder form that has to be reconstituted in a vial or in an oral dispensing bottle prior to administration, should it be mized w/ other drugs?

A

naur

45
Q

altering drug producing (compounding) may alter the ________ or the _______ of the product

A

bioavailability or stability

46
Q

drugs should not be used later than ___% of the time remaining until the products expiration date

A

25%

47
Q

for drugs that have water containing formulations, they should not be used later than ____ days at cold temperature

A

14

PHARMACOLOGY I (21 decks)

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