L8: Compounding

Question 1

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)

Answer 1

brand name drug

Question 2

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

Answer 2

Generic Drug

Question 3

“traditional” compounding performed by veterinarians and compounding pharmacies

Answer 3

503A compounding

Question 4

compounding performed only by special outsourcing facilities

Answer 4

503B compounding

Question 5

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

Answer 5

compounding

Question 6

what can be used for compounding

Answer 6

FDA approved trade-name and generic drugs
considered ELDU

Question 7

who can compound

Answer 7

vet or pharmacist under the prescription of a vet

Question 8

when to compound

Answer 8

to meet the needs of an individual patient

Question 9

who can you compound for

Answer 9

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

Question 10

are compound drugs equivalent to generic drugs

Answer 10

no

Question 11

are compounded drugs FDA approved medications

Answer 11

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

Question 12

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

Answer 12

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

Question 13

reasons for compounding

Answer 13

• 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

Question 14

FDA estimates vets write _____ prescriptions for compounded drugs each year

Answer 14

6.3 million

Question 15

compounding example
what is the benefit of using Buprenorphine ER

Answer 15

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

Question 16

who regulates compounding

Answer 16

• 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

Question 17

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

Answer 17

“new drug”
“new animal drug”
AMDUCA exception

Question 18

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

Answer 18

AMDUCA 1994

Question 19

T/F: compounding is considered ELDU

Answer 19

TRUE

Question 20

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….?

Answer 20

ELDU

Question 21

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

Answer 21

ELDU

Question 22

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

Answer 22

ELDU

Question 23

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

Answer 23

ELDU

Question 24

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

Answer 24

ELDU

Question 25

when might vets need bulk drug compounding

Answer 25

* 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

Question 26

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

Answer 26

non-patient-specific

Question 27

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

Answer 27

FDA

Question 28

outsourcing facilities MUST (3 things)

Answer 28

* comply with CGMP requirements * report adverse events * provide FDA with certain info about the products they compound

Question 29

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

Answer 29

Current Good Manufacturing Practice (CGMP)

Question 30

what are 3 important FDA regulation acts

Answer 30

* FDCA * AMDUCA (animal medicinal drug use clarification act, 1994) * DQSA (drug quality safety act, 2013)

Question 31

what is the reason for compounding ponazuril + pyrantel pamoate

Answer 31

makes it easier to administer multiple meds

Question 32

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

Answer 32

new

Question 33

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

Answer 33

new animal drugs

Question 34

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

Answer 34

adultered

Question 35

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

Answer 35

misbranded drugs and devices

Question 36

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

Answer 36

**products that are being sold for administration** secondary focus: the need for documentation on patient specific scripts

Question 37

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

Answer 37

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

Question 38

why FDA approved drugs are slay

Answer 38

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

Question 39

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

Answer 39

**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

Question 40

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

Answer 40

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

Question 41

in food animals, compounding is used when?

Answer 41

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

Question 42

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

Answer 42

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

Question 43

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...?

Answer 43

aqeous vehicles

Question 44

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?

Answer 44

naur

Question 45

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

Answer 45

**bioavailability or stability**

Question 46

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

Answer 46

25%

Question 47

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

Answer 47

14