L8: Compounding Flashcards
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)
brand name drug
a bioequivalent version of a drug licensed after patent protection for a brand-name drug expires
and is approved by the FDA
Generic Drug
“traditional” compounding performed by veterinarians and compounding pharmacies
503A compounding
compounding performed only by special outsourcing facilities
503B compounding
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
compounding
what can be used for compounding
FDA approved trade-name and generic drugs
considered ELDU
who can compound
vet or pharmacist under the prescription of a vet
when to compound
to meet the needs of an individual patient
who can you compound for
Patients within a valid Veterinarian-Client-Patient Relationship (VCPR)
means vet knows pet well enough to diagnose and treat medical conditions
are compound drugs equivalent to generic drugs
no
are compounded drugs FDA approved medications
NO, even though formulated from an FDA approved drug
this is because that are NOT tested for:
- efficacy, safety, potency, sterility, dosage, stability
can compounding be used with the goal of making a drug more affordable
no, economics is not a sanctioned reason to choose compounded meds
reasons for compounding
- 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
FDA estimates vets write _____ prescriptions for compounded drugs each year
6.3 million
compounding example
what is the benefit of using Buprenorphine ER
provides 72 hours of pain control
allows for long lasting pain control without dispensing opioids
who regulates compounding
- 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
All compounded drugs are subject to the FDCA’s _____ and ______definitions and approval requirements unless they fall under an ________
“new drug”
“new animal drug”
AMDUCA exception
what act permits vets to prescribe extralabel uses of certain approved drugs and approved human drugs for animals under certain conditions
AMDUCA 1994
T/F: compounding is considered ELDU
TRUE
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….?
ELDU
use of drug in species not listed in the labeling is considered…
ELDU
Use for indications (disease and other conditions) not listed in the labeling is considered…
ELDU
Use at dosage levels, frequencies, or routes of administration other than those stated in the labeling is considered….
ELDU
Deviation from labeled withdrawal time based on these different uses is considered….
ELDU
when might vets need bulk drug compounding
- 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
Outsourcing facilities may compound and distribute _________
veterinary preparations (“office stock”) using specified bulk drug
substances
non-patient-specific
Outsourcing facilities are inspected by the _____ according to a risk based schedule
FDA
outsourcing facilities MUST (3 things)
- comply with CGMP requirements
- report adverse events
- provide FDA with certain info about the products they compound
what is the Main regulatory standard for ensuring pharmaceutical quality for human pharmaceuticals that is Enforced by FDA
Current Good Manufacturing Practice (CGMP)
what are 3 important FDA regulation acts
- FDCA
- AMDUCA (animal medicinal drug use clarification act, 1994)
- DQSA (drug quality safety act, 2013)
what is the reason for compounding ponazuril + pyrantel pamoate
makes it easier to administer multiple meds
Title 21 of the United States Code (USC) 355: _____drugs
new
Title 21 of the United States Code (USC) 360b: _____drugs
new animal drugs
Title 21 of the United States Code (USC) 351: _____drugs
adultered
Title 21 of the United States Code (USC) 352: _____drugs
misbranded drugs and devices
what is the primary focus of GFI (guidance for industry) #256
products that are being sold for administration
secondary focus: the need for documentation on patient specific scripts
who assumes liability for any adverse effects or efficacy failure of compounded drugs
YOU the prescribing veterinarian
neither drug manufacturers or pharmacies are required to carry product liability insurance
why FDA approved drugs are slay
they limit your liability
*have undergone extensive testing to verify their safety and efficacy
* contents and concentrations are known
* label dosages are proven safe
in what scenario can considering costs play a role in prescribing a drug
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
when is it okay to use an ELDU alternative medicine when an approved animal drug exists for that species/condition
if a vet finds that the approved drug is clinically ineffective for its intended use
in food animals, compounding is used when?
where there is ABSOLUTELY NO OTHER CHOICE for treating that animals medical condiiton
is compounding for food producing animals allowed (according to general industry guidelines) ?
no
but it is legal when done in accordance with 21 CRF530.13
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…?
aqeous vehicles
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?
naur
altering drug producing (compounding) may alter the ________ or the _______ of the product
bioavailability or stability
drugs should not be used later than ___% of the time remaining until the products expiration date
25%
for drugs that have water containing formulations, they should not be used later than ____ days at cold temperature
14
