Product Comparison Chart - Animal Drug
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1Product Comparison Chart
Requirements
New Animal
Generic Animal
Compounded
Drug (Pioneer
Drug
Drug
product)
FDA Approval Required YES
YES
NO
Drugs tested to prove
YES
YES
NO
Safety and Efficacy
Drugs manufactured
YES
YES
NO
under current Good
Manufacturing
Practices (cGMP’s)
Manufacturing facilities
YES
YES
NO
inspected and approved
by FDA
Conduct on-going
YES
YES
NO
stability testing of drugs
Labels approved by
YES
YES
NO
FDA
Advertising/Promotional
YES
YES
NO
material reviewed by
FDA
Adverse Events/Lack of
YES
YES
NO
Efficacy reported to
FDA
Drug Manufacturer
YES
YES
NO
Facilities inspected by
FDA
Analytical Testing of
Product Prior to Release
for:
Strength
YES
YES
NO
Identity
YES
YES
NO
Purity
YES
YES
NO
Potency
YES
YES
NO
Sterility (if applicable)
YES
YES
Possibly
1
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Parent category: Business