Attachment A

DRUG FORMULARY COMMISSION

Required Data and Optional Information to be Submitted with Petitions*

ORDER	CRITERION	REQUIREMENT	
A	Name of reference drug	y
	
B	Federal regulatory status
(B coded, pre-38, DESI)
	y	
C	FDA observational inspection (Form 482) for manufacturer
	y	
D	FDA inspection report for laboratory performing certifications (assays or analysis)
	y	
E	Special FDA requirements if any
	y
(if applicable)
	
F	Meets USP standards	y
	
G	Assay of active ingredients for petitioner and reference products
	y
	
H	Comparison of dissolution profiles - Certificate of analysis
	y
	
I	Comparison of bioavailability with reference product	y
(if extended-release)
	
J	Data on clinical and therapeutic comparability	y
(if narrow therapeutic index1 and bioequivalence not essential2)
	
K	Bioequivalence data	y
(if bioequivalence essential2)
	
L	Significant new information	y
(if petition previously voted upon)
	
M	Formularies of other states or hospitals
	optional
	
N	Other supporting information
	optional	

1 Requires careful patient titration and monitoring for safe and effective use.
2 As determined by the Drug Formulary Commission.

*Petitions for multivitamin prescription products should follow criteria approved November 17, 1998 (Attachment B).