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Wholesaler Licensing

All drug wholesalers must be licensed under state licensing requiremnets, which must in turn meet the FDA guidelines under State Licensing of Wholesale Prescription Drug Distributors (21 CFR Part 205). The regulations set forth minimum requirements for prescription drug storage (21 CFR Part 205. 50 [a] and [c]) and security (21 CFR Part 205. 50 [b]), as well as for the treatment of returned, damaged, and outdated prescription drugs (21 CFR Part 205. 50 [e]). Further, wholesale drug distributors must establish and maintain inventories and records of all transactions regarding the receipt and distribution of prescription drugs and make these available for inspection and copying by authorized federal, state, and local law enforcement officials (21 CFR Part 205. 50 [f]).

In most states, wholesale distributor licenses are issued by the state boards of pharmacy and require periodic renewal. The majority of states also require out-of-state wholesaler licences for those out-of-state wholesalers that distribute drugs within their borders. Table 1 presents the available data on wholesale distributor licensure fees and license renewal schedules.

STATE
PERMIT FEE
CONTROLLED SUBSTANCE FEE
LICENSE RENEWAL SCHEDULE (YEARS)
STATE
PERMIT FEE
CONTROLLED SUBSTANCE FEE
LICENSE RENEWAL SCHEDULE (YEARS)
AL
$500
$600
1
MT
$400
$100
1
AK
N/A
N/A
2
NE
$550
N/A
1
AZ
$500
N/A
2
NV
$500
N/A
2
AR
$300
N/A
1
NH
$250
N/A
1
CA
$600
N/A
1
NJ
$200
N/A
N/A
CO
$450
N/A
1
NM
$700
N/A
1
CT
$190
$185
1
NY
$825
N/A
3
DE
$580
$200
2
NC
$500
N/A
1
FL
$800
N/A
2
ND
$200
N/A
1
GA
$700
N/A
2
OH
$150
$37.50
1
HI
N/A
N/A
2
OK
$400
N/A
1
ID
$130
$100
1
OR
$400
$100
1
IL
$200
$50
2
PA
$100
N/A
1
IN
$100
N/A
2
RI
$170
$70
1
IA
$300
N/A
1
SC
$500
N/A
1
KS
$300
N/A
1
SD
$200
$75
1
KY
$100
N/A
1
TN
$408
$40
Cyclical
LA
$200
N/A
1
TX
SCALED
N/A
1
ME
$200
N/A
1
UT
N/A
N/A
2
MD
$1750
N/A
1
VT
$600
N/A
2
MA
$900
N/A
1
VA
$270
$90
1
MI
$85
$85
2
WA
$590
N/A
1
MN
$220
N/A
1
WV
$750
N/A
1
MS
$500
N/A
2
WI
$75
N/A
2
MO
$300
N/A
1
WY
$250
N/A
1

Fees subject to change.



RxLS
P.O. Box 220091
Newhall, CA 91322-0091
E -mail: sales@licenseprotection.com
Phone: +1-800-585-8242
Fax: +1-800-585-8242