Location:
PHARMACIES AND PHARMACISTS; DRUGS;

OLR Research Report


April 10, 2003

 

2003-R-0377

LICENSING WHOLESALE PHARMACEUTICAL COMPANIES

By: Jerome Harleston, Senior Attorney

You asked if any state has considered licensing entities engaged in the wholesale pharmaceutical business to ensure that as drugs are transported to market they are not subjected to conditions that render them ineffective.

All drug wholesalers must be licensed under state licensing systems, 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Part 205.50 [a] and [c]) and security (21 CFR Part 205.50 [b]), as well as for the treatment of returned, damaged, and outdated prescription drugs (21 CFR Part 205.50 [e]).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 (approximately 80%) also require out-of-state wholesalers that distribute drugs within their borders to be licensed as well. Table 1 presents the available data on wholesale distributor licensure requirements, license renewal schedules, and the number of in-state and out-of-state licenses issued, by state.

Table 1: Pharmaceutical Company Licensing

State Wholesale Distributor Licensure Requirements, Renewal Schedules,
And the Number of In-State and Out-of-State Wholesale Distributor Licenses Issued by State

State

Does State License
Out-of-State Wholesalers?

License Renewal Schedule

Number of
Wholesale Licenses

 

 

 

In-State

Out-of-State

Total

Alabama

Yes

1 year

NA

NA

745

Alaska

No

2 years

9

147

156

Arizona

No[a]

2 years

15

185

200[e]

Arkansas

Yes

1 year

NA

NA

495

California

Yes

1 year

427

276

703

Colorado

Yes[b]

1 year

NA

NA

282

Connecticut

Yes

1 year

NA

NA

362

Delaware

Yes

2 years

32

444

476

District

of Columbia

Yes

1 year

NA

NA

0

Florida

Yes

2 years

530

764

1,294

Georgia

Yes

2 years

NA

NA

644

Hawaii

No[c]

2 years

NA

NA

45

Idaho

Yes

1 year

NA

NA

475[e]

Illinois

Yes

2 years

NA

NA

685

Indiana

Yes

2 years

192

450

642

Iowa

Yes

1 year

NA

NA

579

Kansas

Yes

1 year

NA

NA

526

Kentucky

Yes

1 year

NA

NA

450

Louisiana

Yes

1 year

180

606

786

Maine

Yes

1 year

5

277

282

Maryland

Yes

1 year

NA

NA

1,500[e]

Massachusetts

No

1 year

0

140

140[e]

Michigan

Yes

2 years

NA

NA

580

Minnesota

Yes

1 year

NA

NA

352

Mississippi

Yes

2 years

NA

NA

726

Missouri

Yes

1 year

NA

NA

780

State

Does State License
Out-of-State Wholesalers?

License Renewal Schedule

Number of
Wholesale Licenses

State

Does State License
Out-of-State Wholesalers?

Montana

Yes

1 year

NA

NA

298

Nebraska

No

1 year

NA

NA

61

Nevada

Yes

2 years

83

340

423

New Hampshire

Yes

1 year

8

493

501

New Jersey

No

NA

NA

NA

1,000[e]

New Mexico

Yes

1 year

NA

NA

482

New York

No

3 years

349

0

349

North Carolina

Yes

1 year

154

251

405

North Dakota

Yes

1 year

6

450

456

Ohio

Yes

1 year

491

599

1,090

Oklahoma

Yes

1 year

34

335

369

Oregon

Yes

1 year

825

325

1,150

Pennsylvania

NA [d]

1 year

525

0

525

Rhode Island

Yes

1 year

48

210

258

South Carolina

No

1 year

NA

NA

419

South Dakota

Yes

1 year

29

382

411

Tennessee

Yes

Cyclical

350

518

868

Texas

Yes [d]

1 year

1,832

604

2,436[f]

Utah

No

2 years

52

0

52

Vermont

Yes

2 years

3

311

314

Virginia

Yes

1 year

238

432

670

Washington

Yes

1 year

72

301

373

West Virginia

Yes

1 year

NA

NA

412

Wisconsin

Yes

2 years

194

314

508

Wyoming

Yes

1 year

50

431

481

Total

NA

NA

6,733

9,585

28,216[g]

Source: NABP, 1999, PDA, 2000a, and Texas Department of Health, 2001
"NA" = Not available
[a] Will begin licensing (permitting) non-resident wholesale drug distributors in the year 2000 pursuant tomethamphetamine legislation requirement.
[b] For controlled substances only.
[c] However, per Board's informal interpretation, if the out-of-state wholesaler has a vendor-managed inventory system within the State, a wholesale distributor license is required.
[d] Wholesalers are regulated and licensed by Department of Health.
[e] Indicates that the figure is approximate.


[f] The figure represents the number of wholesale distributor licenses that are current as of January 17, 2001 (Texas Department of Health, 2001).
[g] The figure represents the total number of licenses for wholesale operation. Multi-state wholesalers presumably hold licenses in all states where they operate and are required. The total number of licenses does not represent an estimate of the number of unique wholesalers.

 

JH:eh