Who Needs a Wholesale Drug Distributor License
For more information regarding the statutes and rules regulating wholesale drug distributors, please review them below.
For legal interpretations, please refer to your legal counsel; the Board office does not interpret the rules and regulations.
Any individual, partnership, limited liability company, corporation or business firm located in or outside Indiana and is physically distributing legend drugs into or within the state of Indiana is required to hold an Indiana wholesale drug distributor license as well as have obtained the Verified Accredited Wholesale Distributors (VAWD) accreditation.
Indiana law requires wholesale drug distributors of legend drugs to obtain and maintain VAWD accreditation from the National Association of Boards of Pharmacy (NABP). For more information regarding VAWD, including the accreditation process, VAWD application form, and instructions, please visit NABP's website at http://www.nabp.net/programs/accreditation/vawd/.
Exceptions to Licensure
The following entities are not required to obtain licensure, VAWD, or comply with the requirements of IC 25-26-14:
- FDA approved manufacturers (who distribute their own manufactured products);
- medical gas manufacturers or distributors that manufacture or distribute medical gases only; and
- veterinary supply distributors that distribute legend drugs that are FDA approved for animal use only.
- Wholesale Drug Distributor Defined
"Wholesale drug distributor" means a person engaged in wholesale drug distribution of legend drugs, including:
- own-label distributors;
- warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses;
- independent wholesale drug traders;
- retail and hospital pharmacies that conduct wholesale distributions; and
- reverse distributors.
This term does not include a common carrier or person hired solely to transport prescription drugs.
Legend Drug Defined
"Legend drug" means a drug that is subject to 21 USC 353(b)(1) or is listed in the Prescription Drug Product List published in the US Department of Health and Human Services Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. The term includes any human drug required by federal law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to 21 USC 811 through 812. The term does not include a device or a device component, part, or accessory.
Wholesale Distribution Defined
"Wholesale distribution" means to distribute legend drugs to persons other than a consumer or patient.
The term does not include:
- a sale or transfer between a division, a subsidiary, a parent, an affiliated, or a related company under the common ownership and control of a corporate entity;
- the purchase or acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug for the hospital's or health care entity's own use from the group purchasing organization or from other hospitals or health care entities that are members of the organization;
- the sale of a drug by a charitable organization described in Section 501(c)(3) of the Internal Revenue Code, to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
- the sale of a drug among hospitals or other health care entities that are under common control;
- the sale of a drug for emergency medical reasons, including transfers of legend drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage, if the gross dollar value of the transfers does not exceed five percent (5%) of the total legend drug sales revenue of either the transferor or transferee pharmacy during any twelve (12) consecutive month period;
- the sale of a drug or the dispensing of a drug pursuant to a prescription;
- the distribution of drug samples by manufacturers' representatives or distributors' representatives;
- the sale of blood and blood components intended for transfusion;
- the sale of a drug by a retail pharmacy to a practitioner (as defined in IC 25-26-13-2) for office use, if the gross dollar value of the transfers does not exceed five percent (5%) of the retail pharmacy's total legend drug sales during any twelve (12) consecutive months;
- the sale of a drug by a retail pharmacy that is ending its business and liquidating its inventory to another retail pharmacy;
- drug returns by a hospital, health care entity, or charitable institution conducted under 21 CFR 203.23;
- the sale of minimal quantities of drugs by retail pharmacies to licensed practitioners for office use;
- the distribution of prescription drugs by the original manufacturer of the finished form of the prescription drug or the distribution of the co-licensed products by a partner of the original manufacturer of the finished form of the prescription drug; or
- drug returns that meet criteria established by rules adopted by the board.
If you have additional questions, please e-mail our office at pla4@pla.IN.gov.