856 IAC 3 — ARTICLE 3. WHOLESALE LEGEND DRUGS

ARTICLE 3. WHOLESALE LEGEND DRUGS

Rule 1

856 IAC 3-1-1 856 IAC 3-1-1 Definitions

Rule 1. Definitions

856 IAC 3-1-1 Definitions

Authority: IC 25-26-14-13

Affected: IC 25-26-14

Sec. 1. All terms which are defined in IC 25-26-14 shall have the same meanings as they are so defined when used in this article.

(Indiana Board of Pharmacy; 856 IAC 3-1-1; filed Jun 26, 1992, 5:00 p.m.: 15 IR 2460; readopted filed Jun 12, 2001, 2:17 p.m.: 24 IR 3823; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR-856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 3-1-2 856 IAC 3-1-2 "Chain drug warehouse" defined

856 IAC 3-1-2 "Chain drug warehouse" defined

Authority: IC 25-26-14-13

Affected: IC 25-26-14

Sec. 2. As used in IC 25-26-14 and in this article, "chain drug warehouse" means a permanent physical location for drugs or devices, or both, that:

(1) is licensed as a wholesale distributor;

(2) acts as a central warehouse; and

(3) primarily performs intracompany sales and transfers of legend drugs or devices to chain pharmacies that are members of the same affiliated group under common ownership and control.

(Indiana Board of Pharmacy; 856 IAC 3-1-2; filed Mar 10, 2006, 8:37 a.m.: 29 IR 2195; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR-856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 3-1-3 856 IAC 3-1-3 "Statement" defined

856 IAC 3-1-3 "Statement" defined

Authority: IC 25-26-14-13

Affected: IC 25-26-14

Sec. 3. "Statement" means the specific unit of the specific legend drug that was purchased directly from the manufacturer.

(Indiana Board of Pharmacy; 856 IAC 3-1-3; filed Mar 10, 2006, 8:37 a.m.: 29 IR 2196; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR-856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

Rule 2

856 IAC 3-2-1 856 IAC 3-2-1 Persons required to register (Repealed)

Rule 2. Licensing and Operational Requirements

856 IAC 3-2-1 Persons required to register (Repealed)

(Repealed by Indiana Board of Pharmacy; filed Mar 10, 2006, 8:37 a.m.: 29 IR 2198)

856 IAC 3-2-2 856 IAC 3-2-2 Fees

856 IAC 3-2-2 Fees

Authority: IC 25-26-14-13

Affected: IC 25-26-14-14

Sec. 2. (a) The fee for original licensure and biennial renewal shall be one hundred dollars ($100) for in-state applicants. The fee for original licensure and biennial renewal shall be one hundred dollars ($100) for out-of-state applicants.

(b) Licensure fees shall be paid at the time when the application for licensure or renewal of a license is filed.

(Indiana Board of Pharmacy; 856 IAC 3-2-2; filed Jun 26, 1992, 5:00 p.m.: 15 IR 2461; errata filed Aug 24, 1992, 9:00 a.m.: 16 IR 66; filed Jun 6, 1996, 9:00 a.m.: 19 IR 3107; readopted filed Oct 17, 2001, 3:30 p.m.: 25 IR 941; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR-856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 3-2-3 856 IAC 3-2-3 Application forms; renewal forms

856 IAC 3-2-3 Application forms; renewal forms

Authority: IC 25-26-14-13

Affected: IC 25-26-14-14

Sec. 3. (a) Applications for licensure may be obtained by writing to the Indiana Board of Pharmacy, Indiana Professional Licensing Agency, 402 West Washington Street, Room W072, Indianapolis, Indiana 46204.

(b) Wholesale drug distributor licenses shall expire on September 30 of each even-numbered year. Applications for renewal shall be mailed to the licensee.

(Indiana Board of Pharmacy; 856 IAC 3-2-3; filed Jun 26, 1992, 5:00 p.m.: 15 IR 2461; errata filed Aug 24, 1992, 9:00 a.m.: 16 IR 66; readopted filed Jun 12, 2001, 2:17 p.m.: 24 IR 3823; filed Mar 10, 2006, 8:37 a.m.: 29 IR 2196; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR-856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 3-2-4 856 IAC 3-2-4 Inspection and review of application

856 IAC 3-2-4 Inspection and review of application

Authority: IC 25-26-14-13

Affected: IC 25-26-14-17; IC 25-26-14-19

Sec. 4. The board may inspect, or cause to be inspected, the establishment of an applicant or licensee pursuant to IC 25-26-14-19. The board shall review the application for licensure and other information regarding an applicant to determine whether the applicable standards of IC 25-26-14-17 have been met by the applicant.

(Indiana Board of Pharmacy; 856 IAC 3-2-4; filed Jun 26, 1992, 5:00 p.m.: 15 IR 2461; readopted filed Jun 12, 2001, 2:17 p.m.: 24 IR 3823; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR-856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 3-2-5 856 IAC 3-2-5 Wholesale drug distributor license

856 IAC 3-2-5 Wholesale drug distributor license

Authority: IC 25-26-14-13

Affected: IC 25-26-14

Sec. 5. (a) The board shall issue a wholesale drug distributor license to applicants that qualify under IC 25-26-14.

(b) The wholesale drug distributor license shall contain the name, address, and license number of the licensee, the amount of fee paid, and the expiration date of the license. The licensee shall maintain the wholesale drug distributor license in a readily retrievable manner and shall permit inspection of the license by any official, agent, or employee of the board.

(Indiana Board of Pharmacy; 856 IAC 3-2-5; filed Jun 26, 1992, 5:00 p.m.: 15 IR 2461; readopted filed Jun 12, 2001, 2:17 p.m.: 24 IR 3823; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR-856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 3-2-6 856 IAC 3-2-6 Termination of licensure; transfer of license

856 IAC 3-2-6 Termination of licensure; transfer of license

Authority: IC 25-26-14-13

Affected: IC 25-26-14-14; IC 25-26-14-15

Sec. 6. (a) The license of any person shall terminate if and when such person dies or ceases legal existence. Any licensee who ceases legal existence or discontinues business shall notify the board within ten (10) days of such fact in writing.

(b) No license or any authority conferred thereby shall be assigned or otherwise transferred except to the extent allowed by IC 25-26-14-15, and then only pursuant to the written consent of the board.

(Indiana Board of Pharmacy; 856 IAC 3-2-6; filed Jun 26, 1992, 5:00 p.m.: 15 IR 2461; readopted filed Jun 12, 2001, 2:17 p.m.: 24 IR 3823; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR-856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 3-2-7 856 IAC 3-2-7 Reciprocity (Repealed)

856 IAC 3-2-7 Reciprocity (Repealed)

(Repealed by Indiana Board of Pharmacy; filed Mar 10, 2006, 8:37 a.m.: 29 IR 2198)

856 IAC 3-2-8 856 IAC 3-2-8 Minimum conditions for licensure, renewal, and operations (Repealed)

856 IAC 3-2-8 Minimum conditions for licensure, renewal, and operations (Repealed)

(Repealed by Indiana Board of Pharmacy; filed Mar 10, 2006, 8:37 a.m.: 29 IR 2198)

Rule 3

856 IAC 3-3-1 856 IAC 3-3-1 Board-approved accreditation body

Rule 3. Accreditation

856 IAC 3-3-1 Board-approved accreditation body

Authority: IC 25-26-14-13; IC 25-26-14-14

Affected: IC 25-26-14-14

Sec. 1. The National Association of Boards of Pharmacy's Verified-Accredited Wholesale Distributors (VAWD) program shall do the following:

(1) Evaluate a wholesale drug distributor's operations to determine compliance with the following:

(A) Industry standards.

(B) IC 25-26-14.

(C) This title.

(D) Any other applicable law.

(2) Perform inspections of each facility and location where wholesale distribution operations are conducted by the wholesale drug distributor.

(3) Ensure that the information obtained during accreditation remains confidential and privileged.

(4) Adhere to other requirements set by the board or the Indiana professional licensing agency.

(Indiana Board of Pharmacy; 856 IAC 3-3-1; filed Mar 10, 2006, 8:37 a.m.: 29 IR 2196; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR-856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 3-3-2 856 IAC 3-3-2 Accreditation for new applicants

856 IAC 3-3-2 Accreditation for new applicants

Authority: IC 25-26-14-13

Affected: IC 25-26-14-14

Sec. 2. For licenses issued after December 31, 2005, applicants for licensure as wholesale drug distributors shall obtain the accreditation from the National Association of Boards of Pharmacy's Verified-Accredited Wholesale Distributors (VAWD) program before issuance of licensure.

(Indiana Board of Pharmacy; 856 IAC 3-3-2; filed Mar 10, 2006, 8:37 a.m.: 29 IR 2196; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR-856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 3-3-3 856 IAC 3-3-3 Accreditation for existing license holders

856 IAC 3-3-3 Accreditation for existing license holders

Authority: IC 25-26-14-13

Affected: IC 25-26-14-14

Sec. 3. For licenses issued before January 1, 2006, license holders shall obtain the accreditation from the National Association of Boards of Pharmacy's Verified-Accredited Wholesale Distributors (VAWD) program before renewal of licensure on September 30, 2006.

(Indiana Board of Pharmacy; 856 IAC 3-3-3; filed Mar 10, 2006, 8:37 a.m.: 29 IR 2196; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR-856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 3-4 Rule 4. Pedigrees (Expired)

Rule 4. Pedigrees (Expired)

(Expired under IC 4-22-2.5, effective January 1, 2019.)

Rule 5

856 IAC 3-5-1 856 IAC 3-5-1 Authorized distributor to authorized distributor transaction; pedigree requirement (Expired)

Rule 5. Normal Distribution Chain of Custody

856 IAC 3-5-1 Authorized distributor to authorized distributor transaction; pedigree requirement (Expired)

Sec. 1.

(Expired under IC 4-22-2.5, effective January 1, 2019.)

856 IAC 3-5-2 856 IAC 3-5-2 Chain drug warehouses in the normal distribution chain of custody (Expired)

856 IAC 3-5-2 Chain drug warehouses in the normal distribution chain of custody (Expired)

Sec. 2.

(Expired under IC 4-22-2.5, effective January 1, 2019.)

856 IAC 3-5-3 856 IAC 3-5-3 Entities within the normal distribution chain custody

856 IAC 3-5-3 Entities within the normal distribution chain custody

Authority: IC 25-26-14-8.5; IC 25-26-14-13

Affected: IC 25-26-14-17

Sec. 3. All entities, other than manufacturers approved by the Food and Drug Administration, within the normal distribution chain of custody shall be located and licensed within the United States or its territories.

(Indiana Board of Pharmacy; 856 IAC 3-5-3; filed Mar 10, 2006, 8:37 a.m.: 29 IR 2197; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR-856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 3-5-4 856 IAC 3-5-4 Applicability of normal distribution chain of custody (Expired)

856 IAC 3-5-4 Applicability of normal distribution chain of custody (Expired)

Sec. 4.

(Expired under IC 4-22-2.5, effective January 1, 2019.)

856 IAC 3-6 Rule 6. Drug Returns (Expired)

Rule 6. Drug Returns (Expired)

(Expired under IC 4-22-2.5, effective January 1, 2019.)

Rule 7

856 IAC 3-7-1 856 IAC 3-7-1 Authentication

Rule 7. Authentications

856 IAC 3-7-1 Authentication

Authority: IC 25-26-14-13

Affected: IC 25-26-14

Sec. 1. Manufacturers shall cooperate in the process of authentication, as defined in IC 25-26-14.

(Indiana Board of Pharmacy; 856 IAC 3-7-1; filed Mar 10, 2006, 8:37 a.m.: 29 IR 2197; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR-856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)