Tenn. Comp. R. & Regs. 1140-09-.02 - MINIMUM INFORMATION REQUIRED

(1) The board shall require the following minimum information from each manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor applying for a license or any renewal of such license:

(a) The name, full business address, and telephone number of the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor;

(b) All trade or business names used by the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor;

(c) Addresses, telephone numbers, and the names of contact persons for all facilities used by the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor for storage, handling, and distribution;

(d) The type of ownership or operation (i.e., partnership, corporation, or sole proprietorship); and

(e) The name(s) of the owner and/or operator of the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor, including:

1. If a person, the name of the person;

2. If a partnership, the name of each partner, and the name of the partnership;

3. If a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the state of incorporation;

4. If a sole proprietorship, the full name of the sole proprietor and the name of the business entity;

5. DEA registration number if applicable; and

6. The results of a criminal background check for the owner or manager of the facility seeking licensure, submitted directly to the Board of Pharmacy by the vendor identified in the Board of Pharmacy's licensure application materials.

(2) Applicants seeking to register as manufacturers or outsourcing facilities shall provide the following materials to the Board of Pharmacy:

(a) Proof of registration with the Food and Drug Administration as a manufacturer or outsourcing facility and the most current inspection by that agency, or correspondence or other written proof from the Food and Drug Administration which states that registration with that agency is unnecessary;

(b) The name and contact information of the owner, the owner's agent, or another such individual employed at or contracted by the applicant that can be reached at any time by the Board of Pharmacy, the Department of Health or any agents thereof in the event of a potential or actual public health threat related to the sterility or potency of any drug or biologic product manufactured, wholesaled or distributed by the applicant.

(3) Applicants seeking to obtain a sterile compounding modifier registration shall provide the following materials to the Board of Pharmacy:

(a) Upon request by the Board of Pharmacy or the executive director, a list of sterile products currently being manufactured, wholesaled and distributed;

(b) The name and contact information for any laboratory, corporation, or other organization that may perform sterility and potency testing, or similar procedures for the purposes of quality assurance on any drug or biologic product produced by the applicant;

(4) Changes in any information in paragraphs (1), (2), or (3) of this rule shall be submitted in writing to the Board of Pharmacy immediately.

(5) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board's authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

Notes

Tenn. Comp. R. & Regs. 1140-09-.02

Original rule filed January 7, 1992; effective February 21, 1992. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Emergency rules filed January 31, 2014 expired effective July 31, 2014. The rules reverted to their previous status. Amendments filed July 11, 2014; effective October 9, 2014. Repeal and new rule filed March 24, 2015; effective June 22, 2015. Amendments filed November 22, 2016; effective 2/20/2017.

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-305, and 63-10-306.