[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR205.5]
[Page 113-114]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 205 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG
Sec. 205.5 Minimum required information for licensure.
(a) The State licensing authority shall require the following
minimum information from each wholesale drug distributor as part of the
license described in Sec. 205.4 and as part of any renewal of such
license:
(1) The name, full business address, and telephone number of the
licensee;
(2) All trade or business names used by the licensee;
(3) Addresses, telephone numbers, and the names of contact persons
for all facilities used by the licensee for the storage, handling, and
distribution of prescription drugs;
(4) The type of ownership or operation (i.e., partnership,
corporation, or sole proprietorship); and
(5) The name(s) of the owner and/or operator of the licensee,
including:
(i) If a person, the name of the person;
(ii) If a partnership, the name of each partner, and the name of the
partnership;
(iii) If a corporation, the name and title of each corporate officer
and director, the corporate names, and the name of the State of
incorporation; and
(iv) If a sole proprietorship, the full name of the sole proprietor
and the name of the business entity.
[[Page 114]]
(b) The State licensing authority may provide for a single license
for a business entity operating more than one facility within that
State, or for a parent entity with divisions, subsidiaries, and/or
affiliate companies within that State when operations are conducted at
more than one location and there exists joint ownership and control
among all the entities.
(c) Changes in any information in paragraph (a) of this section
shall be submitted to the State licensing authority as required by such
authority.
(Approved by the Office of Management and Budget under control number
0910-0251)
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