California Health and Safety Code

§ 111635

HSC § 111635 Effective Jan 1, 2013Div. 104 · Part 5 · Ch. 6 · Art. 6

Statute text

(a)Prior to issuing a license required by Section 111615 to any place of business where a drug or device is manufactured, the department shall receive from each place of business documentation that evidences ownership and any of the following:

(1)The place of business is operating pursuant to a valid biologics license issued by the United States Food and Drug Administration in compliance with Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).

(2)The place of business is operating with a valid establishment registration pursuant to Section 510 of the federal act (21 U.S.C. Sec. 360). This documentation shall include an attestation from an officer of the place of business that a federal inspection was completed within the two years prior to the date of the attestation.

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Legislative history

Amended by Stats. 2012, Ch. 688, Sec. 2. (AB 1277) Effective January 1, 2013.