§ 433.23 - Microbiological culture media containing antibiotics.

Microbiological culture media that contain any certifiable antibiotic drug subject to the regulations in this chapter shall be exempt from the requirements of sections 502(l) and 507 of the act and the certification requirements of section 512(n) of the act if:

(a) They are intended for use in tissue culture and the antibiotic drug is added solely for use as an aid in the prevention of microbial contamination; or

(b) They are intended for use in the isolation of selected organisms from mixed cultures and the antibiotic drug is added solely for use as an aid in such isolation; and

(c) The certifiable antibiotic drug used in such culture media complies with the applicable standards of identity, strength, quality, and purity prescribed therefor.