§73.1375. Pyrogallol. — Inbound Citations

(c) Ferric ammonium citrate may be safely used in combination with pyrogallol (as listed in § 73.1375), for coloring plain and chromic catgut sutures for use in general and ophthalmic surgery subject to the following conditions:

(1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980).

(2) The level of the ferric ammonium citrate-pyrogallol complex shall not exceed 3 percent of the total weight of the suture material.

(3) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissue.

(4) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the act, is in effect for it.