Bausch & Lomb Incorporated – FDA Warning Letter, Oct 2, 2012

This FDA Warning Letter, FLA-13-01, dated October 2, 2012, was issued to Bausch & Lomb, Inc. regarding their manufacture of unapproved new drugs, specifically Pilocarpine Hydrochloride Ophthalmic Solutions (0.5%, 1%, 2%, 3%, 4%, 6%).

The FDA determined these products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses. Consequently, their introduction into interstate commerce without FDA-approved applications violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)].

Additionally, as prescription drugs, their labeling lacks adequate directions for lay use, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Since they lack approved applications, they are not exempt from this requirement, violating section 301(a) of the Act [21 U.S.C. § 331(a)].

The FDA stated it does not intend to initiate enforcement action if manufacturing ceases within 9