Walgreens Boots Alliance, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your “Walgreens Allergy Eye Drops,” “Walgreens Stye Eye Drops,” and “Walgreens Pink Eye Drops” are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for “Walgreens Allergy Eye Drops,” “Walgreens Stye Eye Drops,” and “Walgreens Pink Eye Drops.” Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Passage 2

The significant violations of Current Good Manufacturing Practice (CGMP) requirements observed at **(b)(4)**, with respect to its manufacture of homeopathic ophthalmic products, are documented in the Agency’s **(b)(4)** warning letter to **(b)(4)**. Under section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B), drugs are deemed adulterated if they are not manufactured in conformance with CGMP. The CGMP violations identified at **(b)(4)** caused all drug products manufactured by **(b)(4)** to be adulterated. The introduction, delivery for introduction, or causing the introduction or delivery for introduction into interstate commerce of an adulterated drug is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Further, the receipt in interstate commerce of adulterated drugs, and the delivery or proffered delivery thereof, is a violation of section 301(c) of the FD&C Act, 21 U.S.C. 331(c).

Passage 3

Accordingly, we are concerned that your use of silver sulfate as a preservative in your ophthalmic products is inconsistent with 21 C.F.R. 200.50(b)(1), under which ophthalmic preservatives should be “suitable and harmless.”