Bausch & Lomb, Inc. 10/2/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Florida District|
555 Winderley Place, Suite 200
Maitland, Florida 32751
October 2, 2012
Executive Vice President
Bausch & Lomb, Inc.
8500 Hidden River Pkwy.
Tampa, FL 33657
Products: Pilocarpine Hydrochloride Ophthalmic Solutions
Dear Mr. Wechsler:
This letter is written in reference to your firm’s manufacturing unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Based on the information your firm submitted to FDA's Drug Registration and Listing System, you manufacture the following prescription drugs:
Pilocarpine Hydrochloride Ophthalmic Solution 0.5%
Pilocarpine Hydrochloride Ophthalmic Solution 1%
Pilocarpine Hydrochloride Ophthalmic Solution 2%
Pilocarpine Hydrochloride Ophthalmic Solution 3%
Pilocarpine Hydrochloride Ophthalmic Solution 4%
Pilocarpine Hydrochloride Ophthalmic Solution 6%
As labeled, these products are drugs within the meaning of section 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and (C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and intended to affect the structure or any function of the body of man or other animals. Further, these drug products, as manufactured by your firm, are "new drugs" within the meaning of 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. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)]. There are no FDA-approved applications on file for these products. Manufacturing these products or other new drugs without approved applications therefore violates these provisions of the Act.
Additionally, because the above products are prescription drugs within the meaning of section 503(b)(1) of the Act [21 U.S.C. § 353(b)(1)], adequate directions cannot be written so that a layman can use these products safely for their intended uses. See 21 C.F.R. 201.5. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(l) of the Act [21 U.S.C. § 352(f)(1)]. Because your products lack required approved applications, they are not exempt under 21 C.F.R. 201.115 from the requirements of section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Consistent with its "Marketed Unapproved Drugs - Compliance Policy Guide,"
FDA does not intend to initiate enforcement action related to your unapproved Pilocarpine Hydrochloride Ophthalmic Solution, unless the manufacturing of these products continues for more than 90 days after the date of this letter. Furthermore, FDA does not intend to initiate enforcement action related to the shipment in interstate commerce of these products unless they are still being shipped more than 180 days after the date of this letter.
You should be aware that FDA’s enforcement discretion will not apply if (1) FDA determines that your firm is violating other provisions of the Act; (2) it appears that your firm, in response to this letter, increases its manufacture or distribution of your unapproved Pilocarpine Hydrochloride Ophthalmic Solution above your usual volume during these periods; or (3) FDA learns of new information regarding any serious health risk or hazard associated with these drug products.
The violations cited in this letter are not necessarily limited to pilocarpine that you manufacture. Rather, they may apply to all drug products that you manufacture without FDA-approved applications. You are responsible for (1) investigating and determining the causes of the violations identified above; (2) preventing their recurrence or the occurrence of other violations; and (3) assuring that your firm complies with all requirements of Federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Within fifteen (15) working days of receipt of this letter, please notify this office in writing whether you plan to cease the violative activities described in this letter. Indicate:
· whether you no longer manufacture the products referenced in this letter;
· the reasons for, and the date on which, you ceased manufacture;
· the name and address of any other manufacturer, supplier, or distributor of these products; and
Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other Federal agencies may take this Warning Letter into account when awarding contracts.
Your written response should be sent to Food and Drug Administration, Attention: Andrea Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Ms. Norwood at (407) 475-4724.
Emma R. Singleton
Director, Florida District