Inspections, Compliance, Enforcement, and Criminal Investigations
Breckenridge Pharmaceutical, Inc.
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|555 Winderley Pl., Ste. 200
Maitland. FI 32751
RETURN RECEIPT REQUESTED
February 9, 2010
Laurence D. Runsdorf, President
Breckenridge Pharmaceuticals, Inc.
1141 S Roger Cir Ste 3
Boca Raton, FL 33487
Dear Mr. Runsdorf:
On (b)(4), FDA issued a (b)(4) (copy attached). As explained more fully in that (b)(4) certain drug products that Provident has manufactured are new drugs that lack approved applications as required under the Federal Food, Dru and Cosmetic Act the Act. (b)(4) These drug products include, but are not necessarily limited to:
• Trital SR Tablets (Chlorpheniramine Maleate 8mg; Phenylephrine HCI 40mg; Acetaminophen 325mg; Phenyltoloxamine Citrate 50mg)
• Migrazone Capsules (Isometheptene Mucate 65mg; Dichloraphenazone USP 100mg; Acetaminophen 325mg)
The above products are drugs within the meaning of section 201 (g) of the Act, [21 U.S.C. § 321(g)] because, as demonstrated by their labeling, they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Further, they 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 use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301 (d) and 505(a) of the Act [21 U.S.C. §§ 331(a), (d) and 355(a)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for the drug. Based on our information, there are no FDA-approved applications on file for these drug products.
Additionally, because the above prescription drug products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses, as described in 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)(1) of the Act [21 U.S.C. 352(f)(1)]. Because the 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 without approved new drug applications violates section 301(a) and (d) of the Act [21 U.S.C. 331(a) and (d)].
Further, as explained in the (b)(4) above drug products are adulterated, 21 U.S.C. 351(a)(2)(B), and thus your firm may not introduce or deliver them for introduction into interstate commerce, 21 U.S.C. § 331 (a).
The violations cited in letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. In particular, violations cited in this letter are not necessarily limited to drug products manufactured by Provident and may apply to all drug products that you market without FDA-approved applications. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure 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. 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 (b)(4) into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer market the above products, your response should so indicate, including the reasons that, and the date on which, you ceased production.
Your reply should be sent to the U.S. Food and Drug Administration, Attention: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Mr. Alejo at (407) 475-4731.
Emma R. Singleton
Director, Florida District