- Better Rx, LLC
- Issuing Office:
- Dallas District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District Office|
4040 North Central Expressway
Dallas, Texas 75204-3128
February 2, 2016
Mr. Viet Nguyen
Chief Executive Officer and Owner
Better Rx, LLC
122 East Roselane Drive, Suite C
Houston, Texas 77076
Dear Mr. Nguyen:
From July 20, 2015 through July 23, 2015, an Investigator from the U.S. Food and Drug Administration (FDA) conducted an inspection of your pharmaceutical own-label distribution facility, Better Rx, LLC (“Better Rx” or “your firm”), located at 122 East Roselane Drive, Suite C, Houston, Texas 77076, and your permanent office located at Little York Pharmacy, doing business as KVO, LLC, at 7404 Airline Drive, Houston, Texas 77076.
This inspection revealed that your firm ordered and received through interstate commerce unapproved new drugs that violate the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Causing the introduction of unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)]. Furthermore, since the product is also a misbranded drug under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)], causing its introduction into interstate commerce violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
Unapproved New Drug Violations
Based on information collected during the inspection, we have determined that you caused the introduction of unapproved new drugs into interstate commerce in violation of sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)].
The unapproved new drug at issue is: Soothee Patch (lidocaine 0.5%, menthol 5%, and methyl salicylate 2%), NDC 69592-001, labeled for topical “temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness.”
As labeled, this product is a drug within the meaning of section 201(g)(1) of the FD&C Act [21 U.S.C. §§ 321(g)(1)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and because it is intended to affect the structure or any function of the body of man or other animals. Further, this drug is a “new drug” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in the labeling.
Under sections 301(d) and 505(a) of the FD&C Act, a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the FD&C Act [21 U.S.C. §§ 355(b) or (j)] is in effect for the drug. There are no FDA-approved applications on file for this drug. Causing the introduction of this drug into interstate commerce without an approved application is a violation of these provisions of the FD&C Act.
Misbranded Drugs Under the FD&C Act
The Soothee Patch, NDC 69592-001, is a “prescription drug” under section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)] because, in light of its toxicity or potential for harmful effects, the method of its use, or the collateral measures necessary for its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer it.
Because this drug is not safe for use except under the supervision of a practitioner licensed by law to administer it, adequate directions cannot be written so that a layman can use it safely for its intended uses. Consequently, the labeling of your firm’s unapproved prescription drug product fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Because your drug lacks the required approved application, it is not exempt under 21 CFR 201.115 from the requirements of section 502(f)(1) of the FD&C Act. The above product also is misbranded under section 503(b)(4)(A) of the FD&C Act [21 U.S.C. § 353(b)(4)(A)], in that its label fails to bear the symbol “Rx Only.”
It is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)] to cause the introduction into interstate commerce any drug that is misbranded.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your product. 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 ensure 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 by discontinuing distribution of all of your unapproved drugs at your facility immediately. 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 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 the 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 (15) working days, state the reason for the delay and the time within which you will complete the correction.
All firms are required to electronically update the listing of their products under section 510(j) of the FD&C Act to reflect discontinuation of unapproved products (21 CFR 207.21(b)). Questions about electronic drug listing updates should be sent to eDRLS@fda.hhs.gov. In addition to the required update, firms can also notify the FDA of product discontinuation by sending a letter, signed by the firm’s chief executive officer and fully identifying the discontinued products, including the product NDC numbers, and stating that the manufacturing and/or distribution of the products have been discontinued. FDA plans to rely on its existing records, including its drug listing records, the results of any future inspections, or other available information when considering enforcement action.
Your firm’s response to this letter should be sent to: Dallas District Office, ATTN: John W. Diehl, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the contents of this letter, please contact: John W. Diehl, Compliance Officer, at 214-253-5288.
Reynaldo R. Rodriguez, Jr.
Dallas District Director