Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm340262.htm
Timestamp: 2019-04-19 04:21:33+00:00

Document:
The United States Food and Drug Administration (FDA) reviewed your website, www.buy-pharma.com, on January 8, and has determined that www.buy-pharma.com offers products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the website offers a misbranded and unapproved new drug for sale in violation of sections 502(f) and 505(a) of the FD&C Act [21 U.S.C. §§ 352(f) and 355(a)], which are prohibited acts under sections 301(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 331(a) and 331(d)], respectively. We request that you immediately cease marketing violative drug products to United States consumers.
Pirfenidone is offered for sale on www.buy-pharma.com under the brand name Pirfenex. Pirfenidone is a drug within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or it is intended to affect the structure or function of the body. Moreover, pirfenidone appears to be 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 for its labeled use. Pirfenidone Information Sheet 2 found at http://www.buy-pharma.com/img/uploads/5585-pirfenex-pirfenidone-information-sheet-2.jpg, states “Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis.” This claim establishes pirfenidone as a drug.
Although pirfenidone is approved in Canada under the brand name Esbriet, there is no approved application pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for this drug product. Accordingly, its introduction or delivery for introduction into interstate commerce violates section 505(a) of the FD&C Act [21 U.S.C. § 355(a)], which is prohibited under section 301(d) of the FD&C Act [21 U.S.C. § 331(d)].
Because pirfenidone is 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 it so that a layman can use this product safely for its intended use. Consequently, its labeling fails to bear adequate directions for its intended use, causing it to be misbranded within the meaning of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Because pirfenidone lacks a required approved application, it is not exempt from the requirements of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] as described in Title 21 of the Code of Federal Regulations (21 CFR) § 201.115. The introduction or delivery for introduction into interstate commerce of a misbranded drug product is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. §331(a)].
FDA is taking action against your firm because of the inherent risk in buying misbranded and unapproved new drugs. Unapproved new drugs may not have the same assurance of safety, efficacy, and quality as drugs subject to FDA oversight, and such drugs have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. FDA-regulated drugs offer protections that include rigorous scientific standards for new drug approval, labeling review for accuracy and completeness, and manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. must be licensed by the states. Unapproved new drugs delivered to the American public may not be safe and effective.
This letter is not intended to identify all of the ways in which your activities might be in violation of law. It is your responsibility to ensure that all drug products marketed by your firm are in compliance with FD&C Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in FDA regulatory action, including but not limited to, seizure or injunction, without further notice.
Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to DrugSupplyChainIntegrity@fda.hhs.gov. Please direct any inquiries concerning this letter to Eleni Anagnostiadis, Acting Deputy Director for the Division of Supply Chain Integrity at the above address.

References: § 321
 § 321
 § 355
 § 355
 § 331
 § 352
 § 352
 § 201
 §331