Re: Why not ?

PIMA syrup is in the PDR, listed as a drug by prescription, basically SSKI is concentrated PIMA, without the sugar. I'd never consider shipping anything listed as a drug, but that's just me :) I don't think its worth the potential trouble, working at Wal-mart for minimum wage is probably a better proposition in the long-run.

"Any drugs or active pharmaceutical ingredients (API) manufactured, prepared, propagated, compounded, or processed at a facility for which required facility fees have not been paid or required self-identifying information has not been submitted, or drugs containing an active pharmaceutical ingredient manufactured, prepared, propagated, compounded, or processed at such a facility are misbranded. 21 U.S.C. §§ 352(aa), 379j-42(g)(4)(A)(iii). It is a violation of federal law to ship misbranded products in interstate commerce, which includes causing such products to be imported into the United States. 21 U.S.C. § 331(a). Such violations can result in injunctions or seizures of the misbranded products. See 21 U.S.C. §§ 332 and 334. Products that appear to be misbranded may also be denied entry into the United States. 21 U.S.C. § 381(a)(3). Facilities that fail to pay the annual facility fee are placed on a publicly available GDUFA facility arrears list. Any generic drug submission from the person responsible for paying the fee, or from an affiliate of that person, will not be received by FDA within the meaning of 21 U.S.C. § 355(j)(5)(A). In addition, any new generic drug submission that references such a facility will not be received, within the meaning of 21 U.S.C. § 355(j)(5)(A), if the outstanding facility fee is not paid within 20 calendar days of FDA providing notification to the sponsor of the failure of the owner of the facility to pay the facility fee. 21 U.S.C. § 379j-42(4)(ii).

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm412597.htm


Tweet