Instead of taking other people's word for what you think these cases say, please read!! Here are all three of the federal cases from Texas relating to compounding from bulk animal drugs--Read in order and remember a Federal Circuit Court case takes precedent over anything a federal district court says on the subject

Opinion from the Western District of Texas can be read here   It was overturned by the 5th Circuit Court of Appeals in the case below.  This means it is not good law. It cannot be cited as good law.

Opinion from the First Time the case went to the Fifth Circuit can be read here  In this opinion, the Fifth Circuit said:

The district court concluded, and the Pharmacies argue, that drug products compounded in bulk by pharmacists and veterinarians are not "new animal drugs" and therefore are not "adulterated," "unsafe," or "misbranded" (when lacking "adequate directions for use"). We conclude, to the contrary, that compounded drugs are "new animal drugs" under the FDCA.

Opinion from the Second Time the case went to the Fifth Circuit can be read here  In this opinion, the Fifth Circuit summarized for us what it had ruled in the first Fifth Circuit opinion:

On appeal, we reversed the district court's ruling on the new-drug issue, holding instead that compounded drugs are “new” drugs under the FDCA, but that they are exempt from the FDCA's substantive provisions if they comply with the conditions in §§ 353a and 360b(a).  Med. Ctr. Pharmacy, 536 F.3d at 394.   Therefore, we “VACATED and REMANDED for further proceedings as appropriate in accordance with this opinion.”  Id. at 409.   Our opinion did not address the inspection issue, except to note that “[n]either party appeals the holding[ ] regarding ‘records inspection.’ ”  Id. at 393. - See more at: http://caselaw.findlaw.com/us-5th-circuit/1557109.html#sthash.Qaq2Pbc5.dpuf

On appeal, we reversed the district court's ruling on the new-drug issue, holding instead that compounded drugs are “new” drugs under the FDCA, but that they are exempt from the FDCA's substantive provisions if they comply with the conditions in §§ 353a and 360b(a).  Med. Ctr. Pharmacy, 536 F.3d at 394.   Therefore, we “VACATED and REMANDED for further proceedings as appropriate in accordance with this opinion.”  Id. at 409.   Our opinion did not address the inspection issue, except to note that “[n]either party appeals the holding[ ] regarding ‘records inspection.’ ”  Id. at 393. - See more at: http://caselaw.findlaw.com/us-5th-circuit/1557109.html#sthash.hs7bgPcb.dpuf

On appeal, we reversed the district court's ruling on the new-drug issue, holding instead that compounded drugs are “new” drugs under the FDCA, but that they are exempt from the FDCA's substantive provisions if they comply with the conditions in §§ 353a and 360b(a).  Med. Ctr. Pharmacy, 536 F.3d at 394.   Therefore, we “VACATED and REMANDED for further proceedings as appropriate in accordance with this opinion.”  Id. at 409.   Our opinion did not address the inspection issue, except to note that “[n]either party appeals the holding[ ] regarding ‘records inspection.’ ”  Id. at 393. - See more at: http://caselaw.findlaw.com/us-5th-circuit/1557109.html#sthash.Qaq2Pbc5.dpuf

On appeal, we reversed the district court's ruling on the new-drug issue, holding instead that compounded drugs are “new” drugs under the FDCA, but that they are exempt from the FDCA's substantive provisions if they comply with the conditions in §§ 353a and 360b(a).  Med. Ctr. Pharmacy, 536 F.3d at 394.   Therefore, we “VACATED and REMANDED for further proceedings as appropriate in accordance with this opinion.”  Id. at 409.   Our opinion did not address the inspection issue, except to note that “[n]either party appeals the holding[ ] regarding ‘records inspection.’ ”  Id. at 393. - See more at: http://caselaw.findlaw.com/us-5th-circuit/1557109.html#sthash.Qaq2Pbc5.dpuf

On appeal, we reversed the district court’s ruling on the new-drug issue,

holding instead that compounded drugs are “new” drugs under the FDCA, but


that they are exempt from the FDCA’s substantive provisions if they comply


with the conditions in §§ 353a and 360b(a). Med. Ctr. Pharmacy, 536 F.3d at


394. Therefore, we “VACATED and REMANDED for further proceedings as

 appropriate in accordance with this opinion.” Id. at 409.