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503B Is the Future of Compounding 503B is the Future of Compounding... Get Informed! Stokes503B.com Stokes' tablet press machine Stokes' aseptic area where sterile injection vials are being processed under ISO 5 conditions in our clean room Stokes aseptically processes sterile ophthalmics under 100% visual inspection by a Stokes quality control technician ISO 5 conditions in our cleanroom © Stokes Healthcare 2019 888-508-503B FDA Registered 503B TM 503B Outsourcing Facility Veterinarians Deserve a NEW, Better Way! FDA Registered 503B 503A Traditional NEW Outsourcing Facility OLD Compounding Pharmacy Manufactured Product Compounded Preparation Products always tested per cGMP Limited/No Testing FDA Approved Facility Not an FDA Approved Facility Follow cGMP under FDA oversight TM 503B Follow USP under state board of pharmacy Unlimited administration in all 50 states Unlimited administration NOT permitted in all states Authorized to compound large batches NOT allowed to compound large batches Must mantain quality department No quality department required 10 Reasons to Order from Stokes 503B 1 1) Available for dispensing and unlimited hospital administration in all 50 states 2) All medications have a readily accessible Certificate of Analysis 3) Consistent quality and integrity of products from batch to batch 4) All products made under cGmp2; same FDA regulations followed by the pharmaceutical manufacturing industry 5) Medications are measured throughout the whole process and verified through stability and sterility 6) Decreased Liability 7) 48 hour turnaround time 8) Stokes is trusted and has been in business since 1975 9) Stokes is a licensed outsourcer in most states 10) Stokes is one of the only compounding pharmacies in the veterinary industry to achieve 503B registration and has more 503B veterinary medications available than any other outsourcer 1 Varies based on individual state law. Federal law allows dispensing and administration - FDA Federal SEC. 503B. [21 U.S.C. 353b] | 2 cGMP - Current Good Manufacturing Practices Is Stokes 503B Currently Licensed in Your State? For the latest updates, go to Stokes503B.com The FDA Commissioner has stated that all hospitals should order compounded medication from an FDA Registered 503B Outsourcing Facility. Choosing Stokes 503B preparations is a critical step you can take to better ensure the health and safety of your patients. Get Informed! Stokes503B.com TM 503B ORDER TODAY! 888-508-503B or FDA 503B Registered Outsourcing Facility myifill.com Stokes 503B & Stokes Pharmacy are subsidiaries of Stokes Healthcare, Inc. Stokes B Injections • Buprenorphine 0.5 mg/mL Injection Solution, 10 mL and 50 mL • Diazepam 5 mg/mL Injection Solution, 30 mL • Fomepizole 1.5 gm Injection Solution, 30 mL • Hydromorphone 2 mg/mL Injection Solution, 10 mL • Methadone HCL 10 mg/mL Injection Solution, 10 mL • Prednisolone Acetate 25 mg/mL Injection Suspension, 30 mL • Metoclopramide 5 mg/mL injection Solution, 50 mL • Stanozolol 50 mg/mL Injection Suspension, 30 mL Stokes B Ophthalmics • Chloramphenicol 1% Ophthalmic Solution, 10 mL • Cidofovir 0.5% Ophthalmic Solution, 5 mL • Cyclosporin AQ 1% and 2% Ophthalmic Suspension,10 mL • Cyclosporin Coconut Oil 1% and 2% Ophthalmic Solution, • Megestrol Acetate 0.5% Ophthalmic Suspension, 10 mL 15 mL • Pilocarpine HCL 0.1% Ophthalmic Solution, 10 mL • Cyclosporin Corn Oil 1% and 2% Ophthalmic Solution, 10 mL • Prednisolone Acetate 1.5% Ophthalmic Suspension, 10 mL • Cyclosporin Olive Oil 2% Ophthalmic Solution, 10 mL • Tacrolimus AQ 0.02%, 0.03%, 0.1%, 0.5% and 1% Ophthalmic • Cyclosporin/Tacrolimus MCT Oil 2/0.02% and 2/0.03% Suspension, 10 mL Ophthalmic Solution, 10 mL • Tacrolimus AQ 0.02% and 0.03% Ophthalmic Suspension, • Demecarium Bromide 0.125% and 0.25% Ophthalmic 15 mL Solution, 10 mL • Tacrolimus Corn Oil 0.02 and 0.03% Ophthalmic Solution, • Dipivefrin Hydrochloride 0.1% Ophthalmic Solution,10 mL 10 mL • EDTA 1% and 2% Ophthalmic Solution, 15 mL • Tacrolimus Corn Oil 0.02% and 0.03% Ophthalmic Solution, • EDTA 2% Ophthalmic Gel, 5 gm 15 mL • Flurbiprofen Sodium 0.04% Ophthalmic Solution, 10 mL • Tacrolimus MCT 0.2%, 0.3%, 0.5% and 1% Ophthalmic Solution, 10 mL • Idoxuridine 0.1% Ophthalmic Solution, 15 mL • Tacrolimus MCT 0.02% and 0.03% Ophthalmic Solution,15 mL Stokes B Tablets For a list of tablet strengths, go to bit.ly/stokestabs • Amlodipine • Diethylstilbestrol • Fluoxetine • Methimazole • Pimobendan • Theophylline • Aspirin (DES) • Gabapentin • Metronidazole • Piroxicam • Tramadol • Atenolol • Doxycycline • Ketoconazole • Mirtazapine • Prazosin • Trilostane • Budesonide • Famciclovir • Leflunomide • Mycophenolate • Prednisolone • Ursodiol • Cisapride • Fludro- • Meloxicam • Phenoxy- • Sildenafil cortisone • Clopidogrel • Methazolamide benzamine • Tadalafil SA06102019 SA06182019.
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  • ENFORCEMENT and COMPOUNDING COMMITTEE REPORT July 12, 2017
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