FDA LAW Blog: October 28, 2014 FTC and Bayer Head for a Show-Down By Jennifer M. Thomas –

By Jennifer M. Thomas –

Around this time last month, we wrote about the government’s motion for an order to show cause in United States v. Bayer, and the potential lessons to be gleaned from that case.  Bayer entered into a consent decree with the FTC in 2007, which prohibited the company from making any representation about the benefits, performance, or efficacy of a dietary supplement without “competent and reliable scientific evidence” to substantiate such claim.  The current proceedings arise from FTC’s assertion that Bayer lacks such substantiation for its representations about its probiotic product Phillips’ Colon Health.   Now it is time to briefly update our readers, as the saga of Bayer continues.  more

Important Stats: FDA Expectations for 503B Outsourcing Facilities

here

Posted: October 27, 2014 Human Hair Leads to Recall of Lidocaine HCI Injection

here

Minutes from 9/18/14 Hawaii Board of Pharmacy Meeting--discusses DQSA and office use

09.18.14 Pharmacy - Meeting Minutes - Hawaii.gov

hawaii.gov/dcca/pvl/boards/pharmacy/.../140918%20%20min.doc.pdf

6 days ago - compounded drug products as a matter of federal law. The DAG ... 147, a physician assistant authorized to prescribe drugs under Chapter 147A, or an advanced.

FDA Orders New Jersey Company to Destroy Unapproved Drug Products

Federal authorities have ordered a New Jersey company to destroy its unapproved products and stop further manufacturing and distributing them until the drugs receive Food and Drug Administration (FDA) approval. A federal judge from the US District Court for the Southern District of Ohio entered aconsent decree for a permanent injunction against the company, Ascend Laboratories of New Jersey. The unapproved drugs are as follows:

• Pramoxine-HC Otic Drops;
• Hydrocortisone Acetate Suppositories 25 milligrams;
• Urea Cream 39%;
• Urea Cream 40%; and
• Urea Lotion 40%

continue to read here

2014 DNG Trading & Milling, LLC 10/21/14

2014 DNG Trading & Milling, LLC 10/21/14

2014 Vitalab Co Inc 10/16/14

2014 Vitalab Co Inc 10/16/14

2014 Citrus Fit 10/15/14

2014 Citrus Fit 10/15/14

2014 Health & Herbs 10/15/14

2014 Health & Herbs 10/15/14

Look at Who is Purchasing from the Claremore Compounding Pharmacy in Claremore Oklahoma--the Sheriff Jail

PUBLISHED IN THE CLAREMORE DAILY PROGRESS, CLAREMORE, OKLAHOMA, OCTOBER 24, 2014.Purchase Order Claims for October 14, 20142014-2015 148-Drug Court Participant: 36, U. S. Cellular, 21.39, Cell Phone Service;119-Sheriff Civil Fees: 89, Airsoft Tulsa And Outdoor Sports, LLC, 1643.99, Supplies; 90, Uniquely Yours, 75.00, Embroidery; 91, Office Everything, 296.00, Supplies; 92, Atwoods Distributing, 44.99, K-9/Food/Medical/Equipment; 93, Office Everything, 131.02, Supplies; 94, Log Cabin Custom Stitchery, 100.00, Embroidery; 95, Office Everything, 12.79, Paper Products; 96, Atwoods Distributing, 28.61, Parts/Supplies;121-County Clerk Lien Fees: 15, American Floor Mats, 419.12, Floor Mat; 16, Culligan Of Tulsa, 31.90, Services;122-Treasurer Cert. Fees: 12, AT&T Mobility, 158.34, Wireless Connection;127-Sheriff Commissary: 58, Keefe Commissary, 1510.29, Commissary;137-Sheriff Jail: 405, Tiger Inc., 349.30, Utilities; 406, Froman Oil & Propane, 167.65, Fuel; 407, Correctional Dental Services, 1516.04, Dental Services; 408, PHS Mobile X-Ray, 90.00, X-Rays; 409, Westwood Pharmacy, 4703.84, Medication; 410, Performance Food Group, 4998.85, Food; 411, Oklahoma Police Supply, 217.91, Uniforms; 412, Quill Corporation, 1598.63, Supplies; 413, DotCom Leasing LLC, 300.83, Lease Payment(s); 414, Verizon Wireless, 200.05, Services; 415, Bugs Or Us Exterminating, 150.00, Pest Control; 416, W Tech, 4166.67, Services; 417, Claremore Compounding & Pharmacy, 384.36, Medical Supplies; 418, Claremore Compounding & Pharmacy, 31.99, Medical Supplies; 419, Sherwin Williams, 300.90, Paint/Supplies/Markers; 420, Lowes Home Center, 52.17, Supplies; 421, Claremore Compounding & Pharmacy, 129.99, Medical Supplies; 422, Claremore Compounding & Pharmacy, 25.99, Supplies; 423, Burrows Agency, 30.00, Notary Bond; 424, South Central Emergency Serv, 316.00, Medical Services; 425, Sherwin Williams, 336.24, Painting/Supplies; 426, Locke Supply, 10.61, Supplies;142-E-911 Addressing: 44, Froman Oil & Propane, 34.36, Fuel; 45, Oklahoma Communication Systems, 225.90, 911 Access; 46, Voice Products, 1798.12, Maintenance; 47, City Of Claremore, 405.46, Utilities; 48, Cherokee Data Solutions, 866.37, Supplies; 49, Esri Inc, 1200.00, Services;115-Health Department: 113, Rhoten, Angela, 112.00, Travel; 114, InJoy Productions Inc., 431.82, Services; 115, Admiral Express Office Supply, 1291.65, Supplies; 116, Wal-Mart (Health Department), 65.14, Supplies; 117, All Maintenance Supply, 138.00, Supplies;111-Fairboard: 90, The Reporter Publishing Company, 90.00, Advertising; 91, Claremore Daily Progress, 150.00, Advertising; 92, At Your Service Rental, 615.00, Rentals; 93, Tri-Star Roll-Offs, 915.59, Roll Off Waste Container;135-Criminal Justice Authority: 4, Riggs  Abney  Neal, 1085.00, Professional Services;001-General: 1144, Bugs Or Us Exterminating, 400.00, Pest Control; 1145, U. S. Cellular, 166.63, Cell Phone Service; 1146, Cintas Corporation 063, 79.73, Uniform Rental; 1147, Bugs Or Us Exterminating, 25.00, Pest Control; 1148, Bugs Or Us Exterminating, 30.00, Pest Control; 1149, Burrows Agency, 30.00, Notary Bond; 1150, Visual Force Inc, 525.00, Services; 1151, Visual Force Inc, 245.00, Services; 1152, Patterson, Donna, 679.06, Travel; 1153, U. S. Cellular, 166.63, Cell Phone Service; 1154, U. S. Cellular, 48.32, Cell Phone Service; 1155, American Water Products, 32.50, Water Purifier/Treatment; 1156, American Checked Inc, 21.35, Background Check; 1157, House Of Trophies, 5.25, Supplies; 1158, Office Everything, 90.87, Office Supplies; 1159, Targets Online, 1264.37, Services; 1160, Office Everything, 134.68, Supplies; 1161, Office Everything, 57.36, Supplies; 1162, Lowes Home Center, 56.96, Supplies; 1163, Mid-West Extradition Agency, 526.33, Transport; 1164, Janice Cranor, 67.76, Travel; 1165, Walter White, 73.30, Travel; 1166, N.A.C.O., 1505.00, Membership/Dues; 1167, Culligan Of Tulsa, 12.00, Rentals; 1168, Wal-Mart (General Government), 182.99, Supplies; 1169, Copy World Business Solutions, 195.00, Quarterly Maintenance; 1170, Office Everything, 15.16, Office Supplies; 1171, Lowes Home Center, 32.73, Supplies; 1172, Travelers Insurance, 1610.29, Claim; 1173, Speedy Lube, 41.93, Oil Change; 1174, GGEDA/Rogers County, 2500.00, Professional Services; 1175, Hambrick-Furguson Inc, 276.00, Services; 1176, City Of Claremore, 15358.51, Utilities; 1177, American Checked Inc, 8.35, Background Check; 1178, Oklahoma Uniform Building Code Commission, 452.00, Building Permit; 1179, AT&T, 2895.94, Plexar Lines; 1180, INCOG, 7425.50, Membership/Dues; 1181, Turf/Land Equipment, 228.78, Lawnmower Supplies; 1182, Rogers County Dist. #1, 48.13, Fuel; 1183, Oklahoma Association Of Chiefs Of Police, 75.00, Membership/Dues; 1184, RSU Foundation Broadcasting Towers LLC, 450.00, Tower Rental; 1185, Secretary Of State, 5.00, Notary Fee; 1186, Mikes Tires, 386.00, Parts & Labor; 1187, Roy Taylor, 250.00, Deductible Reimbursement;004-1 Cent Sales Tax: 499, Tulsa County BOCC, 1515.00, Signs; 500, Ergon Asphalt & Emulsions, 29173.15, Road Materials; 501, Ergon Asphalt & Emulsions, 14471.05, Road Materials; 502, Hooten Oil Company, 53.67, Oil; 503, Ergon Asphalt & Emulsions, 14524.60, CRS-2 Emulsion/SS-1 Oil; 504, Railroad Yard, 12369.99, Pipe/Steel/Plastic; 505, Tulsa Cleaning Systems, 544.11, Parts/Supplies; 506, Ergon Asphalt & Emulsions, 629.36, CRS-2 Emulsion/SS-1 Oil; 507, Ergon Asphalt & Emulsions, 3914.22, SS1 Tack Emulsion Oil; 508, Ergon Asphalt & Emulsions, 535.17, CRS-2 Emulsion/SS-1 Oil; 509, G.W. Van Keppel Company, 21.60, Keys/Duplicated/Locks/Excessories; 510, R&S Auto Parts Claremore, 255.56, Parts/Supplies; 511, G.W. Van Keppel Company, 501.70, Parts/Supplies; 512, Pryor Stone Company, 595.94, Crusher Run; 513, Ergon Asphalt & Emulsions, 7113.53, Liquid Ashpalt; 514, Ergon Asphalt & Emulsions, 2508.48, Road Materials; 515, Gades Sales Company, Inc, 480.00, Services; 516, Oklahoma Dept Of Transportation, 2151.77, Lease Payment(s); 517, Pryor Stone Company, 631.27, Chips; 518, Pryor Stone Company, 630.51, Crusher Run; 519, Ergon Asphalt & Emulsions, 3228.32, SS1 Tack Emulsion Oil; 520, Guy Engineering Service, 3141.21, Contractual Services; 521, Southwest Trailers & Equipment, 298.40, Parts & Labor;101-T-Highway: 627, U. S. Cellular, 109.72, Cell Phone Service; 628, OReillys Automotive Stores Inc., 316.71, Parts/Supplies; 629, National Waste / Disposal Inc., 295.00, Dumpster; 630, Walkers Hardware And Lumber, 86.28, Supplies; 631, AT&T, 109.00, Phone Service; 632, R.W.D. #4, 141.83, Water Service; 633, Wal-Mart Community/RFCSLLC (District #3), 34.96, Office Supplies; 634, National Waste / Disposal Inc., 1180.00, Roll Off Waste Container; 635, Lowes Home Center, 421.90, Parts/Supplies; 636, Diamond P Lawn & Garden, 85.48, Parts/Supplies; 637, Best Western, 172.64, Lodging; 638, Fullerton Welding Supply, 117.00, Oxygen; 639, R.W.D. #5, 31.00, Water Service; 640, Oklahoma Natural Gas, 81.02, Natural Gas; 641, Oklahoma Natural Gas, 84.14, Natural Gas; 642, Cintas Fas Lockbox 636525, 74.13, Gloves; 643, Equipment One, 96.37, Equipment; 644, Grand Bank, 1672.00, Lease Payment(s); 645, City Of Claremore, 31.80, Services; 646, Cabin Diesel Services, 148.95, Parts/Supplies; 647, Cintas Corporation 063, 344.99, Uniforms; 648, P&K Equipment (Owasso), 174.57, Brush Hog Repair; 649, Harley Smith, 18.47, Reimbursement; 650, OReillys Automotive Stores Inc., 356.55, Tools; 651, U.S. Cellular, 200.62, Services; 652, Copy World Business Solutions, 283.93, Copier Service; 653, Pixley Lumber, 8.96, Repairs; 654, OReillys Automotive Stores Inc., 1875.00, Equipment; 655, Stillwater Milling Company, 28.54, Shop Supplies; 656, R&S Auto Parts Claremore, 49.37, Shop Supplies; 657, Westlake Hardware #73, 55.98, Shop Supplies; 658, Westlake Hardware #73, 56.94, Shop Supplies; 659, Claremore Welding Supply, 156.37, Repairs; 660, Copy World Business Solutions, 214.35, Quarterly Maintenance; 661, Aztec Locksmith, 19.00, Keys/Duplicated/Locks/Excessories; 662, R&S Auto Parts Claremore, 120.63, Parts/Supplies; 663, Pixley Lumber, 61.46, Repairs; 664, Mac Tools, 49.99, Shop Supplies; 665, Cintas Corporation 063, 140.07, Cleaning Service; 666, Office Everything, 188.86, Office Supplies; 667, Imperial Inc, 78.80, Coffee Service; 668, AT&T, 495.08, Utilities; 669, Cintas Corporation 063, 389.17, Uniforms; 670, Claremore Welding Supply, 51.00, Lease Payment(s); 671,  Atwoods Distributing, 29.90, Shop Supplies; 672, Westlake Hardware #73, 17.97, Lubricants/Grease/Oil;113-Property Resale: 36, Mid-West Printing Company, 4343.15, Supplies;
source found here

 

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