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Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations
… uidance-documents/small-volume-parenteral-drug-products-and-pharmacy-bulk-packages-parenteral-nutrition-aluminum … … content of small volume parenteral (SVP) drug products and pharmacy bulk packages (PBPs) used in PN are not specified by … Document … Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum …
Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of all Sterile Products Produced at Advanced Pharma Houston Location from September 1, 2016 through February 16, 2017 Due to Potential Inaccuracy of Latex Free Label Reference
… unable to confirm with clarity whether its “latex free” label statements are accurate in all cases and are therefore … facilities (hospitals and institutions). Avella Specialty Pharmacy is committed to patient safety in all instances and … unable to confirm with clarity whether its “latex free” label statements are accurate in all cases and are therefore …
FDA investigates two adverse events associated with United Pharmacy’s compounded glutamine, arginine, and carnitine product for injection
… 2018 FDA laboratory analysis found the glutamine in United Pharmacy’s compounded glutamine, arginine, and carnitine … beyond-use date (BUD) of 6 months specified on the product label. Previously, FDA reported the product was labeled as … (API) collected from the API supplier used by United Pharmacy and determined the average purity of the samples to …
Frequently Asked Questions about Labeling for Prescription Medicines
… assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and certified public health … of credit. For those of you who are pharmacists or pharmacy technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy—otherwise known as “NABP”—provided you add your NABP …
Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
… health care professional. This practice is called “pharmacy-level substitution” and is subject to state law. … interchangeability is relevant to substitution at the pharmacy. We believe that statements in the Prescribing … reference products. Our updated guidance will not impact pharmacy-level substitution of interchangeable biosimilar …
FDA Drug Topics: The Ins and Outs of Prescription Drug Labeling
… assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and certified public health … of credit. For those of you who are pharmacists or pharmacy technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy—otherwise known as “NABP”—provided you add your NABP …
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy - 606489 - 03/31/2020
… -solutions-pharmacy-center-inc-dba-professional-compounding-pharmacy-606489-03312020 … WARNING LETTER March 31, 2020 Dear … investigators inspected your facility, Health Solutions Pharmacy Center, Inc. dba Professional Compounding Pharmacy, … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …
Reliable Rexall-A Compounding Pharmacy - 511750 - 03/09/2017
… -investigations/warning-letters/reliable-rexall-compounding-pharmacy-511750-03092017 … San Francisco District … of your facility, Reliable Rexall –A Compounding Pharmacy, located at 801 Irving St. San Francisco, CA … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …
Joe Wise Pharmacy, Inc., dba Wise Pharmacy - 613927 - 04/15/2021
… cement-and-criminal-investigations/warning-letters/joe-wise-pharmacy-inc-dba-wise-pharmacy-613927-04152021 … WARNING LETTER April 15, 2021 Dear … (FDA) investigator inspected your facility, Joe Wise Pharmacy, Inc. dba Wise Pharmacy, located at 6179 S. Balsam …
Strohecker's Pharmacy - 523164 - 09/18/2017
… ent-and-criminal-investigations/warning-letters/stroheckers-pharmacy-523164-09182017 … Division of Pharmaceutical … September 18, 2017 Ronald P. Dulwick, Owner Stroheckers Pharmacy, Inc. dba Stroheckers Pharmacy 1286 SE Holgate … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …
Pharmakon Compounding Pharmacy, Inc. - 523191 - 09/07/2017
… iminal-investigations/warning-letters/pharmakon-compounding-pharmacy-inc-523191-09072017 … Division of … Paul J. Elmer, R.Ph., Owner Pharmakon Compounding Pharmacy. Inc. 14460 Getz Road, Suite 300 Noblesville, … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …
San Diego Compounding Pharmacy - 520259 - 09/25/2017
… iminal-investigations/warning-letters/san-diego-compounding-pharmacy-520259-09252017 … Division of Pharmaceutical … Owner and Chief Executive Officer San Diego Compounding Pharmacy, P.C. 5395 Ruffin Rd., Suite 104 San Diego, CA 92123 … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …
United Pharmacy - 553916 - 02/11/2019
… orcement-and-criminal-investigations/warning-letters/united-pharmacy-553916-02112019 … February 11, 2019 Case #553916 … LETTER VIA UPS EXPRESS Mikhail Vesselov, Owner United Pharmacy, LLC 3951 Haverhill Rd N West Palm Beach, Florida … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …
Vita Pharmacy, LLC dba Talon Pharmacy of Boerne - 639220 - 08/29/2022
… nforcement-and-criminal-investigations/warning-letters/vita-pharmacy-llc-dba-talon-pharmacy-boerne-639220-08292022 … Date: August 29, 2022 Case … (FDA) investigator inspected your facility, Vita Pharmacy, LLC dba Talon Pharmacy of Boerne, located at 1430 …
Arnold Professional Pharmacy - 521908 - 04/07/2017
… criminal-investigations/warning-letters/arnold-professional-pharmacy-521908-04072017 … Baltimore District … Neil P. McGarvey, Pharm.D., Co-Owner Arnold Professional Pharmacy 1460 Ritchie Highway, Suite 103 Arnold, MD 21012 … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …
Elkhart Pharmacy - 508507 - 05/08/2017
… rcement-and-criminal-investigations/warning-letters/elkhart-pharmacy-508507-05082017 … Dallas District Office … Charles H. Stanton, R.Ph. Pharmacist in Charge Elkhart Pharmacy 306 US Hwy 287 Elkhart, Texas 75839 Dear Mr. … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …
Loop Pharmacy & Home Medical - 537129 - 09/20/2017
… nforcement-and-criminal-investigations/warning-letters/loop-pharmacy-home-medical-537129-09202017 … Division of … 20, 2017 William S. McFarland, Owner Loop Plaza Pharmacy, Co. dba Loop Pharmacy & Home Medical 72 6th Avenue … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …
Dougherty's Pharmacy - 500635 - 05/12/2017
… ment-and-criminal-investigations/warning-letters/doughertys-pharmacy-500635-05122017 … U.S. Food & Drug … conducted an inspection of your facility, Dougherty’s Pharmacy Preston Royal, located at 5959 Royal Ln., Suite 515, … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and …
Tri-Coast Pharmacy - 525312 - 08/20/2018
… ement-and-criminal-investigations/warning-letters/tri-coast-pharmacy-525312-08202018 … August 20, 2018 … VIA UPS OVERNIGHT Kevin P. O’Connell, Owner Tri-Coast Pharmacy, Inc. 14125 US Highway 1 Juno Beach, FL 33408-1425 … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …
Accurate RX Pharmacy Consulting LLC dba Accurate Rx Pharmacy - 604449 - 09/02/2020
… letters/accurate-rx-pharmacy-consulting-llc-dba-accurate-rx-pharmacy-604449-09022020 … September 2, 2020 WARNING LETTER … (FDA) investigator inspected your facility, Accurate Rx Pharmacy Consulting LLC dba Accurate Rx Pharmacy, located at 103 Corporate Lake Drive, Suite B, …
Hieber's Pharmacy - 542220 - 12/05/2017
… rcement-and-criminal-investigations/warning-letters/hiebers-pharmacy-542220-12052017 … Division of Pharmaceutical … 5, 2017 Mr. Joseph G. Bettinger Owner Hieber’s Pharmacy, Inc. 3500 5 th Avenue Pittsburgh, PA 15213-3337 … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …
Montana Compounding Pharmacy PC - 521947 - 05/09/2018
… criminal-investigations/warning-letters/montana-compounding-pharmacy-pc-521947-05092018 … WARNING LETTER … Roy “Tim” G. Calcagno, R.Ph., Owner Montana Compounding Pharmacy, P.C. dba Mont ana Compounding Pharmacy and Wellness … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …
Ladd Family Pharmacy LLC - 516046 - 09/26/2017
… ent-and-criminal-investigations/warning-letters/ladd-family-pharmacy-llc-516046-09262017 … Division of … 26, 2017 Jeremy B. Lundevall, Owner Ladd Family Pharmacy, LLC 1109 S Broadway Avenue Boise, Idaho 83706-3626 … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …
Labeling Requirements - Exemptions From Adequate Directions For Use
… possession of, persons lawfully engaged in instruction in pharmacy, chemistry, or medicine (not involving clinical …
Guardian Pharmacy Services - 534027 - 11/03/2017
… cement-and-criminal-investigations/warning-letters/guardian-pharmacy-services-534027-11032017 … Office of … Jack R. Munn, Owner JMA Partners, Inc., dba Guardian Pharmacy Services 7920 Elmbrook Drive, Suite 108 Dallas, … to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the …