Drugs | Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831*** | Lot number: 12052013:03 Expiration date: 06/03/2014 | Class II | Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping | RX South LLC DBA RX3 Pharmacy |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, March 26, 2014
RX south LLC dba RX# Pharmacy--
Hospira, Inc. Particles in vial
Drugs | Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30. | Lot 25-220-DD, Exp 1JAN2015 | Class I | Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored. | Hospira Inc. |
Oklahoma Told It Can’t Shield Suppliers of Execution Drugs
An Oklahoma judge ruled on Wednesday that the state could not keep secret the identities of the suppliers of lethal-injection drugs, raising doubts about the executions of two prisoners next month and fueling a growing legal battle in several states over secrecy in methods of execution.
The state argued that a supplier-secrecy law, passed in 2011, was necessary because of a shortage of execution drugs and threats against companies that supply them. But lawyers for the two prisoners, Clayton Lockett and Charles Warner, countered that without knowing the source of the drugs, courts could not determine whether the execution protocol satisfied the constitutional ban on cruel and unusual punishment, and prisoners were denied the right to know, and potentially question, how they would be put to death.
Judge Patricia Parrish, of the Oklahoma County District Court, declared the secrecy statute to be an unconstitutional violation of due process in an oral decision from the bench.
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Condemned inmates seek info on lethal drug By Mike Ward, Austin Bureau : March 26, 2014
AUSTIN — Two condemned killers, including a one-time drifter who claimed he killed 70 people in a cross-country crime spree spanning 19 years, have sued state officials to force them to disclose details about the execution drugs that will be used to end their lives.
In a lawsuit filed in Travis County state court, Tommy Lynn Sells, 49, and Ramiro Hernandez Llanes, 44, alleged the Texas Department of Criminal Justice is illegally refusing to provide their attorneys with information about the powerful barbiturate pentobarbital that will be used to execute them, despite earlier court orders and attorney general opinions making that information available to them and the public.
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In a lawsuit filed in Travis County state court, Tommy Lynn Sells, 49, and Ramiro Hernandez Llanes, 44, alleged the Texas Department of Criminal Justice is illegally refusing to provide their attorneys with information about the powerful barbiturate pentobarbital that will be used to execute them, despite earlier court orders and attorney general opinions making that information available to them and the public.
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IACP Announces It is Tracking 61 pieces of legislation on behalf of IACP Members
IACP RX Hot off the Presses! Click here
http://bit.ly/1gYm4zS for today's issue of IACP's Compounders Stateside - Your State Compounding Legislation Tracker. IACP is now monitoring more than 61 pieces of legislation on behalf of IACP Members!
Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations--31 Comments Now Available for Public Viewing
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See Attached
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Public Submission
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Posted:03/10/2014
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ID:FDA-2013-N-1523-0008
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Agency:FDA
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RIN:Not Assigned
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Docket ID:
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Organization:
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Submitter Name:
Comment Period Closed
Mar 04, 2014 11:59 PM ET
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NOMINATION: Human Chorionic Gonadotropin (hCG) in any dosage form not injectable (i.e. it is "difficult to compound" hCG in oral, sublingual, intranasal, and topical delivery...
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Public Submission
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Posted:02/06/2014
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ID:FDA-2013-N-1523-0002
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Agency:FDA
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RIN:Not Assigned
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Docket ID:
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Organization:
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Submitter Name:
Comment Period Closed
Mar 04, 2014 11:59 PM ET
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See Attached
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Public Submission
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Posted:03/07/2014
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ID:FDA-2013-N-1523-0007
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Agency:FDA
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RIN:Not Assigned
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Docket ID:
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Organization:
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Submitter Name:
Comment Period Closed
Mar 04, 2014 11:59 PM ET
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See attached file(s)
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Public Submission
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Posted:03/21/2014
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ID:FDA-2013-N-1523-0030
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Agency:FDA
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RIN:Not Assigned
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Docket ID:
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Organization:
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Submitter Name:
Comment Period Closed
Mar 04, 2014 11:59 PM ET
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See attached file(s)
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Public Submission
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Posted:03/21/2014
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ID:FDA-2013-N-1523-0029
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Agency:FDA
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RIN:Not Assigned
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Docket ID:
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Organization:
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Submitter Name:
Comment Period Closed
Mar 04, 2014 11:59 PM ET
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See attached file(s)
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Public Submission
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Posted:03/21/2014
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ID:FDA-2013-N-1523-0021
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Agency:FDA
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RIN:Not Assigned
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Docket ID:
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Organization:
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Submitter Name:
Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Request for Nominations--Letters Posted so Far for Public Viewing
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See Attached
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Public Submission
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Posted:03/07/2014
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ID:FDA-2013-N-1525-0002
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Agency:FDA
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RIN:Not Assigned
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Docket ID:
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Organization:
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Submitter Name:
Comment Period Closed
Mar 04, 2014 11:59 PM ET
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