The Law of Compounding Medications And Drugs

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

Friday, April 25, 2014


Did Political Pressure Push Oklahoma’s Supreme Court to Lift a Stay of Execution?

Steven Hsieh on April 24, 2014 - 5:12 PM ET
Amid mounting political pressure from lawmakers and state executives, Oklahoma’s Supreme Court ruled Wednesday that two death row inmates are not entitled to know the source of lethal injection drugs that will be used to execute them.
In a ruling, the state’s high court also lifted a stay of execution for Clayton Lockett and Charles Warner that it had issued just two days prior. The two men are scheduled to die by lethal injection on April 29.
State supreme courts typically take weeks or months to rule on constitutional challenges. Yesterday’s decision took a little over forty-eight hours. The timing of the opinion has raised suspicions that the court was motivated by political pressures.
continue to read here
- April 25, 2014 No comments:
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New warnings issued by federal drug regulators suggest that side effects of epidural corticosteroid injections may cause severe injury or even death.

By: Irvin Jackson | Published: April 24th, 2014
New warnings issued by federal drug regulators suggest that side effects of epidural corticosteroid injections may cause severe injury or even death.  
On April 23, the FDA issued a drug safety communication, alerting the medical community and patients about the risk of rare, but serious, neurological problems that can occur after receiving injections of corticosteroids into the epidural space of the spine. The agency says it will require new label warnings for all such injections.
The FDA began reviewing the safety of the injections after medical professionals raised concerns, reporting serious events that have included death, spinal cord infarction, full and partial paralysis, blindness, strokes, seizures, nerve injuries and brain edema.
The agency says that while many patients recovered within minutes to 48 hours after the injections, many patients have never recovered from the epidural steroid injection problems.
Epidural corticosteroid injections are used in the pain management industry to treat neck and back pain, but the FDA has never approved them for that purpose. The agency also warns that they are not proven safe or effective in treating pain.
- See more at: http://www.aboutlawsuits.com/epidural-corticosteroid-injection-warning-63895/#sthash.B2gcPWl3.dpuf
- April 25, 2014 No comments:
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Guidance, Compliance & Enforcement Federal Register Notices

Guidance, Compliance & Enforcement Federal Register Notices
- April 25, 2014 No comments:
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Beloved compounding pharmacy closing

By Wendy Weitzel
April 25, 2014 | Leave Comment
El Macero Pharmacy’s last day is Thursday, customers are being told.
An old-fashioned pharmacy with a new-age twist, it is Davis’ “first integrative pharmacy, bridging traditional pharmacy services with complementary alternative medicine,” its website says. Custom compounded medications are a specialty. Pharmacists prepare the drug in a more palatable form or to avoid ingredients that cause allergic reactions.
Employees told me that owner Brad Brazill, a pharmacist and professor, was out of town. He didn’t respond to my messages and emails. Customers’ files are being transferred to the Rite Aid in South Davis, customers say.
El Macero Pharmacy is at 417 Mace Blvd., Suite D, near the South Davis Nugget.
quoted from here
- April 25, 2014 No comments:
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Thursday, April 24, 2014

Pet Script, Inc's Paris, TX FDA 483 Issued in 2004

Pet Script, Inc's Paris, TX site has been inspected 1 time since 08/02 - 08/16/2004. The most recent FDA audit (that FDAzilla knows about) occurred on 08/02 - 08/16/2004.
The FDA has issued 1 Form 483 inspectional observations.

Pet Script, Inc
3160 Clarksville St
Paris, TX
 Hunt, Tamera H   Ziegler, Sandy J 
08/02 - 08/16/2004
Buy this 483
- April 24, 2014 No comments:
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Racing Free Talk: RF Report- "In This Industry: Being Proactive is N...

Racing Free Talk: RF Report- "In This Industry: Being Proactive is N...: “In This Industry: Being Proactive is Necessary” Remington Park and Racing Free Encourage Horsemen to be Proactive in 2014 GUTHRIE...
- April 24, 2014 No comments:
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AAEP Report on Compounded Drugs: Review of Fatalities and Adverse Reactions After Administration of -2 Adrenergic Agonist Reversal Agents in the Horse

 
David B. Scofield, DVM; Dana L. Alexander, BS;

Robert P. Franklin, DVM, Diplomate ACVIM; and

Joseph J. Bertone, DVM, MS, Diplomate ACVIM

read report here


- April 24, 2014 No comments:
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Question of the Day April 24, 2014 Does anyone know the outcome of the August 2004 FDA inspection of Pet Script Inc. in Paris, Texas?

source showing inspection found here
- April 24, 2014 No comments:
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Absolute Must Read! Letter Dated February 18, 2014 Very Interesting Information Regarding Compounding Pharmacies

docs.house.gov

docs.house.gov/meetings/IF/IF14/20130716/101137/HHRG-113-IF14-W...
1 These 226 inspections represent the number of inspections recorded under the human and veterinary pharmacy compounding ... Compounding Pharmacy LLC, Weatherford ...
- April 24, 2014 No comments:
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Plaintiffs Seek to Keep Clinics in Tainted Steroid MDL


Amaris Elliott-Engel, The National Law Journal

Read more: http://www.nationallawjournal.com/id=1202649240978/Plaintiffs-Seek-to-Keep-Clinics-in-Tainted-Steroid-MDL#ixzz2zraybRhY
- April 24, 2014 No comments:
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This blog is not affiliated with any company nor does it or has it ever represented any particular company's views. The opinions expressed in this blog are those solely of the author unless indicated otherwise.Nothing contained on this Blog shall constitute legal advice nor be construed as a representation to be reasonably relied upon. This blog site is published by and reflects the personal views of the Author. No representation is made about the accuracy of the information, which solely constitutes the Author’s personal view on these issues. The information contained in this blog site is provided only as general information and personal opinions, and blog topics may or may not be updated after being initially posted. To make informed legal decisions, you should always consult with your own lawyer for your personal legal needs.

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