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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, July 20, 2018
Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA Statement from Commissioner Scott Gottlieb, M.D.; Peter Marks, M.D., Ph.D., director, Center for Biologics Evaluation and Research; and Janet Woodcock, M.D., director, Center for Drug Evaluation and Research
New charges filed in New England Compounding Center case
| New charges filed in New England Compounding Center case
Federal prosecutors have charged another person in the sprawling New England Compounding Center case, accusing a former pharmacy buyer at a ...
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High Importance!! USP tackles 'hot mess' — veterinary compounding
| USP tackles 'hot mess' — veterinary compounding
Timeline for U.S. Pharmacopeia recommendations on hazardous drugs and compounded preparations Veterinary compounding in the United States ..
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FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents, including hard-to-copy complex generics and abuse-deterrent formulations of opioids
The U.S. Food and Drug Administration today announced a new batch of product-specific guidances to support industry in identifying appropriate science-based methodologies and evidence for developing generic drugs. The batch contains 43 product-specific guidances, including 26 new guidances and 17 revised guidances that, when finalized, will describe the FDA’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their respective reference-listed drugs.
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse
One of the ways that the U.S. Food and Drug Administration is working to address the opioid epidemic is by encouraging the development of opioid analgesic products that are harder to manipulate and abuse. Opioids with abuse-deterrent formulations (ADFs) are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding.
These innovative formulations are designed to make it harder for people to manipulate the opioid product so they can’t be as easily abused to deliver an immediate “high.” But it’s important that prescribers and patients understand that these drugs are not “abuse-proof,” and they do not prevent addiction, overdose or death.
Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed
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State pharmacy board director allegedly offered job in exchange for controversial medical marijuana rule
State pharmacy board director allegedly offered job in exchange for controversial
Wednesday, July 18, 2018
Brentwood Brothers Face Prison For Bogus Pharmacy Compounding Drug Pedaling
Brentwood Brothers Face Prison For Bogus Pharmacy Drug Pedaling
Patch.com-32 minutes ago
Dalibor "Dabo" Kabov and his older brother Berry -- operators of Global CompoundingPharmacy -- were convicted in January 2017 of being at the center of a ..
CareZone sues Express Scripts for defamation following contract fight
FierceHealthcare-18 hours ago
A mounting battle between Express Scripts and online pharmacy CareZone just got a little more heated. Weeks after CareZone accused Express Scripts of ...
Amazon eyes India pharmacy space, to invest in pharmacy chain ...
Entrackr-Jul 16, 2018
US e-tailer major Amazon is in early talks to invest in India's second largest pharmacychain Medplus. Amazon, which considers India to be one of its key ...
Amazon's Reach Now Extends To Pharmacies
Global Finance-12 hours ago
Online marketplace Amazon disrupted the entire pharmacy industry—for a day at least—with its $1 billion purchase of PillPack, an online pharmacy that uses ...
Wedgewood Pharmacy and Diamondback Drugs Animal-Health ...
Arizona Daily Star-10 hours ago
As the top compounding pharmacy in the U.S., the new, combined company ... pharmacy to become the largest animal-health compounding pharmacy in the.
| 06/27/2018 | 3012289984 | Well Care Discount Pharmacy, LLC | 483 | NV | Producer of Sterile Drug Products | 07/17/2018 |
| 07/02/2018 | 3003780900 | People’s Custom Rx and Clinical Care, LLC | 483 | TN | Producer of Sterile Drug Products | 07/16/2018 |
| 07/03/2018 | AniCell Biotech | Los Angeles District Office | Unapproved New Animal Drug/Adultered | Not Issued * |
| 07/03/2018 | bB BioChem Laboratories Inc. | Los Angeles District Office | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | Not Issued * |
| 07/05/2018 | Claris Injectables Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
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