Manufacturing and Compounding
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USP 800 and FDA cGMP: New Regulations for Compounding Pharmacies

This webinar provides an overview of the current and future regulatory landscape for pharmaceutical compounders, with a focus on how this impacts cleanroo
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Compounding Pharmacy Global Market Will Experience Robust Growth Through 2021

Compounding Pharmacy Global Market Will Experience Robust Growth Through 2021 | Manufacturing and Compounding | Scoop.it
The compounding pharmacy global market promises to continue to experience robust growth through 2021.
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Drug regulator seeks to amend pharma manufacturing laws - Livemint

Drug regulator seeks to amend pharma manufacturing laws - Livemint | Manufacturing and Compounding | Scoop.it
DCGI to move a proposal before the govt within next six months to amend Drugs and Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945
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Drug regulator seeks to amend pharma manufacturing laws - Livemint

Drug regulator seeks to amend pharma manufacturing laws - Livemint | Manufacturing and Compounding | Scoop.it
DCGI to move a proposal before the govt within next six months to amend Drugs and Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945
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Proposed New FDA Office Eyes Drug Manufacturing Metrics - Bloomberg Government

Proposed New FDA Office Eyes Drug Manufacturing Metrics - Bloomberg Government | Manufacturing and Compounding | Scoop.it
(Bloomberg) — The Food and Drug Administration is ramping up preparations for a proposed a new division, the Office of Pharmaceutical Quality (OPQ), within its... (Who's Watching Your Drugs?
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Memphis pharmacies brace as Express Scripts targets compounding drugs - Insurance News Net - Pharmacy - NewsLocker

Memphis pharmacies brace as Express Scripts targets compounding drugs - Insurance News Net - Pharmacy - NewsLocker | Manufacturing and Compounding | Scoop.it
Memphis pharmacies brace as Express Scripts targets compounding drugs
Insurance News Net
St.
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FDA Once Again Warns Against Compounding Pharmacy - Controlled Environments Magazine

FDA Once Again Warns Against Compounding Pharmacy - Controlled Environments Magazine | Manufacturing and Compounding | Scoop.it
FDA Once Again Warns Against Compounding Pharmacy
Controlled Environments Magazine
The U.S.
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FDA Clarifies how Generic Drug Companies can Change Their Manufacturing ... - Regulatory Focus

FDA Clarifies how Generic Drug Companies can Change Their Manufacturing ... - Regulatory Focus | Manufacturing and Compounding | Scoop.it
Regulatory Focus
FDA Clarifies how Generic Drug Companies can Change Their Manufacturing ...
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Compounding Pharmacy Issues Recall, But Challenges FDA Decision - Pharmaceutical Technology Magazine

Compounding Pharmacy Issues Recall, But Challenges FDA Decision Pharmaceutical Technology Magazine FDA has posted on www.fda.gov a July 19, 2014 press statement from Unique Pharmaceuticals, which reports a voluntary nationwide recall of all sterile...
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FDA Offers Warning About Compounding Pharmacy; More On Sovaldi

FDA Offers Warning About Compounding Pharmacy; More On Sovaldi | Manufacturing and Compounding | Scoop.it
This latest warning is the Food and Drug Administration's third in 15 months. The Wall Street Journal's Pharmalot: FDA Spars With Recalcitrant Compounding Pharmacy, Again For the third time in 15 months, the FDA is ...
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Custom-drug makers to come under voluntary oversight - Arizona Republic

Custom-drug makers to come under voluntary oversight - Arizona Republic | Manufacturing and Compounding | Scoop.it
Custom-drug makers to come under voluntary oversight
Arizona Republic
The outbreak underscored lax regulation of drug-compounding facilities, which manufacture unique combinations of medicines for specific conditions and illnesses.
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Careful Compounding | TheHorse.com

Careful Compounding | TheHorse.com | Manufacturing and Compounding | Scoop.it
Compounding, the practice of changing the preparation, strength, or even flavor of a drug to meet a particular therapeutic requirement for a specific patient, is a long-established practice in veterinary medicine.
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Preparing for a State Board of Pharmacy Compounding Practice Inspection

Preparing for a State Board of Pharmacy Compounding Practice Inspection | Manufacturing and Compounding | Scoop.it
This activity provides compounding pharmacists and technicians the tools to develop the necessary
competence to prepare for licensure for a compounding practice with respect to a State Board of Pharmacy inspection.
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Compounding in a nutshell

It'S the satisfaction of handing a parent a medication that will put a child at ease that's the main motivator for Scott Street Pharmacy's Sonja Venzke. W
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What do the first 3D-printed pills mean for the future of drug companies? - Mashable

What do the first 3D-printed pills mean for the future of drug companies? - Mashable | Manufacturing and Compounding | Scoop.it
The FDA just approved the first pill produced by the technique, but historians say the manufacturing process probably won’t threaten big drug companies.
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Park Compounding Pharmacy FDA statement - Lack of sterility assurance - IVTEAM - Intravenous therapy news and product updates

Park Compounding Pharmacy FDA statement - Lack of sterility assurance - IVTEAM - Intravenous therapy news and product updates | Manufacturing and Compounding | Scoop.it
Park Compounding Pharmacy FDA statement - Lack of sterility assurance
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Sen. Keenan leads pharmacy oversight reform - Wicked Local Abington

Sen. Keenan leads pharmacy oversight reform - Wicked Local Abington | Manufacturing and Compounding | Scoop.it
Sen. Keenan leads pharmacy oversight reform Wicked Local Abington The State Legislature recently took final action on a bill that creates new regulations and limitations on the practice of pharmacy compounding in Massachusetts, after a committee of...
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FDA Continues To Bolster Regulation Of Compounding Pharmacies - Mondaq News Alerts (registration)

FDA Continues To Bolster Regulation Of Compounding Pharmacies - Mondaq News Alerts (registration) | Manufacturing and Compounding | Scoop.it
FDA Continues To Bolster Regulation Of Compounding Pharmacies Mondaq News Alerts (registration) Armed with new authority granted by the Drug Quality and Security Act ("DQSA"), FDA is increasingly using its regulatory powers to enhance oversight of...
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Pharma SMEs may cut down contract manufacturing of DPCO drugs - Business Standard

Pharma SMEs may cut down contract manufacturing of DPCO drugs Business Standard As the domestic pharma industry receives a bolt from the blue with 108 more drugs coming under price control as per the latest notification of the National...
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Laminated Particleboard not a Great Idea for Sterile Compounding, FDA says in ... - Regulatory Focus

Laminated Particleboard not a Great Idea for Sterile Compounding, FDA says in ... - Regulatory Focus | Manufacturing and Compounding | Scoop.it
Regulatory Focus
Laminated Particleboard not a Great Idea for Sterile Compounding, FDA says in ...
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America's Execution Problem - TIME

America's Execution Problem - TIME | Manufacturing and Compounding | Scoop.it
ABC News
America's Execution Problem
TIME
But the drugs used for the long-established protocol have been increasingly hard to come by as pharmaceutical companies balk for ethical reasons.
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Ipca Labs stops API export to US as FDA finds fault at Ratlam unit - Economic Times

Ipca Labs stops API export to US as FDA finds fault at Ratlam unit - Economic Times | Manufacturing and Compounding | Scoop.it
Economic Times Ipca Labs stops API export to US as FDA finds fault at Ratlam unit Economic Times During the recent US food and Drug Administration (USFDA) inspection at the company's API manufacturing unit at Ratlam in Madhya Pradesh, the company...
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Pharmacy Investigated After Horse Deaths - LEX18 Lexington KY News

Pharmacy Investigated After Horse Deaths - LEX18 Lexington KY News | Manufacturing and Compounding | Scoop.it
Pharmacy Investigated After Horse Deaths
LEX18 Lexington KY News
The Lexington pharmaceutical company, Wickliffe, is under investigation by the FDA for their compounded EPM drug.
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Dangers from compounding pharmacies persist

Dangers from compounding pharmacies persist | Manufacturing and Compounding | Scoop.it
Nearly a year after a nationwide outbreak of fungal meningitis erupted, new cases of the disease are still emerging, and efforts to tighten regulation of the type of pharmacy behind the outbreak are moving slowly.

Via Dr. Anas Bahnassi
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