Friday, October 30, 2020

 Wayne Pharmacy; Decision and Order (October 8, 2020)

Heavenly Care Pharmacy; Decision and Order (PDF) (August 28, 2020)

Morning Star Pharmacy & Medical Supply 1; Decision and Order (PDF) (August 19, 2020)

Brewster Drug, Inc.; Decision and Order (April 3, 2020)

What's New from DEA Diversion Control Division

 Final Rule: Implementation of the Combat Methamphetamine Epidemic Act of 2005; Retail Sales; Notice of Transfers Following Importation or Exportation (October 29, 2020)

 

Along with Witches, Time Flies By | Lachman Consultant ...

14 hours ago — Drug products compounded for veterinary use, repackaged drug products, biological products subject to licensure through a biologics license application under 

 

FDA's Final MOU On Interstate Compounding Now Awaits ...

7 hours ago — FDA's Final MOU On Interstate Compounding Now Awaits Signatures From States. Pharmacy Group Says FDA Has Underestimated Amount Of Work For MOU.

 

FDA Announces Availability of the Standard Memorandum of ...

23 hours ago — According to the statute, compounding pharmacies may distribute only 5% of their compounded drugs interstate unless the state in which the pharmacy is ...

 

Lingering Problems With Sterile Compounded Drug ...

15 hours ago — A new survey finds many compounding pharmacies still make dispensing errors despite stringent improvements and requirements put in place over the last ...

Owner of Nicholasville compounding pharmacy pleads guilty in prescription drugs case

/www.wkyt.com/2020/10/29/ownermpounding-pharmacy-pleads-guilty-in-prescription-drugs-case/ 

Wednesday, October 28, 2020

 

Department of Justice Files Complaint Against California Company To Stop Distribution of Adulterated Animal Drugs

The United States filed a civil complaint to stop a California company from manufacturing and distributing adulterated animal drugs, the Department of Justice announced today.

The complaint, filed October 27, seeks a permanent injunction against defendants Med-Pharmex, Inc. (MPX), Gerald P. Macedo, and Vinay M. Rangnekar to prevent them from manufacturing and distributing animal drugs under conditions that fall short of the minimum regulatory requirements to ensure safety and quality. The complaint alleges that multiple inspections by the U.S. Food and Drug Administration (FDA) repeatedly showed that the defendants failed to conform to current good manufacturing practices (cGMPs), including failure to maintain sterility.

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Code of Colorado Regulations - Colorado Secretary of State

7 days ago — prescription drug outlet for the purpose of dispensing a prescription order. (1) ... Compounded prescription drugs distributed to veterinarians for “office ...

 

Lawmakers: DEA math not adding up | 2020-10-26 | BioWorld

1 day ago — Calling it a significant milestone in its drug compounding program, the FDA ... of compounded drugs produced by traditional compounding pharmacies,” FDA .

 

A Guide to FDA's Final Rule on the Importation of Prescription ...

16 hours ago — On September 25, 2020, the U.S. Food and Drug Administration issued a final rule ... imaging drugs; medical gases; homeopathic drugs; compounded drugs).

 

FDA Calls Partnership With States on Compounders a ...

1 day ago — ... the agency and states for regulating traditional compounding pharmacies that ... agree to investigate complaints about drugs compounded at their pharmacies ..

 

FDA-state compounding MOU now available for signing | RAPS

1 day ago — A standard memorandum of understanding between the US Food and Drug Administration (FDA) and the states regarding interstate distribution of compounded 

 

Inter-governmental Working Meeting on Drug Compounding ...

2 days ago — The purpose of this meeting was to discuss oversight of compounding, including implementation of the Title I of the Drug Quality and Security Act (DQSA), and to .

 

Memorandum of Understanding ... - Federal Register

20 hours ago — ... of Understanding Addressing Certain Distributions of Compounded Human ... the FD&C Act entitled “Pharmacy Compounding of Human Drug Products Under 
3 hours ago — FDA announced Monday that a standard memorandum of understanding (MOU) regarding interstate distribution of compounded drugs is now available for

Alliance for Pharmacy Compounding Issues Public Comment on FDA Notice

Alliance for Pharmacy Compounding Issues Public Comment on FDA Notice: Shawn Hodges, president with the Alexandria, Virginia- based Alliance for Pharmacy Compounding, has issued a public comment on the Food and Drug Administration notice entitled Compounding Animal Drugs from Bulk Drug Substances; Guidance for Industry; Draft Guidance. I write today in my role as president of the Alliance for Pharmacy Compounding, formerly the...

Dr. Hahn's Remarks to the Intergovernmental Working Meeting on Drug Compounding OCTOBER 27, 2020

https://www.fda.gov/news-events/speeches-fda-officials/dr-hahns-remarks-intergovernmental-working-meeting-drug-compounding-10272020 

Arizona finds pharmacist to prepare lethal injections

https://www.washingtontimes.com/news/2020/oct/27/official-arizona-finds-pharmacist-to-prep-lethal-i/ 

Tuesday, October 27, 2020