The Law of Compounding Medications And Drugs: August 2019

Purdue Pharma has reportedly offered up to $12 billion to resolve thousands of opioid lawsuits. The company would hand over some cash and drug royalties and declare bankruptcy, while the Sackler family would pay $3 billion, media reports say.

Indian API maker hosed by FDA over contamination potential

Tuesday, August 27, 2019

FDA requests recall of sterile compounded drug products produced by Pacifico National Inc., dba AmEx Pharmacy, reminds patients and health care professionals to stop using due to potential risks

The U.S. Food and Drug Administration is reminding patients and health care professionals not to use drug products intended to be sterile made by Pacifico National Inc., an outsourcing facility doing business as AmEx Pharmacy, in Melbourne, Florida. The drugs—which include compounded ophthalmic products among other drug products — pose unnecessary risks due to significant quality and sterility concerns.

“When the FDA becomes aware of drugs that have the potential to cause harm to American consumers, we will alert the public, Prior to today’s outreach, AmEx Pharmacy refused to recall all sterile drug products and has not adequately addressed FDA’s concern that it is manufacturing drugs that are not in line with the quality standards we’ve set, putting patients at risk,” said Acting FDA Commissioner Ned Sharpless, M.D. “We urge drug manufacturers and compounders to take appropriate action to ensure quality medicines as the agency continues our efforts to protect public health.”

An FDA inspection of AmEx Pharmacy’s facility found conditions that could cause the company’s drugs to become contaminated or otherwise pose risks to patients. As a result, the agency recommended on June 25that AmEx Pharmacy voluntarily recall all unexpired drugs intended to be ...

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08/27/2019	08/15/2019	H & A Walters Fulfillment Center	Center for Food Safety and Applied Nutrition	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated

08/27/2019	08/13/2019	Ningbo Pulisi Daily Chemical Products Co., Ltd	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated/Misbranded

08/27/2019	07/12/2019	CTX Lifesciences Private Ltd.	Center for Drug Evaluation and Research	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Monday, August 26, 2019

‘Unsafe’ HRT drugs from private clinics sparks warning from experts

https://heraldpublicist.com/unsafe-hrt-drugs-from-private-clinics-sparks-warning-from-experts/

Menopause experts say compounded HRT is unsafe Women told not to use cBHRT because of concerns over ‘purity, potency and safety’

https://www.theguardian.com/society/2019/aug/26/menopause-experts-say-compounded-hrt-is-unsafe

The lawsuits that could bankrupt the opioid industry Bill Whitaker 2 hrs ago

https://www.msn.com/en-us/news/us/the-lawsuits-that-could-bankrupt-the-opioid-industry/ar-AAGmEJE?ocid=spartandhp

Oklahoma: Johnson & Johnson Ordered to Pay $572 Million in Landmark Opioid Trial Jan Hoffman

https://www.msn.com/en-us/money/companies/johnson-and-johnson-ordered-to-pay-dollar572-million-in-landmark-opioid-trial/ar-AAGmidu?ocid=spartandhp

Thursday, August 22, 2019

AAFP Calls for FDA Discretion in Compounding Guidance

https://www.aafp.org › news › government-medicine › 20190821fdacompo...

19 hours ago - August 21, 2019 12:09 pm News Staff – Passage of the Drug Quality and Security Act in the wake of a 2012 outbreak of fungal meningitis was a hard-earned victory for public health. But now a policy trickle-down the FDA is considering could unduly restrict family physicians and ...

Tuesday, August 20, 2019

South Jersey woman who recruited state employees in multi-million dollar prescription scam gets 2 years Today 5:36 PM

https://www.nj.com/ocean/2019/08/south-jersey-woman-who-recruited-state-employees-in-multi-million-dollar-prescription-scam-gets-2-years.html

FDA Wins Court Case to Not Put Vasopressin on Compounding List ...

https://www.raps.org/.../fda-wins-court-case-to-not-put-vasopressin-on-co...

4 hours ago - FDA Wins Court Case to Not Put Vasopressin on Compounding List. The US Food and Drug Administration (FDA) has won a case in the US District Court

Since the NECC Outbreak which state has received the most warning letters, 483 etc. from the FDA? Which has received the most referral letters?

WellRx, LLC (dba HomeRx, LLC), Wheaton, IL

Vitalab Pharmacy, Incorporated (dba Vasco Pharmacy), Phoenix, AZ

Warning Letter (01/10/2019)

US Compounding Inc., Conway, AR

483 Issued 02/07/2019 (PDF - 2.11MB)

United Pharmacy, LLC, West Palm Beach, FL

Warning Letter (02/11/2019)

Triad Rx, Inc., Daphne, AL

Warning Letter (02/05/2019)

Total Vein Pharmacy, LLC, (dba Total Vein Pharmacy), Houston, TX

483 Issued 05/09/2019 (PDF - 219KB)

The Wellness Center Pharmacy, Inc., (dba Designer Drugs), Chattanooga, TN

Referral Letter to the Tennessee Board of Pharmacy Issued 02/06/2019 (PDF - 54KB)
FMD-145 Letter Issued 02/06/2019 (PDF - 47KB)

RXQ Compounding, LLC, Athens, OH

Firm Press Release: RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products within Expiry and Voluntarily Cessation of Production Due to the Lack of Sterility Process Assurance (06/18/2019)

Rocky Mountain Pharmacy Inc, Bozeman MT

Warning Letter (05/09/2019)

Ranier’s Compounding Laboratory, Jeannette, PA

FDA Press Release: Federal court enters consent decree against Ranier's Rx Laboratory and owner for manufacturing purportedly sterile drug products in unsanitary conditions (02/06/2019)

QuVa Pharma Inc. Temple, TX

483 Issued 03/14/2019 (PDF - 1.14MB)

Puget Sound Drug Corporation, (dba Key Compounding Pharmacy), Federal Way, WA

483 Issued 06/13/2019 (PDF - 1.27MB)

Professional Arts Pharmacy, Baltimore, MD

Warning Letter CloseOut (03/11/2019)

Premier Pharmacy Labs, Inc., (dba Rx Nations), Weeki Wachee, FL

Firm Press Release: Premier Pharmacy Labs Issues Voluntary Nationwide Recall of all Unexpired Sterile Drug Product Lots Due to Lack of Sterility Assurance (06/18/2019)

Poulsbo Compounding Pharmacy, LLC, (dba Cascade Specialty Pharmacy), Poulsbo, WA

483 Issued 04/17/2019 (PDF - 710KB)

Pinnacle Compounding, Missoula, MT

483 Issued 04/25/2019 (PDF - 278KB)

Pharmacy Resources Incorporated, Denver, CO

483 Issued 01/29/2019 (PDF - 1.2MB)

People's Pharmacy, Inc. #2, Austin, TX

FMD-145 Letter Issued 03/12/2019

Pensacola Apothecary Inc., (dba Everwell Specialty Pharmacy), Pensacola, FL

Warning Letter CloseOut (04/22/2019)

Pacifico National Inc., (dba Amex Pharmacy), Melbourne, FL

483 Issued 05/31/2019 (PDF - 3.11MB)

Option Care Enterprises, Inc., (dba Option Care), Little Rock, AR

483 Issued 03/12/2019 (PDF - 354KB)

One Way Drug, LLC, (dba Partell Specialty Pharmacy), Las Vegas, NV

Warning Letter (03/13/2019)

Millers of Wyckoff, Inc., Wyckoff, NJ

Warning Letter CloseOut (02/26/2019)
FMD-145 Letter Issued 02/26/2019
State Referral Letter Issued 02/26/2019 (PDF - 218KB)

Medcraft LLC, Mounds, OK

FMD-145 Letter Issued 01/30/2019 (PDF - 77KB)

Maplerose Enterprises, LLC (dba Pencol Pharmacy), Denver, CO

483 Issued 02/26/2019 (PDF - 1.9MB)

Lifetime Value Pharmacy III Inc., Santa Ana, CA

483 Issued 02/21/2019 (PDF - 1.9MB)

La Vita Compounding Pharmacy, LLC, San Diego, CA

Warning Letter (02/28/2019)

John's Pharmacy, Inc., Sullivan, IL

483 Issued 02/22/2019 (PDF - 384KB)

Intrathecal Compounding Specialist, LLC, Scott, LA

483 Issued 02/14/2019 (PDF - 417KB)

Infusion Partners, LLC, Canfield, OH

Warning Letter (03/20/2019)

ImprimisRx CA Inc. (dba ImprimisRx), Irvine CA

Warning Letter (03/26/2019)

Health Solutions Pharmacy Center, Inc., Corvallis, OR

483 Issued 01/28/2019 (PDF - 1.3MB)

Guardian Pharmacy Services, Dallas, TX

FDA Press Release: Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services (03/12/2019)

Front Door Pharmacy, LLC, (dba Pure Pharmacy), Houston, TX

483 Issued 03/18/2019 (PDF - 1MB)

Drug Crafters, L.P., Frisco, TX

State Referral Letter Issued 02/11/2019 (PDF - 67KB)

Buderer Drug Company Inc. Perrysburg, OH

Warning Letter CloseOut (05/01/2019)
483 Issued 02/14/2019 (PDF - 268KB)

BMD Skincare, Inc., Canoga Park, CA

483 Issued 03/05/2019 (PDF - 15.6MB)

Bella Pharmaceuticals, Inc.

Warning Letter (02/11/2019)

Firm Press Release External Link Disclaimer: Athenex Provides an Update Regarding the Vasopressin Case (08/02/2019)

ARJ Infusion Services, Inc., Lenexa, KS.

Apollo Care LLC, Columbia, MO

Warning Letter (03/20/2019)

Diplomat Pharmacy, Inc. (dba Diplomat Specialty Pharmacy), Flint, MI

State Referral Letter Issued 02/11/2019 (PDF - 70KB)

Customceutical Compounding, LLC, Phoenix, AZ

483 Issued 03/08/2019 (PDF - 957KB)

CSRX Inc., (dba Rushmore Compounding Pharmacy), Rapid City, SD

FMD-145 Letter Issued 02/19/2019 (PDF - 66KB)

Coram Healthcare Corp. of Indiana, Crown Point, IN

FMD-145 Letter Issued 03/07/2019 (PDF - 89KB)

Compound Care Pharmacy, Louisville, TX

483 Issued 05/16/2019 (PDF - 169KB)

California Specialty Pharmacy, Inc., Whittier, CA

483 Issued 05/17/2019 (PDF - 397KB)

Custom Compounding Center, Little Rock, AR

483 Issued 06/04/2019 (PDF - 196KB)

08/20/2019	08/06/2019	Let's Talk Health, Inc.	Division of Human and Animal Food Operations West V	Unapproved New Drugs/Misbranded

08/20/2019	08/02/2019	NingBo Huize Commodity Co., Ltd.	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated/Misbranded

08/20/2019	08/01/2019	TG United, Inc.	Office of Pharmaceutical Quality Operations, Division II	CGMP/Finished Pharmaceuticals/Adulterated

08/20/2019	07/29/2019	Promise Pharmacy, LLC	Office of Pharmaceutical Quality Operations, Division II	Compounding Pharmacy/Adulterated Drug Products

Monday, August 19, 2019

Legislation and Regulation Committee Chair Report - California State ...

https://www.pharmacy.ca.gov/meetings/agendas/2019/19_jul_leg_mat.pdf

Jul 24, 2019 - Summary: Would require the compounding of drug preparations by a ... Summary: Would update several provisions of pharmacy law including alignment of ...... renewal for a veterinary food-animal drug retailer is three hundred thirty dollars.

Racing Commissioners International

https://arci-members.azurewebsites.net/publicpages/publicrulings.asp

7 hours ago - Ruling Number: 19MDH59, Ruling Type: Medication/Drug Violation - Animal ...... Rule 7890.0110 Subpart 12 - Compounded Medications on Association Grounds ... Attorney at Law, in a Stewards' hearing at Delaware Park on July 26, 2019

pharmacy laws of north carolina - North Carolina Board of Pharmacy

www.ncbop.org/LawsRules/Statutes.pdf

Aug 10, 2019 - This compilation of some of the Pharmacy Laws of North Carolina is provided ..... drug, exclusive of compounding by a drug manufactur