FDA Warning Letter dated February 19, 2014 to Pallimed Solutions, Inc.

February 19, 2014

Pallimed Solutions, Inc.36

New England District Office

CGMP/Drugs/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

Not Issued

More Information on Imprimis Pharmaceuticals formerly known as Transdel Pharmaceuticals, Inc.

Imprimis Pharmaceuticals, Inc. operates as a specialty pharmaceutical company focusing on the commercial development of compounded drug formulations. The company, through a strategic relationship with Professional Compounding Centers of America, Inc., expects to use its proprietary Accudel drug delivery technology, coupled with licensed technologies, and proprietary formulations and market data, to facilitate its future selection, formulation, and development of potential product candidates. The company is also internally developing non-invasive, topically delivered products. Its patented Accudel cream formulation technology is designed to enable highly targeted site-specific treatment. The companys lead Phase III pain product candidate, Impracor, utilizes the Accudel platform technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug, through the skin directly into the underlying tissues where the drug exerts its localized anti-inflammatory and analgesic effects. It intends to leverage the Accudel platform technology to expand and create a portfolio of topical products for various indications. The company was formerly known as Transdel Pharmaceuticals, Inc. and changed its name to Imprimis Pharmaceuticals, Inc. in February 2012. Imprimis Pharmaceuticals, Inc. was founded in 1998 and is headquartered in San Diego, California.

read here

IACP: IACP AdvanCE Webinar, “Endotoxin Testing and Environmental Monitoring for Your Pharmacy,” presented by William A. Stuart, RPh, Hartley Medical Center Pharmacy, Inc.

 

Register today for the Jan 22 IACP AdvanCE Webinar, “Endotoxin Testing and Environmental Monitoring for Your Pharmacy,” presented by William A. Stuart, RPh, Hartley Medical Center Pharmacy, Inc. This one-hour webinar will provide new technologies for endotoxin testing, how to implement USP <797&...more http://bit.ly/1hTOZLr This program is made possible through an unrestricted educational grant-in-aid from Associates of Cape Cod, Inc.

Pegasus Laboratories, Inc v. US Compounding, Inc. for Patent Infringement in Eastern District of Arkansas

Date	#	Docket Text
1/9/2014	3	MOTION for Leave to Appear pro hac vice by R. Cameron Garrison. Fee $100 receipt number 0860-2366950. Filed by Pegasus Laboratories, Inc (Stevenson, Laurel) (Entered: 01/09/2014)
1/9/2014	2	MOTION for Order (Motion for Appointment of Special Process Server) by Pegasus Laboratories, Inc (Stevenson, Laurel) (Entered: 01/09/2014)
1/8/2014	1	COMPLAINT with Jury Demand against US Compounding, Inc (Filing Fee of $ 400, Receipt #LIT 043828), filed by Pegasus Laboratories, Inc. Summons not issued. (Attachments: # 1 Civil Cover Sheet)(mcz) (Entered: 01/09/2014) RFC Case Number: P-P14-14U Court Case Number: 4:14-cv-00014-JLH File Date: Wednesday, January 08, 2014 Plaintiff: Pegasus Laboratories, Inc Plaintiff Counsel: Laurel Elizabeth Stevenson, R. Cameron Garrison of Lathrop & Gage LLP Defendant: US Compounding, Inc Cause: 35:271 Patent Infringement Court: Arkansas Eastern District Court Judge: Judge J. Leon Holmes Notes:

FDA 483 Pine Pharmacy and Home Care Products Center, Inc., Williamsville, NY

Pine Pharmacy and Home Care Products Center, Inc., Williamsville, NY

• 483 Issued 12/16/2013⁹¹ (PDF – 5.3MB)
• 483 Issued 7/19/2013⁹² (PDF – 1.4MB)

Park and King Pharmacy, Inc. fails to respond to Indiana Board of Pharmacy Request for Information regarding compounding: Board approves final order

C. In the Matter of the Indiana Non-Resident Pharmacy Permit of Park and King Pharmacy,
Inc.
Certification No. 64000990A
Administrative Cause No. 2013 IBP 0083
Regarding Appeal of Findings of Fact, Ultimate Findings of Fact, Conclusions of Law
and Order filed 9/13/13
Parties Present Did not appear
Counsel Present Randy Fearnow, Counsel for Respondent
Darren R. Covington, Deputy Attorney General - Office of the Attorney
General
Participating Board Sara St. Angelo, PharmD., R.Ph., President Members Steven Anderson, R.Ph., Vice President
Winnie Landis, R.Ph., Member
Donna S. Wall, PharmD., R.Ph., Member
William J. Cover, R.Ph., Member
Del T. Fanning, R.Ph., Member

Witnesses for the
Petitioner
None
Witnesses for the State None
Case Summary Pharmacy moved its headquarters, and failed to notify the board that it
had done so. Pharmacy failed to respond to the request for information
regarding its compounding practices, failed to appear for the hearing, and
the license was subsequently disciplined.
Board Action A motion was made by Member Cover and seconded by Member
Anderson to uphold the final order filed 09/13/2013.
Vote Motion Carried 6-0-0

quoted from here

Florida Board of Pharmacy accepts Voluntary Relinquishment Motion from Las Mercedes Drug Store, Inc.

Las Mercedes Drug Store, Inc., PH 25947 – Miami, FL
Case No. 2013-01125 – PCP Risch/Mesaros

The Department suggests that the Board entertain a Motion Accepting the Voluntary Relinquishment
executed by Respondent in resolution of this case.
Motion: by Dr. Weizer, seconded by Mrs. Glass, to accept the Voluntary Relinquishment. Motion
carried.

quoted from Minutes from December 3-4, 2013

Alabama State Board of Pharmacy Disciplined BIRMINGHAM APOTHECARY, INC., #101560 Violated provisions of Alabama Pharmacy Practice Act; assessed monetary fine of $6,000.00.

Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic v. Lowlite Investments, Inc., d/b/a Olympia Pharmacy Has Been Dismissed

09/19/2013	18	STIPULATION of Dismissal by Lowlite Investments Inc, Mark W Sturdy. (Clark, Dulijaza) (Entered: 09/19/2013)
09/26/2013		TEXT ORDER: Pursuant to Rule 41(a)(1)(A)(ii) of the Federal Rules of Civil Procedure, the Parties' Stipulation to Dismiss 18 is ALLOWED. The Clerk is Directed to terminate this case. All pending motions 4 , 14 are DENIED AS MOOT. Entered by Judge Richard Mills on 9/26/13. (ME, ilcd) (Entered: 09/26/2013)

FDA Issues another 483 on Contract Testing Lab: Boston Analytical, Inc., Salem, NH

ARL Biopharma, Inc. dba Analytical Research Laboratories, Oklahoma City, OK

• 483 Issued 11/8/2012 (PDF - 382KB)

Boston Analytical, Inc., Salem, NH

• 483 Issued 11/9/2012 (PDF - 490KB)
   

Dyna Labs, LLC, St. Louis, MO

• 483 Issued 11/13/2012 (PDF - 1MB)

Eagle Analytical Services, Houston, TX

• 483 Issued 6/17/2013 (PDF - 984KB)
   

Front Range Laboratories, Inc., Loveland, CO

• CDER Statement: FDA Alerts Pharmacies to Concerns with Testing Conducted by Front Range Laboratories (8/21/2013)
• FDA Letter to Front Range Customers (PDF – 65KB)”
• 483 Issued 8/30/2013 (PDF - 1.6MB)

Pharmagen Laboratories, Inc., Stamford, CT 483 and Amended 483

• Pharmagen Laboratories, Inc, Stamford, CT, Amended 483 Issued 08/26/2013 (PDF - 1.1MB)
• Pharmagen Laboratories, Inc, Stamford, CT, 483 Issued 08/23/2013 (PDF - 1.1MB)

The Compounding Shop, Inc., St. Petersburg, FL more recent 483 issued 9/3/2013 along with two other 483s

• The Compounding Shop, Inc., St. Petersburg, FL, 483 Issued 9/3/2013 (PDF - 97KB)
• The Compounding Shop St. Petersburg, FL, 483 Issued 3/22/2013 (PDF - 1.3MB)
• The Compounding Shop St. Petersburg, FL, Amended 483 Issued 3/25/2013 (PDF - 10MB)

DEA Order dated September 8, 2013 Affirming Order of Immediate Suspension of Registration issued to S & S Pharmacy, Inc., d/b/a Platinum Pharmacy & Compounding

view order here

CDER Statement Regarding Front Range Laboratories, Inc., Loveland, CO

Front Range Laboratories, Inc., Loveland, CO

• CDER Statement: FDA Alerts Pharmacies to Concerns with Testing Conducted by Front Range Laboratories (8/21/2013)
• FDA Letter to Front Range Customers (PDF – 65KB)”
• 483 Issued 8/30/2013 (PDF - 1.6MB)

Fifth Question of the Day September 7, 2013 How will Imprimis Pharmaceuticals, Inc. with its exclusive relationship with PCCA to commercialize compounded drug formulations utilizing the FDA 505(b)(2) drug develop and predicted to become a large pharmaceutical company in a relatively short period of time impact compounding pharmacies?

For more information on Imprimis --

News

Imprimis' Platform Set To Bring Library Drug Formulations Quickly To Market

By M.E. Garza: Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) has seen its stock rise from about $5.25 per share in February at the time of the NASDAQ listing to around $9 per share and is one of the...

Imprimis acquires intellectual property from Novel Drug Solutions, Eye Care Northwest

Imprimis Pharmaceuticals, focused on the commercialization of drug formulations through a growing proprietary network of compounding pharmacy relationships, has acquired intellectual property from Nov...

Imprimis to begin IRB-approved Impracor Phase III trial for acute pain associated with OA of the knee

Imprimis Pharmaceuticals, Inc., which is focused on the commercialization of compounded drug formulations utilizing the FDA 505(b)(2) development pathway, today announced it has received IRB approval...

Imprimis Pharmaceuticals, Inc. to Present at the Southern California Investor Conference on Thursday, August 8, 2013 at the Island Hotel in Newport Beach, CA. The presentation is scheduled to begin at 11 a.m. ET / 8 a.m. PT

SAN DIEGO, Aug. 5, 2013 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ:IMMY), which is focused on the commercialization of compounded drug formulations utilizing the FDA 505(b)(2) drug develop...

Imprimis to initiate phase III study of drug formulation Impracor

Imprimis Pharmaceuticals has received approval from the Institutional Review Board (IRB) to initiate Phase III clinical trial protocol of its new topical non-steroidal anti-inflammatory drug (NSAID) c...

Imprimis Pharmaceuticals acquires Buderer intellectual property assets

Imprimis Pharmaceuticals has acquired the intellectual property (IP) rights related to proprietary innovations from the compounding pharmacy operations of Ohio-based Buderer Drug, a compounding pharma...

Imprimis Management Discovers And Adds Significant Value In Bankrupt Company Restart

By MarketScanners:Wall Street is littered with failed companies that had great business plans, but did not have management capable of fulfilling the plan's promise. Good investors know management team...

Imprimis acquires IP rights to ophthalmic compound

USA-based Imprimis Pharmaceuticals (Nasdaq: IMMY), which is focused on the commercialization of drug formulations through a growing proprietary network of compounding pharmacy relationships and by uti...

AnazaoHealth Acquires One Stop Pharmacy, Inc.

[08/07/2013]  AnazaoHealth Acquires One Stop Pharmacy, Inc.

Contact AnazaoHealth Corporation, Tampa, FL Doug Berkoff Vice President, CFO 800.995.4363 dberkoff@anazaohealth.com     AnazaoHealth Corporation has acquired One Stop Pharmacy, Inc.  Tampa, FL —July 8, 2013— AnazaoHealth Corporation announced today that it has acquired One Stop Pharmacy, Inc.’s weight loss, age management, and aesthetic lines of business. Both high-quality compounding pharmacies, One Stop Pharmacy and AnazaoHealth, provide patient-specific compounded medications not commercially available for aesthetics, age management and weight loss. In addition, AnazaoHealth provideschelation, men and women’s Health, nutritional supplements, vitamin & mineral compounded medications.   “We look forward to serving One Stop Pharmacy’s customers with the same high-quality medications that they are accustomed to receiving,” stated Chris Arnette, President and Chief Operating Officer of AnazaoHealth. As a PCAB accredited compounding pharmacy, we are dedicated to protecting our patients by providing safe, high-quality compounded preparations.”   About One Stop Pharmacy, Inc. One Stop Pharmacy is a full-service Florida pharmacy dedicated to the preparation of compounded medications. With 38 years of combined compounding experience, the staff has a reputation among physicians by providing medications and advice that make a difference in the lives of their patients.    About AnazaoHealth Corporation AnazaoHealth, headquartered in Tampa, Florida, focuses on patient-specific preparations serving the nuclear medicine, pain management and custom pharmacy markets, as well as providing drugs used in clinical trials. AnazaoHealth is organized around four prescription and service divisions: Nuclear Medicine, Custom Pharmacy, Pain Management, and Brachytherapy. AnazaoHealth, in its 46,000 square foot pharmacy located in Tampa, with an additional pharmacy in Las Vegas, NV, specializes in compounding sterile preparations and is appropriately licensed to provide nuclear, radioactive materials and DEA controlled substances in all 50 states, and the District of Columbia. Visit the AnazaoHealth web site atwww.anazaohealth.com.

Return

COMPLAINT IN DR. MARK W. STURDY d/b/a )ROCHESTER VETERINARY CLINIC on behalf of itself and a class, Plaintiff, v. LOWLITE INVESTMENTS, INC., doing business as OLYMPIA PHARMACY, and JOHN DOES 1-10,

The Complaint  alleges that Lowlite/Olympia violated plaintiff's (a class action-too numerous to name) rights in sending or causing the sending of unsolicited advertisements to telephone
facsimile machines in violation of the Telephone Consumer Protection Act, 47 U.S.C. §227
(“TCPA”), the Illinois Consumer Fraud Act, 815 ILCS 505/2 (“ICFA”), and the common law.  The advertisement of course was for compounded medications.  See exhibit A to complaint.  This will be a very interesting case to watch develop.

Lowlite/Olympia Has Recently Been Sued--Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic v. Lowlite Investments, Inc., d/b/a Olympia Pharmacy and John Does 1-10

filed April 30, 2013, Case Number 3:2013cv03126. Here is docket summary.  Will post copy of complaint soon. Date Filed # Docket Text 04/30/2013 1  COMPLAINT against John Does 1-10, Lowlite Investments, Inc., d/b/a Olympia Pharmacy ( Filing fee $ 350 receipt number 0753-1579273.), filed by Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. (Attachments: # 1 Exhibit A, # 2 Civil Cover Sheet, # 3 Summons)(Edelman, Daniel) (Entered: 04/30/2013) 04/30/2013 2  NOTICE of Appearance of Attorney by Daniel A Edelman on behalf of Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic (Edelman, Daniel) (Entered: 04/30/2013) 04/30/2013 3  NOTICE of Appearance of Attorney by Dulijaza Julie Clark on behalf of Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic (Clark, Dulijaza) (Entered: 04/30/2013) 04/30/2013 4  MOTION to Certify Class by Plaintiff Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. Responses due by 5/17/2013 (Edelman, Daniel) (Entered: 04/30/2013) 04/30/2013 5  MEMORANDUM in Support re 4 MOTION to Certify Class filed by Plaintiff Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. (Attachments: # 1 Exhibit A, # 2 Exhibit B)(Edelman, Daniel) (Entered: 04/30/2013) 04/30/2013 6  NOTICE of Appearance of Attorney by Michelle R Teggelaar on behalf of Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic (Teggelaar, Michelle) (Entered: 04/30/2013) 04/30/2013 7  MOTION to Continue and enter Plaintiff's Motion for Class Certification by Plaintiff Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. Responses due by 5/17/2013 (Clark, Dulijaza) (Entered: 04/30/2013) 05/02/2013    TEXT ORDER by Magistrate Judge Byron Cudmore: Plaintiff's Motion to Enter and Continue Plaintiff's Motion for Class Certification 7 ALLOWED in that Plaintiff's Motion for Class Certification 4 will remain of record and taken under advisement until the parties are at issue. The ECF response date from Motion 4 is stricken. Plaintiff to take steps to serve Defendants. (LB, ilcd) (Entered: 05/02/2013) 05/15/2013 8  Summons Issued as to Lowlite Investments Inc.. Original returned to attorney for service. (MJ, ilcd) (Entered: 05/15/2013)

Apothecary Shop of Phoenix, Inc also Discplined by Arizonia Board of Pharmacy

Y003155	Apothecary Shop of Phoenix, Inc.	03-0015 CONSENT AGREEMENT
	Apothecary Shop of Phoenix, Inc.	03-0015 AMENDED COMPLAINT
	Apothecary Shop of Phoenix, Inc.	03-0015 FINDINGS OF FACT

Florida Shuts Down N.W. Pharmacy, Inc.--parenteral/enteral compounding pharmacy

This ESO (Emergency Suspension Order) where pharmacy has been shut down.  Thank you to Kenneth N. Woliner, M.D., A.B.F.M.,Holistic Family Medicine, LLC, www.holisticfamilymed.com for bringing to my attention

http://ww2.doh.state.fl.us/DocServiceMngr/GetImage.aspx?documentid=MTc0NzQxOTc=&enc=1