The Law of Compounding Medications And Drugs

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

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Friday, December 30, 2016

Drug industry hired officials from DEA as the agency tried to curb ...

https://www.pharmacist.com/.../drug-industry-hired-officials-dea-agency-tried-curb-o...
4 days ago - The DEA arm is responsible for keeping prescription medications off the black market and is empowered to punish physicians, pharmacies, and drug companies ...
- December 30, 2016 No comments:
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Lawsuits against EpiPen maker Mylan moving forward

Milwaukee Journal Sentinel-8 hours ago
A pharmacist holds a package of EpiPen epinephrine auto-injector, a Mylan product. (Photo: Rich Pedroncelli, AP). Cincinnati. — The maker of the EpiPen that 
- December 30, 2016 No comments:
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Sydney pharmacist and wholesaler has registration cancelled after ...

dailytelegraph.com.au-20 hours ago
SELLING counterfeit Viagra has landed a Glendenning pharmacist in hot water after the dodgy tablets were distributed to the Sydney Children's Hospital.
- December 30, 2016 No comments:
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Pulling Back the Curtain on Diplomat Pharmacy, Inc. (NYSE:DPLO ...

Engelwood Daily-6 hours ago
Wall Street analysts covering Diplomat Pharmacy, Inc. (NYSE:DPLO) shares are predicting that the stock will trade between $14 and $23 within the next year.
- December 30, 2016 No comments:
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MILITARY UPDATE: Point-of-service controls keeping Rx savings on ...

The Northwest Florida Daily News-9 hours ago
The Department of Defense pharmacy program is on to track to slice $1.3 billion off projected drug costs from 2014 to 2019, thanks to higher beneficiary co-pays, ..
- December 30, 2016 No comments:
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Diplomat Pharmacy Enters Oversold Territory

Nasdaq-3 hours ago
In trading on Friday, shares of Diplomat Pharmacy Inc (Symbol: DPLO) entered into oversold territory, hitting an RSI reading of 29.7, after changing hands as low ...
- December 30, 2016 No comments:
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Public trust means pharmacists must be accountable Staunton News Leader-11 hours ago

Public trust means pharmacists must be accountable
Staunton News Leader-11 hours ago
- December 30, 2016 No comments:
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Pharmacy owner pleads guilty in referral scheme; area clinic involved

KWTX-6 hours ago
With his plea before a federal judge in Austin, Brian David Haney, 37, admits paying more than $800,000 to the owner of a chain of clinics who referred patients ...
- December 30, 2016 No comments:
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Behind the $400 Billion Illegal Online Pharmacy Industry

Medscape-10 hours ago
Face-to-face interaction with a pharmacist is the most desirable situation for obtaining medication, but legitimate online pharmacies may offer greater ...
- December 30, 2016 No comments:
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Report on pharmacies prompts changes in data availability

Fredericksburg.com-4 hours ago
Mistakes ranged from sloppy record-keeping to not having the proper environment for compounding drugs. The newspaper, which published its findings in a ...
- December 30, 2016 No comments:
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Arkansas lethal injection drug set to expire, no replacement

wreg.com-2 hours ago
The law says Arkansas can use a one-drug protocol— a barbiturate— or seek drugs from an accredited compounding pharmacy. Arkansas currently has 35 ...
- December 30, 2016 No comments:
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Thursday, December 29, 2016

  • CDER Statement: FDA Issues Draft Guidances on Compounding and Repackaging Radiopharmaceuticals
  • Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 349KB)
  • Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry (PDF - 107KB)
  • Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry (PDF - 122KB)
- December 29, 2016 No comments:
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Wednesday, December 28, 2016

Essential Read! Langham: A Florida Formulary?

Langham: A Florida Formulary?

WorkCompCentral (subscription)-14 hours ago
This process has been the alleged focus of "compounding pharmacies," which combine medications in a particular case, for administration to a particular patient.
- December 28, 2016 1 comment:
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This Month in Corruption: Snapshots of the Public Trust Betrayed

JD Supra (press release)-21 hours ago
... national sales director for the New England Compounding Center (NECC) in ... “Ronzio admitted that NECC was a pharmacy dispensing drugs pursuant to ...
- December 28, 2016 No comments:
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What happens when your hospital pharmacy gets in trouble?

Staunton News Leader-17 hours ago
A surprise inspection of the pharmacy turned up major violations so critical that the hospital was forced to outsource its compounding of sterile fluids and begin ...
- December 28, 2016 No comments:
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Importance of sterile compounding - The News Leader

www.newsleader.com/videos/news/local/2016/12/28/...compounding/94595030/
17 hours ago - John Lubowski, director of pharmacy at Augusta Health, talks about the importance of sterile compounding in a hospital pharmacy. The hospital's on-site ...
- December 28, 2016 No comments:
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Tuesday, December 27, 2016

APhA part of effort targeting illegal online pharmacies

Pharmacy Today, American Pharmacists Association, pharmacist.com-8 hours ago
APhA has partnered with the Alliance for Safe Online Pharmacies (ASOP Global) and 15 other national health care stakeholders to educate providers and 
- December 27, 2016 No comments:
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Hattiesburg pharmacy technician arrested for multiple fraud charges

WDAM-TV-1 minute ago
Attorney General Jim Hood announced Tuesday that a Hattiesburg pharmacy technician has been arrested following a joint investigation by the Health and ...
- December 27, 2016 No comments:
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meningitis-etc: Victims Awaiting Word on Trial Attendance

meningitis-etc: Victims Awaiting Word on Trial Attendance: By Walter F. Roche Jr. With time running out victims of the 2012 fungal meningitis outbreak are awaiting word on whether they will be abl...
- December 27, 2016 No comments:
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meningitis-etc: Judge Denies Cadden Dismissal Motion

meningitis-etc: Judge Denies Cadden Dismissal Motion: By Walter F. Roche Jr. U.S. District Judge Richard G. Stearns has denied a last minute dismissal motion on second degree murder charges ...
- December 27, 2016 No comments:
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Updated List of Registered Outsourcing Facilities as of December 9, 2016

Updated as of 12/9/16
Information Concerning Outsourcing Facility Registration
This table lists the outsourcing facilities that have submitted registration information that has been determined to be complete by the data lock date for the latest weekly update of the table. 
Facility NameInitial Date of Registration as an Outsourcing Facility1Date of Most Recent Registration as an Outsourcing Facility1End Date of Last FDA Inspection Related to Compounding2Was a Form FDA-483 issued?3Other Action, if Any, Based on Last Inspection4,5Intends to Compounds Sterile Drugs From Bulk Drug Substances6
American Specialty Pharmacy, San Antonio, TX12/22/201512/22/2015Not yet inspectedN/AN/AYes
AnazaoHealth Corporation, Las Vegas, NV9/23/201410/18/20161/30/2015YesWarning Letter - 12/9/2015Yes
Auro Pharmacies, Inc, DBA Central Drugs, 511 S. Harbor Blvd, Bldg F, La Habra, CA9/1/201610/19/201612/2/2016YesOpenYes
Avella of Deer Valley, Inc. #38, Phoenix, AZ6/21/201610/8/2016Not yet inspectedN/AN/AN/A
Avella Specialty Pharmacy, Phoenix, AZ2/24/201410/13/20167/31/2015YesOpen7No
Banner Health, Chandler, AZ12/26/201311/23/20163/20/2015YesWarning Letter - 5/5/16No
Bioserv Corporation, San Diego, CA2/23/20162/23/2016Not yet inspectedN/AN/AYes
BSO LLC, Lakewood, CO11/24/201511/7/20169/2/2016YesOpenYes
Brookfield Medical/Surgical Supply, Inc., Brookfield, CT1/12/201512/23/20154/9/2015YesWarning Letter - 7/5/2016Yes
California Pharmacy and Compounding Center, Newport Beach, CA4/30/201411/18/20168/31/2016YesOpen7Yes
Cantrell Drug Company, Little Rock, AR12/16/201310/12/201610/14/2016YesCeased sterile operations and recalled sterile productsYes
Central Admixture Pharmacy Services, Inc., Allentown, PA2/28/201411/3/20169/19/2016YesOpen7Yes
Central Admixture Pharmacy Services, Inc., San Diego, CA
6/4/201411/3/20168/8/2014YesWarning Letter - 8/18/16No
Coastal Meds LLC, Biloxi, MS12/23/201412/6/20169/23/2015YesWarning Letter - 6/22/2016Yes
Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL6/6/201412/31/20158/12/2014YesWarning Letter - 3/10/2016Yes
Delta Pharma, Inc., Ripley, MS8/6/201410/26/20165/24/2016YesOpen7Yes
Eagle Pharmacy, Inc., Birmingham, AL6/16/201510/20/20168/21/2015YesWarning Letter - 10/13/2016Yes
Eaton Veterinary Pharmaceuticals dba Atlas Pharmaceuticals, Phoenix, AZ 11/8/201611/8/2016Not yet inspected N/A N/A Yes 
Edge Pharmacy Services, LLC, Colchester, VT1/21/201411/4/20168/20/2014YesWarning Letter - 11/12/2015Yes
Empower Pharmacy, Houston, TX7/16/201610/13/201611/25/2015YesOpenYes
Exela Pharma Sciences, LLC., Lenoir, NC6/6/20141/12/201611/21/2014YesUntitled Letter - 4/28/2016Yes
Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KS10/2/201510/27/20169/21/2016YesOpenYes
Hybrid Pharma, LLC, Deerfield Beach, FL1/14/201512/24/20157/28/2016YesOpenYes
Imprimis NJOF, LLC, Ledgewood, NJ11/12/201611/12/2016Not yet inspectedN/AN/AN/A
ImprimisRx TX, Inc., Allen, TX4/28/20164/28/2016Not yet inspectedN/AN/AYes
INCELL Corp., LLC, San Antonio, TX  5/29/2015 12/18/2015 9/1/2015YesWarning Letter - 10/28/2016Yes 
Infusion Options Inc., Brooklyn, NY1/24/201412/8/20164/23/2014YesWarning Letter - 3/21/2016No
Isomeric Pharmacy Solutions, LLC, Salt Lake City, UT7/14/201512/31/20156/29/2016YesOpenYes
JCB Laboratories, North Wichita, KS
1/21/201410/27/201612/3/2015YesOpen7Yes
Jubilant HollisterStier LLC, Spokane, WA6/3/201412/31/201512/02/2014YesOpen7Yes
Kings Park Slope, Inc., Brooklyn, NY12/23/201312/31/20154/22/2016YesOpen7Yes
KRS Global Biotechnology, Inc., Boca Raton, FL12/15/201310/27/20158/31/2016YesOpen7Yes
LeeSar, Inc., Fort Myers, FL4/30/201411/11/20168/8/2014YesOpenNo
Leiter's Compounding, 17 Great Oaks Blvd., San Jose, CA1/31/201410/28/201610/7/2014YesWarning Letter - 2/29/2016Yes
Medi-Fare Drug, Blacksburg, SC12/17/201311/9/20169/12/2014YesWarning Letter Closeout - 9/27/2016Yes
Meta Pharmacy Services, Las Vegas, NV10/7/201610/7/2016Not yet inspectedN/AN/AYes
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC7/15/201410/21/20167/6/2016NoOpenYes
Olympia Compounding Pharmacy, Orlando, FL3/10/201411/5/201612/4/2014YesWarning Letter - 2/4/2016Yes
Pacifico National dba Amex Pharmacy, Melbourne, FL9/21/201512/16/20151/21/2016YesOpenYes
Pentec Health, Boothwyn, PA9/21/201611/22/2016Not yet inspectedN/AN/AYes
Pharmaceutic Labs, LLC, Albany, NY3/10/201410/27/20169/23/2015YesOpenYes
Pharmakon Pharmaceuticals, Noblesville, IN1/23/201411/30/20153/16/2016
Yes
Resumed operations after cessation of sterile operations and recall of sterile products7No
Pharm D Solutions, LLC, Houston, TX8/6/201410/25/20166/5/2015YesWarning Letter - 12/8/2016Yes
PharMedium Services, LLC, Cleveland, MS
12/11/201310/11/20167/16/2015
Yes
OpenNo
PharMedium Services, LLC, Dayton. NJ11/3/201510/11/20165/26/2016YesOpenNo
PharMedium Services, LLC, Memphis, TN12/11/201310/17/20167/10/2015
Yes
 
Open
No
PharMedium Services, LLC, Sugar Land, TX
12/11/2013
10/17/2016
9/24/2015
Yes 
Open
No
Pine Pharmaceuticals, LLC, Tonawanda, NY6/17/201412/8/201610/9/2015YesWarning Letter - 11/7/2016Yes
Premier Pharmacy Labs Inc., Brooksville, FL4/16/201410/31/20166/13/2016YesOpen7Yes
Qualgen LLC, formerly registered as Amerilab LLC, Edmond, OK5/23/201411/8/20169/17/2015YesWarning Letter - 6/3/2016Yes
Queens Express Pharmacy, Jackson Heights, NY5/10/201610/14/20167/11/2016YesOpenYes
Quva Pharma, Inc., Sugar Land, TX9/10/201510/12/20162/8/2016Yes (2/5/2016) and (2/8/2016)OpenNo
QuVa Pharma, Inc., Temple, TX12/15/201510/12/201612/8/2016YesOpenYes
RAM Pharma, Inc. Idaho Falls, ID7/21/20167/21/2016Not yet inspectedN/AN/AYes
RC Outsourcing, LLC, Lowellville, OH10/6/201510/25/20162/9/2016Yes (2/9/2016)and (2/25/2016)Closeout Letter - 7/20/2016Yes
Resource Optimization and Innovation, Springfield, MO9/22/201511/24/201511/29/2016YesOpenNo
Right Value Drug Store dba Carie Boyd's Prescription Shop, Hurst, TX1/11/201611/5/201612/12/2014YesWarning Letter - 7/25/2016Yes
RXQ Compounding LLC, Athens, OH1/2/201511/28/20169/21/2015YesWarning Letter - 5/19/2016Yes
SCA Pharmaceuticals, Little Rock, AR
12/13/2013
10/31/2016
4/1/2014
YesWarning Letter - 6/25/2015Yes
Sincerus Florida, LLC, Pompano Beach, FL3/10/201611/30/20167/15/2016YesOpenYes
SSM St. Clare Health Center, Fenton, MO2/18/201410/26/20168/14/2014YesWarning Letter - 10/19/2015No
STERRX, LLC, Plattsburgh, NY  5/29/2015 11/30/2016 Not yet inspected N/A N/A Yes 
Topicare Management LLC, Conroe, TX2/12/20162/12/2016Not yet inspectedN/AN/ANo
Triangle Compounding Pharmacy, Inc., Cary, NC1/24/201411/21/2016 9/22/2014; 1/16/2015Yes (9/22/2014and 1/16/2015) Warning Letter - 11/2/20157 Yes
US Compounding, Inc., Conway, AR12/20/201312/31/20157/15/2016YesResumed operations after cessation of sterile operations and recall of sterile products7Yes
US Specialty Formulations LLC, Bethlehem, PA
1/31/201410/27/20165/29/2015YesWarning Letter - 9/30/2016Yes
- December 27, 2016 No comments:
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