| Drugs | MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX | Lot number 11142013@74 | Class I | Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis | Abrams Royal Pharamacy |
| Drugs | All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX | All unexpired lots of sterile drug products | Class II | Lack of Assurance of Sterility | Abrams Royal Pharamacy |
| Drugs | VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451. | Batch Number: 412-3732AA; expiration date 07/2016 (NDC# 65757-302-02; Kit Pacaging Lot Number: 2013-021; expiration date 07/2016 (NDC# 65757-300-01. | Class II | Customer complaints for failure to deliver the dose. | Alkermes, Inc. |
| Drugs | Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68. | Lot #: E21294K3C Exp Date: 6/29/2014 | Class I | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals |
| Drugs | Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48. | A) Lot #: E21294DK1C; Exp Date: 05/22/2014 B) Lot #: E21294DK3C; Exp Date: 06/08/2014 | Class I | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals |
| Drugs | Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70. | Lot #: E131210.212 Exp: 07/14/2014 | Class II | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals |
| Drugs | Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78. | Lot #: E0333282R; Exp: 7/13/2014 | Class I | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals |
| Drugs | PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 | Lot # 13-920741-0-1 EXP 21 JUN 2014 | Class I | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. |
| Drugs | del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 | Lot# 13-920742-0-1 EXP 21 JUN 2014 and Lot# 13-920452-0-1 through 13-920452-0-30, EXP 21 JUN 2014 | Class I | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. |
| Drugs | adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 | Lot# 13-920757-0-1 through Lot# 13-920757-0-5 (5 total doses) EXP 06 JUL 2014 | Class I | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. |
| Drugs | LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 | Lot # 13-920739-01 through Lot # 13-920739-04 (4 total doses) EXP 21 Jun 2014 | Class I | Non Sterility; microbial contamination identified as Aspergillus
species |
Central Admixture Pharmacy Services, Inc. |
Thursday, September 4, 2014
Look at the Compounded Medications on the FDA September 2, 2014 Enforcement Report; Source found here http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=09032014&lang=eng#drugs
Oklahoma set to release findings on execution in which
Oklahoma set to release findings on execution in which ...
Important Comment Regarding Earlier Post of OptumRx Presentation
This is a very important presentation; in and of itself, an important quantitative public health safety signal.
It was very challenging to obtain guarantees that bulk chemical ingredients (active and inactive) were not adulterated and had the specifications required for the dosage forms I was asked to make, including spinal and respiratory drugs, now over 20 years ago--I am not sure if this has improved as many chemicals for compounding are advertised in a "use at your own risk" or "for research and development" manner. Insurers may not be aware of the status of product liability coverage for drugs made from chemical powders, on the basis of formulas that may also come with disclaimers on safety and effectiveness. Pharmacies and/or their business partners advertise and market the products, sometimes making claims the products are safe and effective based on preliminary, un-scruitinized studies (demand generation). But because pharmacists are not learned intermediaries, liability associated with marketing and sale of non-FDA approved products can sometimes be extended to other parties in the drug access chain--this may also implicate payers that cover the drugs in their formularies, if pharmacies do not obtain product liability insurance for the products they market and promote?
The multifaceted interventions developed by OptumRx will help protect the drug supply without compromising access to compounded drugs, where necessary.
It was very challenging to obtain guarantees that bulk chemical ingredients (active and inactive) were not adulterated and had the specifications required for the dosage forms I was asked to make, including spinal and respiratory drugs, now over 20 years ago--I am not sure if this has improved as many chemicals for compounding are advertised in a "use at your own risk" or "for research and development" manner. Insurers may not be aware of the status of product liability coverage for drugs made from chemical powders, on the basis of formulas that may also come with disclaimers on safety and effectiveness. Pharmacies and/or their business partners advertise and market the products, sometimes making claims the products are safe and effective based on preliminary, un-scruitinized studies (demand generation). But because pharmacists are not learned intermediaries, liability associated with marketing and sale of non-FDA approved products can sometimes be extended to other parties in the drug access chain--this may also implicate payers that cover the drugs in their formularies, if pharmacies do not obtain product liability insurance for the products they market and promote?
The multifaceted interventions developed by OptumRx will help protect the drug supply without compromising access to compounded drugs, where necessary.
Missouri misled on execution drugs used: media report
Missouri misled on execution drugs used: media report ...
news.yahoo.com/missouri-misled-execution-drugs-used-me...
1 day ago - Many states have turned to compounding pharmacies to procure the drugs, and Missouri has been particularly secretive about its protocols, refusing to say ...Department of Justice Press Release Regarding Compounding Pharmacist Glenn Adam Chin
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Thursday, September 4, 2014
Supervising Pharmacist Arrested at
A , man was arrested today at Boston's Logan International Airport in connection with the ongoing criminal investigation of (NECC) by the Justice Department’s Civil Division and U.S. Attorney’s Office for the District of Massachusetts.
Glenn Adam Chin, 46, was attempting to board a plane to Hong Kong when he was arrested by federal authorities on one count of mail fraud. He is scheduled to appear before Chief Magistrate Judge Jennifer C. Boal in the U.S. District Court for the District of Massachusetts later today. The maximum sentence under the statute is 20 years in prison, followed by three years of supervised release and a $250,000 fine.
The U.S. Attorney’s Office and the Civil Division’s Consumer Protection Branch have conducted an active ongoing criminal investigation of NECC since the nationwide fungal meningitis outbreak began in the fall of 2012. Following the outbreak, the () reported that 751 patients across the country were diagnosed with a fungal infection after receiving injections of preservative-free methylprednisolone acetate, or MPA, compounded at NECC. The reported that of those 751 patients, 64 died.
Chin was a supervising pharmacist at NECC who was involved in compounding the contaminated MPA that caused the outbreak. The criminal complaint charges Chin with participating in a scheme to fraudulently cause one lot of MPA to be labeled as injectable, meaning that it was sterile and fit for human use, and shipped to one of NECC’s customers, Michigan Pain Specialists. As alleged in the affidavit, after receiving the MPA from NECC, doctors at Michigan Pain Specialists injected the drug into their patients believing it to be injectable as labeled. As a result, 217 of those patients contracted fungal meningitis, and 15 of those patients died.
Although the criminal investigation of Chin and others is ongoing, the U.S. Attorney's Office charged and arrested Chin today after federal authorities learned that he was planning to leave the country on an international flight that was scheduled to depart this morning.
If you are a victim in the NECC matter you may call the U.S. Attorney's Office victim assistance message line at 888-221-6023 or email usama.victimassistance@usdoj.gov to obtain case status information or assistance. You may also find information at: http://www.justice.gov/usao/ma/news.html .
U.S. Attorney Carmen M. Ortiz; Assistant Attorney General Stuart F. Delery for the Civil Division; Acting Special Agent in Charge James Royal of the , ; Special Agent in Charge Vincent Lisi of the FBI’s Boston Field Division; Inspector in Charge Kevin Niland of the U.S. Postal Inspection Service; Special Agent in Charge Jeffrey Hughes of the U.S. Department of Veterans Affairs, Office of Inspector General Northeast Field Office and Resident Agent in Charge Patrick J. of the Defense Criminal Investigative Service-Office of Inspector General , made the announcement today. The case is being prosecuted by George P. Varghese and Amanda P.M. of U.S. Attorney Ortiz’s Health Care Fraud Unit, and John W.M. Claud of the Civil Division’s Consumer Protection Branch.
The details contained in the complaint are allegations. The defendant is presumed innocent unless and until proven guilty beyond a reasonable doubt in a court of law.
Ex-New England Compounding Pharmacist Arrested in Boston
A former pharmacist at New England Compounding Center, the now-bankrupt company tied to a 2012 meningitis outbreak that killed 64 people, was arrested as he attempted to board a flight from to Hong Kong.
Glenn Chin, 46, was detained at and charged with one count of mail fraud, the U.S. Attorney’s Office said in a statement. Chin is scheduled to appear in federal court later today, it said.
The pharmacy’s tainted drugs, including a steroid administered by spinal injection, caused 64 deaths and 751 cases of meningitis, according to the Centers for Disease Control and Prevention, and led to calls by Congress for greater federal oversight of such companies.
quoted from here
Glenn Chin, 46, was detained at and charged with one count of mail fraud, the U.S. Attorney’s Office said in a statement. Chin is scheduled to appear in federal court later today, it said.
The pharmacy’s tainted drugs, including a steroid administered by spinal injection, caused 64 deaths and 751 cases of meningitis, according to the Centers for Disease Control and Prevention, and led to calls by Congress for greater federal oversight of such companies.
quoted from here
Must watch Webinar: Limiting the Impact of Compounding Pharmacies by United Healthcare and OptumRx
Compounded medicines are increasingly being dispensed for common disorders such as pain management, women’s health, men’s health, and weight loss and are also being prepared as vitamins, supplements and cosmetic treatments.1 The use of compounded medicines raises concerns about quality, cost and patient safety — and the practice is on the rise. Between 2012 and 2013, our customers have seen a 35 percent increase in spend for compounded prescriptions and it is now often a Top 5 trend driver for many clients.2 According to a compounding industry source, some 2,500 U.S. pharmacies added compounding practices between 2009 and 2012, bringing the total number of compounding pharmacies to over 7,500.3
OptumRx recently hosted a webinar for brokers and consultants; Compounding Pharmacies: A Costly Challenge. discussion on the impact of compounding pharmacies and strategies implemented to limit the impact.
UnitedHealthcare and OptumRx both employ strategies to manage compounds - focusing on eliminating concerns of member safety, drug efficacy and potential waste of healthcare resources.
Business Week. America's Shadow Pharmacies. November 14, 2012.
OptumRx recently hosted a webinar for brokers and consultants; Compounding Pharmacies: A Costly Challenge. discussion on the impact of compounding pharmacies and strategies implemented to limit the impact.
UnitedHealthcare and OptumRx both employ strategies to manage compounds - focusing on eliminating concerns of member safety, drug efficacy and potential waste of healthcare resources.
- Identifying bulk chemicals for benefit exclusion as they hit the market
- Requiring a notification/prior authorization for compound medications, that are reviewed and approved by our National Pharmacy &Therapeutic Committee
- Extensive list of non-FDA approved bulk chemicals used in compounds maintained regularly to ensure products are not approved
- Network pharmacies are monitored by the OptumRx Pharmacy Network team to ensure pharmacies abide by state federal law, must be credentialed, accredited and licensed to practice – in addition, OptumRx has a network audit team tracks and investigates high-dollar compounds
- Targeted outreach to high prescribers of compounds through peer-to-peer and written communications
Business Week. America's Shadow Pharmacies. November 14, 2012.
- UnitedHealthcare carve-in book of business, twelve-month period between 2012 and 2013.
- International Academy of Compounding Pharmacies.
Alberta College of Pharmacy Seeking Comments on Draft Model Standards for Pharmacy Compounding of Hazardous Sterile Products
is circulating national draft Model Standards for Pharmacy Compounding of Hazardous Sterile Products for review and comment, in conjunction with NAPRA's national consultation. Comments are due to by November 5.
Note that these standards are quite similar in many areas to the draft Model Standards for Pharmacy Compounding of Non-hazardous Sterile Products which are also being circulated for review and comment. To facilitate easier review, standards specifically dealing with hazardous product compounding have been highlighted in yellow.
Please see the consultation invitation letter for details on how to participate. Submit all comments using the comment template.
Note that these standards are quite similar in many areas to the draft Model Standards for Pharmacy Compounding of Non-hazardous Sterile Products which are also being circulated for review and comment. To facilitate easier review, standards specifically dealing with hazardous product compounding have been highlighted in yellow.
Please see the consultation invitation letter for details on how to participate. Submit all comments using the comment template.
Healthcare spending growth expected to hit 5.6% this year
Health expenditures grew 3.6% last year, but spending fueled by an improving economy and the healthcare reform law's insurance and Medicaid expansions are likely to turn that around. (MODERN HEALTHCARE)
FULL STORY »
FULL STORY »
Wednesday, September 3, 2014
17 comments made to Draft Guidance for Industry on Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act; Availability
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Attached please find comments to the Draft Guidance for Industry on Current Good Manufacturing Practice - Interim Guidance for Human Drug Compounding Outsourcing Facilities
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Public Submission
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Posted:09/03/2014
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ID:FDA-2014-D-0779-0018
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Agency:FDA
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RIN:Not Assigned
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Docket ID:
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Organization:
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Submitter Name:
Comment Period Closed
Sep 02, 2014 11:59 PM ET
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See attached file(s)
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Public Submission
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Posted:09/03/2014
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ID:FDA-2014-D-0779-0004
Drug Spending Expected To Rise 6.8% In 2014 With ACA Coverage Expansion
Drug Spending Expected To Rise 6.8% In 2014 With ACA Coverage Expansion / Prescription drug spending across private and government insurance markets will top $290 billion in 2014, driven by the availability of broader coverage, the latest CMS National Health Expenditures report projects. / “The Pink Sheet” DAILY September 3 2014 5:35 PM
IACP Submits Comments on FDA's Draft Guidance for Industry on Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act
IACP filed yesterday the second of two formal comments to FDA - FDA's Interim Guidance for Human Drug Compounding Outsourcing Facilities 503B.
IACP also filed comments on September 2nd regarding the FDA's "do not compound" list focusing primarily on the agency's circumvention of the Pharmacy Compounding Advisory Committee and a lack of procedures for adding or modifying the list in the future - 503A.
New Zealand: Blood doping vial found in stable – three banned
Heavy bans have been handed down to the three men involved in racing's first case of , the judicial committee sending a clear message that the blood doping substance has no place in the industry.
owner Calvin Fisher, the person the Judicial Control Authority committee blamed as being primarily responsible for the vial of reaching the stable of Ashburton trainer Len Faber, was disqualified for 20 months for an act detrimental to the interests of racing.
He was also ordered to pay a total of $9000 in costs to the Racing Integrity Unit and JCA.
continue to read here
owner Calvin Fisher, the person the Judicial Control Authority committee blamed as being primarily responsible for the vial of reaching the stable of Ashburton trainer Len Faber, was disqualified for 20 months for an act detrimental to the interests of racing.
He was also ordered to pay a total of $9000 in costs to the Racing Integrity Unit and JCA.
continue to read here
NHIA Draft Guidance “Current Good Manufacturing Practice — Interim Guidance for. Human Drug Compounding Outsourcing Facilities Under Section 503B
[PDF]
NHIA
18 hours ago - Re: Draft Guidance “Current Good Manufacturing Practice — Interim Guidance for. Human Drug Compounding Outsourcing Facilities Under Section 503B 0f the
NHIA
Breaking News!!! Recall!! Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall - Lack of Assurance of Sterility
[Posted 09/02/2014]
AUDIENCE: Pharmacy, Patient
ISSUE: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. If the sterility of a compounded preparation is compromised, a patient is at risk for infection.
BACKGROUND: Martin Avenue Pharmacy, Inc. supplied compounded sterile preparations to the offices of licensed medical professionals and individual patients by prescription until 08/20/14 in multiple states including IL, , OH, MI, FL, AL, and TX.
RECOMMENDATION: Patients and healthcare providers that have product which is being recalled should stop using the products, and follow the instructions in the recall notice. Martin Avenue Pharmacy, Inc. is notifying its customers of this recall by fax, mail, phone or email with instruction on how to return recalled compounded sterile preparations to the pharmacy.
Consumers or health care providers with questions regarding this recall may contact Martin Avenue Pharmacy, Inc. by phone at (630) 355-6400 or toll free (888) 355-6492, Monday through Friday, 9:00 a.m. to 7:00 p.m. or by e-mail at info@martinavenue.com.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/27/2014 - List of Recalled Products - Martin Avenue Pharmacy, Inc]
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Tainted-Injections Claims Survive Motions to Dismiss
Claims against and Tennessee clinics that administered tainted epidural steroid injections linked to dozens of deaths have survived a dismissal motion federal court.
The contaminated drugs from the now defunct Compounding Center have been linked to outbreaks of fungal meningitis and other infections that started in 2012 and have been blamed for 751 injuries and 64 deaths.
Read more: http://www.nationallawjournal.com/id=1202668709695/TaintedInjections-Claims-Survive-Motions-to-Dismiss#ixzz3CG8C3JcC
The contaminated drugs from the now defunct Compounding Center have been linked to outbreaks of fungal meningitis and other infections that started in 2012 and have been blamed for 751 injuries and 64 deaths.
Read more: http://www.nationallawjournal.com/id=1202668709695/TaintedInjections-Claims-Survive-Motions-to-Dismiss#ixzz3CG8C3JcC
Canadian Society of Hospital Pharmacists. Official Publication Compounding: Guidelines for Pharmacies 2014
Home > Products and Publications
NEW Official Publication
Compounding: Guidelines for Pharmacies 2014 - Now available!
This comprehensive set of guidelines covers the compounding in pharmacies whenever compounded preparations are intended for human use, regardless of the route of administration or whether the preparation is related to research purposes. These guidelines also apply to the preparation of radiopharmaceuticals and other hazardous pharmaceuticals.
Available in English (French translation in progress)
| Compounding: Guidelines for Pharmacies 2014 (Electronic Copy) | Price |
|---|---|
| CSHP member & supporter price | $375.00 |
| Full Price | $750.00 |
PEW Foundation Comments to FDA on 503B Quality Standards Draft Guidance
On September 2, Pew submitted comments to the U.S. Food and Drug Administration in response to draft guidance on the implementation of Title I of the Drug Quality and Security Act.
The comments highlight the need for more robust safeguards when compounding occurs on a larger scale and reference the Pew commissioned report “Ensuring the Safety of Compounded Drugs: Study highlights key quality standards.”
Download the PDF
September 2, 2014
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
20852
Re: FDA Draft Guidance: Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act.
Dear Sir or Madam,
is an independent, nonpartisan research and policy organization dedicated to serving the public. Pew has a longstanding focus drug quality, including pharmaceutical compounding. We supported federal legislation to improve compounding oversight in 2013, and have conducted research and convened stakeholder summits.
In 2014 we commissioned a study that compares Current Good Manufacturing Practices (CGMPs), the standard applied to pharmaceutical companies, with Chapter 797, the standard used by compounding pharmacies. The study, Quality Standards for Large-Scale Sterile Compounding Facilities, authored by IQ LLC, highlights the more robust safeguards needed when compounding occurs on a larger scale.
We appreciate the opportunity to comment on FDA draft guidance on CGMPs for outsourcing facilities, which will be permitted to compound not pursuant to a patient prescription. Such facilities will register and submit to FDA oversight, maintain strict quality standards, and adhere to certain other requirements. This draft guidance provides a roadmap that will help outsourcing facilities understand how the agency intends for them to comply with CGMPs, and what standards are of particular importance to sterile compounding activities. This clarity is important for facilities that elect to join the new 503B regulatory category, which is voluntary, and will help support successful implementation.
continue to read here
The comments highlight the need for more robust safeguards when compounding occurs on a larger scale and reference the Pew commissioned report “Ensuring the Safety of Compounded Drugs: Study highlights key quality standards.”
Download the PDF
September 2, 2014
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
20852
Re: FDA Draft Guidance: Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act.
Dear Sir or Madam,
is an independent, nonpartisan research and policy organization dedicated to serving the public. Pew has a longstanding focus drug quality, including pharmaceutical compounding. We supported federal legislation to improve compounding oversight in 2013, and have conducted research and convened stakeholder summits.
In 2014 we commissioned a study that compares Current Good Manufacturing Practices (CGMPs), the standard applied to pharmaceutical companies, with Chapter 797, the standard used by compounding pharmacies. The study, Quality Standards for Large-Scale Sterile Compounding Facilities, authored by IQ LLC, highlights the more robust safeguards needed when compounding occurs on a larger scale.
We appreciate the opportunity to comment on FDA draft guidance on CGMPs for outsourcing facilities, which will be permitted to compound not pursuant to a patient prescription. Such facilities will register and submit to FDA oversight, maintain strict quality standards, and adhere to certain other requirements. This draft guidance provides a roadmap that will help outsourcing facilities understand how the agency intends for them to comply with CGMPs, and what standards are of particular importance to sterile compounding activities. This clarity is important for facilities that elect to join the new 503B regulatory category, which is voluntary, and will help support successful implementation.
continue to read here
Ohio Pharmacists Association Compounding Meeting
September 18, 2014
10:00AM
Compounding SIG Meeting
OPA Office- 2674 Federated Blvd, Columbus, OH 43235
Tuesday, September 2, 2014
Saint Thomas fails to get meningitis suit dismissed
Here is the Criminal Complaint Filed in N.J. Federal District Court Against A Compounding Pharmacist Paying Kickbacks for Compounded Pain Creams to a Physician
January 9, 2014
pharmacist charged with paying more than $50,000 in kickbacks to doctor for prescription referrals
A pharmacist with a compounding pharmacy in Lakewood, N.J., was arrested today and charged with paying more than $50,000 to a Toms River, N.J., physician to induce the doctor to make prescription referrals to the pharmacy.
Kleyman, Vladimir Complaint
The case is still pending.
pharmacist charged with paying more than $50,000 in kickbacks to doctor for prescription referrals
A pharmacist with a compounding pharmacy in Lakewood, N.J., was arrested today and charged with paying more than $50,000 to a Toms River, N.J., physician to induce the doctor to make prescription referrals to the pharmacy.
Kleyman, Vladimir Complaint
The case is still pending.
Bankruptcy Trustee Seeks to Limit Discovery of Pharmacy's Owners, Insurers
Paul D. Moore, the trustee in the New England Compounding Center's bankruptcy, wants to stay related multidistrict litigation (MDL) court actions against, and limit discovery into, the “insiders” who owned the pharmacy, the pharmacy's landlord and the ... (registration required)
Florida receives $300,000 in pharmacy settlement for kickbacks
TALLAHASSEE, . — Attorney General says the state is getting $300,000 as part of a national settlement with a Cincinnati-based company that allegedly engaged in a kickback scheme with skilled-nursing facilities.
continue to read here
continue to read here
Could Pennsylvania botch an execution? - The Morning Call
Could Pennsylvania botch an execution? - The Morning Call
www.mcall.com/.../mc-lehigh-lethal-injection-drugs-20...
Monday, September 1, 2014
Inventory Requirements When a Drug is Scheduled in Kansas
Inventory Requirements When a Drug Is
Scheduled
Tramadol became a federally controlled Schedule IV drug beginning
August 18, 2014. Pursuant to 21 CFR §1304.11, a pharmacy
is required to take an inventory of any CS that is added to the list
on the effective date of the rule. Thereafter, the substance needs
to be included in each inventory made by the registrant.
Kansas requires an annual inventory of CS. Each inventory of
Schedule II CS and all products containing hydrocodone require
an exact count. Make sure you designate on the inventory whether
it was taken at the beginning or close of business.
The Kansas State Board of Pharmacy has taken steps to have
tramadol removed from the Kansas Tracking and Reporting of
Controlled Substances (K-TRACS) drugs of concern regulation.
Tramadol will need to be reported to K-TRACS now that it has
been federally scheduled.
source found here
Multiple Prescriptions of a Schedule II CS in Kansas
Multiple Prescriptions of a Schedule II CS
The federal rule allows a practitioner to provide a patient with
multiple prescriptions on the same day for the same Schedule II
controlled substance (CS) to be filled sequentially. There is no
federal or state limit on the amount a prescriber can prescribe, but
when a prescriber issues multiple prescriptions of the same drug
on the same day, the combined amount shall not exceed a 90-day
supply. It is up to the prescriber to determine how many separate
prescriptions to write. For example, a prescriber may issue three
30-day Schedule II prescriptions to cover the 90 days, or he or she
may issue nine 10-day Schedule II prescriptions to cover the 90
days. Each prescription must be individually written on a separate
prescription. Once the prescription is filled, the inspector would
expect to find either three separate canceled prescriptions or nine
canceled prescriptions.
Source found here
APHA: Two years after meningitis outbreak, Massachusetts passes compounding overhaul
Pharmacists who compound preparations within the Commonwealth of Massachusetts and those who ship compounded preparations into the state from elsewhere must adhere to new regulations starting this December. Gov. of Massachusetts signed HB 4235, which effectively overhauls the regulation of pharmaceutical compounding in the state, on July 10. Sections of the law take effect in December. The entire law takes effect June 30, 2015.
continue to read here
continue to read here
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