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NHIA
18 hours ago - Re: Draft Guidance “Current Good Manufacturing Practice — Interim Guidance for. Human Drug Compounding Outsourcing Facilities Under Section 503B 0f the
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
Wednesday, September 3, 2014
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, WI, 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. Central Time 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]
quoted from here
Tainted-Injections Claims Survive Motions to Dismiss
Claims against New Jersey and Tennessee clinics that administered tainted epidural steroid injections linked to dozens of deaths have survived a dismissal motion in Boston federal court.
The contaminated drugs from the now defunct New England 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 New England 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
Rockville, MD 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,
The Pew Charitable Trusts 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 United States Pharmacopeia Chapter 797, the standard used by compounding pharmacies. The study, Quality Standards for Large-Scale Sterile Compounding Facilities, authored by Clinical 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
Rockville, MD 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,
The Pew Charitable Trusts 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 United States Pharmacopeia Chapter 797, the standard used by compounding pharmacies. The study, Quality Standards for Large-Scale Sterile Compounding Facilities, authored by Clinical 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
View shared postThe Tennessean
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.
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