Sterile Compounding: New Laws and Regulations: A Review

I recently attended a symposium conducted by Western University of Health Sciences, College of Pharmacy entitled, Sterile Compounding New Laws And Regulations. This took place at the Newport Beach Hyatt on January 18 of this year, and it was truly rewarding. There were great speakers who had up-to-date information on the new laws – both state and federal – affecting sterile compounding.  David Miller, RPh, Executive Vice President of International Academy of Compounding Pharmacists, gave a great review of the Federal legislation (HR 3204) affecting sterile compounding pharmacies. He was able to define the various sections of 503A and 503B and how they impact current compounding pharmacy business models. Another great speaker was Amy Gutierrez, Chief Pharmacy Officer, for the Los Angeles County Department of Health Services.  She reviewed NECC accident as well as other issues affecting patient health relating to compounding pharmacies. This event took place on a Saturday, but was well worth the time and the information gained through an update of how pharmacy laws are affecting our practice to ensure that the needs of the patients of our clients are met. To view the class overview, objectives, and speakers’ bios, please click here.

- Quoted from here http://hartleymedical.com/blog/sterile-compounding-new-laws-and-regulations-a-review/#sthash.E2VG0rGL.dpuf

Guidance, Compliance & Enforcement Federal Register Notices

Guidance, Compliance & Enforcement Federal Register Notices

30 States Have Adopted Uniform Medication and Drug Testing Rules

Recent Horse Health and Welfare News | The Horse | TheHorse.com

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8 hours ago - Mid-Atlantic States Move Forward With Racehorse Drug Reform. January 31, 2014 ... 30 for an update on adoption of uniform medication and drug testing rules.

Ohio Board of Pharmacy Notice of Hearing Against The Metabolic Weight Loss Clinic did, on or before January 7, 2013 through May 22, 2013, purchase and possess an illegally compounded drug from Civic Center Pharmacy, NW Pharmacy & Compounding, and Complete Pharmacy & Medical Solutions and administered the same to patients, those drugs being: HCG 10,000 iu vials with diluent

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Janet Woodcock's Quality Agenda At CDER

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By Wayne Koberstein, executive editor
New mandates, new user fees, and new uncertainties occupy the FDA’s drug center in 2014.
Speaking in whole sentences may become an everrarer practice in this, the Abbreviated Age of texts and tweets — but Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research (CDER), is someone who speaks in whole paragraphs. She is not reading from a script; she spontaneously composes succinct, lucid, and informative statements based on logic and knowledge, requiring none of the editing we usually expect with extemporaneous speech. Woodcock speaks with the perspective of a builder, not an observer. Over many years, she has helped shape and construct the agency as it is today. Consequently, she has become the most consistent, reliable voice of the FDA for most people in the life sciences industry.

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New York Times Has Index Articles About Robert Courtney and his trial regarding diluted cancer drugs

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Question of the Day February 2, 2014 Why do all state boards of veterinary medicine not issue clarifying guidance regarding the use of compounding preparations just as the New Mexico Board of Veteinary Medicine has done?

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Iowa Board of Pharmacy Agenda for February 5, 2014 Meeting

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NABP Verified Pharmacy Program (VPP)

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NABP's Verified Pharmacy Program (VPP) streamlines the process for pharmacies obtaining or renewing licensure in multiple states. VPP assists applicants with meeting inspection requirements and allows for the distribution of necessary information to the boards where a new or renewed license is being sought.

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Home infusion and compounding guidelines published

 

Posted by: IVTEAM on Feb 1, 2014

#IVTEAM #Intravenous news: Two policies have been added to the Ivpolicy.com website. The first is the ASHP (2014) guidelines on home infusion pharmacy services preparations “The purposes of these guidelines are to define the role of the pharmacist in providing home infusion care to patients and to outline minimum requirements (indicated by use of the word “shall”) and best practices for the operation and management of services provided by pharmacies in the home or alternate-site setting. In broad terms, home infusion includes the provision of specialized, complex pharmaceutical products; development and execution of plans to manage the medication therapy of patients; and clinical assessment and monitoring of patients in their homes.” The second policy is the ASHP (2014) guidelines on compounding sterile preparations “These guidelines are intended to help compounding personnel prepare CSPs of high quality and reduce the potential for harm to patients and consequences for compound- ing personnel. The recommendations in these guidelines are based on published data, when available; on expert opinion and procedures used in similar industries; and on applicable regulations and standards.”
Reference:
ASHP (2014) Guidelines on home infusion pharmacy services preparations.
ASHP (2014) Guidelines on compounding sterile preparations.

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