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, May 27, 2015
Will scrutiny press insurers into covering high-cost drugs?
Will scrutiny press insurers into covering high-cost drugs?
Healthcare Dive-3 hours agoThe subject of high-cost drug accessibility is in the spotlight following two recent ... Among the highest cost drivers were compounded therapies, hepatitis C and ...
Recalls since DQSA was passed as of March 2015
Recalls
• Nearly 20 firms have recalled compounded drugs in
the last year, many due to conditions and practices
resulting in a lack of drug sterility assurance
• Some recalls overseen by FDA, others overseen by the
state
• 2 letters formally asking firms to recall compounded
drugs after they refused informal requests
• Voluntary Cessation of Operations
• Over 10 firms have temporarily or permanently
ceased sterile operations in the last year
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Question of the Day May 27, 2015 Are state boards of pharmacy willing to shoulder the responsiblity and not blame the FDA if another incident similiar to NECC from office use (non registered outsourcing facility) compounding occurs if Senator Vitter's amendment passes? What, other than voluntary registeration for outsourcing facilities, will be any different than pre-NECC if the amendment passes? Will it be a huge relief of FDA time and resources and a shield from future blame if Senator Vitter's Amendment passes? Why or why not? Where is the highest risk of a possible NECC like outbreak to the public? Would Senator Vitter's amendment reduce, increase or have no impact on that risk?
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FDA Inter-governmental Working Meeting on Pharmacy Compounding held March 18-19, 2015 with meeting materials from FDA, and a number of boards of pharmacy
Meeting Presentations
Jane A. Axelrad – Compounding Policy Overview (PDF - 64KB)- Jane A. Axelrad – Draft Standard Memorandum of Understanding (MOU) (PDF - 49KB)
- Jane A. Axelrad – Bulk Drug Substance Lists (PDF - 35KB)
Mark D. Johnston and John Clay Kirtley – Memorandum of Understanding Under Section 503A (PDF - 201KB)Jane A. Axelrad – Outsourcing Facility Registration Issues (PDF - 31KB)Linda M. Bethman – Maryland: Response to DQSA – Outsourcing Facilities (PDF - 739KB)Cheri Atwood, R.Ph – Mississippi Board of Pharmacy (PDF - 17KB)Sarah Kotler and Lauren DiPaola – Sharing Non-Public Information (PDF - 393KB)Alonza Cruse – Update on Inspections of Sterile Drug Compounding Facilities (PDF - 1.5MB)Michael Levy, J.D. – FDA Regulatory Actions Involving Drug Compounding (PDF - 47KB)Gay Dodson, R.Ph – Sterile Compounding Enforcement (PDF - 156KB)Eric Nelson – Animal Drug Compounding (PDF - 182KB)Hal Wand - Arizona Veterinary or Is it Pharmacy (PDF - 3.8MB)Steve Hart, R.Ph – Veterinarian Compounding Issues in Kentucky (PDF - 445KB)
The FDA Answers Why Congress Was Concerned and Should be with Interstate Distribution Amounts of Compounded Drugs
Why is interstate distribution a
concern?
• State-licensed pharmacies primarily overseen by states
• Congress did not intend for compounders operating
under the exemptions in section 503A to grow into
conventional manufacturing operations making
unapproved drugs and operating a substantial portion of
their business interstate
• If a substantial proportion of a compounder’s drugs are
distributed outside of a State’s borders, adequate
regulation of those drugs can pose logistical, regulatory,
and financial challenges to State regulators; can be
difficult to investigate and address multi-state outbreaks
• If a poor performing pharmacy locates in a state with
inadequate controls, patients in other states are at risk
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