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| U.S. Food and Drug Administration Compounding Compliance Policy Guidelines, Part 3 |
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This week, we will look at the Guidances (Drugs) related to compounding. We will begin by looking at the following current listing of Compounding Guidances. This list is currently available at:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm452240.htm
Starting next week, we will begin discussing the Guidances.
| Category | | Title | | Type | | Date |
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Compounding/
User Fees | | Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act
(PDF - 119KB) | | Final Guidance | | 08/03/15 |
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Compounding/
Procedural | | Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
(PDF - 74KB) | | Final Guidance | | 08/11/15 |
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Compounding/
Pharmaceutical Quality/
Manufacturing Standards (CGMP) | | Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
(PDF - 127KB) | | Draft Guidance | | 02/13/15 |
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Compounding/
Pharmaceutical Quality/
Manufacturing Standards (CGMP) | | Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
(PDF - 227KB) | | Draft Guidance | | 02/13/15 |
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Compounding/
Drug Safety | | Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
(PDF - 138KB) | | Final Guidance | | 10/07/15 | |
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Compounding/
Procedural | | Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
(PDF - 71KB) | | Final Guidance | | 11/21/14 |
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Compounding/
Procedural | | Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act"
(PDF - 70KB) | | Draft Guidance | | 11/21/14 | |
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Compounding/
Pharmaceutical Quality/
Manufacturing Standards (CGMP) | | Current Good Manufacturing Practice - Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
(PDF - 223KB) | | Draft Guidance | | 07/01/14 |
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Compounding/
Procedural | | Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance
(PDF - 85KB) | | Final Guidance | | 06/09/16 |
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Compounding/
Procedural | | Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
(PDF - 127KB) | | Final Guidance | | 06/09/16 |
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Compounding/
Procedural | | Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
(PDF - 227KB) | | Final Guidance | | 06/09/16 |
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| Compounding | | Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
(PDF - 296KB) | | Draft Guidance | | 04/15/16 |
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| Compounding | | Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act Guidance for Industry
(PDF - 81KB) | | Draft Guidance | | 04/15/16 |
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| Compounding | | Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act
(PDF - 244KB) | | Draft Guidance | | 04/15/16 |
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| Compounding | | Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
(PDF - 348KB) | | Draft Guidance | | 07/07/16 |
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| Compounding | | Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
(PDF - 108KB) | | Draft Guidance | | 07/07/16 |
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| Compounding | | Insanitary Conditions at Compounding Facilities Guidance for Industry
(PDF - 95KB) | | Draft Guidance | | 08/03/16 |
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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News
Specialty Pharmacy Grows by 13,381%
The problems Valeant Pharmaceuticals had with Philidor focused a harsh spotlight on specialty pharmacies, until then a little-noticed piece of the pharma supply chain. However, it is an area that is seeing tremendous growth by piggybacking onto manufacturer's success with specialty drugs. Note that a dozen specialty pharmacies made it to this year's Inc. magazine list of fastest growing private companies in the U.S., including one in the top 10.
http://www.fiercepharma.com/pharma/specialty-pharmacy-sees-13-381-growth-as-little-noticed-piece-market-soars
Taiwan Active Pharmaceutical Ingredient Plant Cited for Filthy, Smelly Rooms and Uncleaned Equipment
The FDA issued a warning letter to a Taiwanese active pharmaceutical ingredient (API) company, Taoyuan City-based Cheng Fong Chemical, after an inspection where investigators found a foul-smelling, filthy plant with insects and layers of unidentified material on the floors of rooms that had never been cleaned. The investigators found equipment that was corroded, dirty, pitted on the product surface of the equipment and leaking on and around the equipment. They also found cold rooms storing raw materials and intermediates used to make APIs that had foul odors and which officials acknowledged "had never been cleaned."
http://www.fiercepharma.com/manufacturing/fda-cites-taiwan-api-plant-for-its-filthy-smelly-rooms-uncleaned-equipment
Retraction of Eteplirsen Study Requested
Just one day after the FDA approved eteplirsen (Exondys 51, Sarepta) for the treatment of a subpopulation of boys with Duchenne muscular dystrophy and a specific genetic mutation, FDA Commissioner Robert Califf, MD, issued a memorandum calling for one study supporting the drug, published in Annals of Neurology in 2013, to be retracted. He wrote, "The publication [Ann Neurol 2013; 74: 637-647], now known to be misleading, should probably be retracted by its authors." He also stated, "In view of the scientific deficiencies identified in this analysis, I believe it would be appropriate to initiate a dialogue that would lead to a formal correction or retraction (as appropriate) of the published report."
The concerns were related to research facilities at Nationwide Children's Hospital in Columbus, Ohio, which conducted trials of eteplirsen where it was noted that "the procedures and controls that one would expect to see in support of a Phase 3 registrational trial were not in evidence."
http://www.pharmacypracticenews.com/Clinical/Article/09-16/FDA-Commissioner-Calls-for-Retraction-of-Eteplirsen-Study-/37976
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Did You Know ...
�that during the political events of the week, some of the media are actually now identifying themselves as the "Opinion Media"? This is in contrast to what we have known in the past where they presented themselves as "Fact Media," but they were giving their personal opinions and not facts.
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Tip of the Week
It is important to become aware of the news media and differentiate between the "opinion" and the "fact" media and do some "fact-checking"!
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Looking Back
To shaving brush,
I need not cling,
I will not hush,
Of thee I sing.
Burma Shave
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