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OSHA Hazard Communication Programs Update For Compounders

Compounders who have read USP〈800〉carefully are aware that there is a mandate for a “Hazard Communication Program,” but few of them actually may understand the business risks of failing to create one. This post hopefully will help to clarify certain important and pertinent aspects of a Hazard Communications Program. The Meaning and Definition of a Hazard Communications Program Whereas USP〈800〉has literally no compliance impact unless enforced by a poorly-informed state pharmacy board...
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What is a 503b Pharmacy (Outsourcing Facility)?

Medication production for patient use has always traditionally come from one of two sources: large scale pharmaceutical manufacturers, typically producing tens of thousands of doses daily under the jurisdiction of the Food and Drug Administration (FDA) and distributed via traditional retail or mail order pharmacies, and compounding pharmacies, extemporaneously preparing doses based on individual patient needs under the jurisdiction of their home state’s Board of Pharmacy. The growth in the...
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FDA Warning Letters – Significance and Implications

The scope of the regulatory responsibilities of the U.S. Food and Drug Administration is vast. Their mission is to protect the public health and they employ 16,914 civilians and 1,148 military, totaling 18,062. They are extremely “siloed” and slow to gain consensus on policy among their various internal groups. Their enforcement on the drug manufacturing sector stems from CFR 210 & 211, et seq., which constitutes “Current Good Manufacturing Practices,” abbreviated cGMP. The verbiage...
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Can the FDA Inspect a 503a Compounding Pharmacy & Facility?

The vast majority of compounding pharmacies in the US are state licensed facilities classified under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). A 503a pharmacy is allowed to compound drugs which are not FDA-approved, are not subject to the requirement that labeling bear adequate directions for use, and are not subject to CGMP requirements, and are provided to a patient only based on individual patient need (a valid prescription). These pharmacies are primarily under...
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