Educational Materials - Regulatory Pack

Compounding Pharmacy Compliance conference held in June 2021 assembled expertise from regulatory agencies, 503A, 503B, community pharmacies and compounding solutions providers for a 3-day event that was loaded with continuing education and regulatory updates. Now we bring the best of those resources to our audience at IVT. 

You can purchase the Regulatory highlights from the presentations, assembled here for compounders or compounding facailities looking for tools and know-hows to stay compliant and informed. This kit inlcudes:

Videos

1. Current trends in Addressing Beyond-Use-Dates and Stability Testing
2. Expectations for the Future – an FDA Update
3. Impact of the Memorandum of Understanding on Compounding Pharmacies

Slide Decks

1. Keynote Address, Expectations for the Future
2. Impacts of COVID-19 Pandemic – Current Roles, Responsibilities and Regulation of Drug Compounders
3. Current Trends in Addressing Beyond-Use-Dates and Stability Testing

Toolkit

1. Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products
2. Contract Manufacturing Arrangements for Drugs: Quality Agreements
3. Current Good Manufacturing Practice for Phase 1 Investigational Drugs
4. FDA Temporary Policy for Outsourcing Facilities
5. PDA-FDA Joint Regulatory Conference 2017 - Change

For More information on the resources listed click here.