In previous weeks, we have looked at the approach the FDA is using for 503A pharmacies. Now, we will look at their approach for the 503B Outsourcing Facilities.

Released in January 2018, this Guidance is arranged as follows:

1. INTRODUCTION AND SCOPE
   
   
2. BACKGROUND
   1. Section 503B of the FD&C Act
   2. Compounding, Generally
   3. Compounded Drugs that are Essentially Copies of Approved Drug Products
   4. Compounded Drugs that are Essentially Copies of Unapproved Non-Prescription Drug Products
      
      
3. POLICY
   1. Definition of Essentially a Copy of an Approved Drug
   2. Recordkeeping

APPENDICES A & B

Over the next couple of weeks, we will discuss the highlighted items above. A complete copy of the Guidance can be obtained at:

https://www.fda.gov/downloads/drugs/guidancecomplianceregulatory
information/guidances/ucm510153.pdf

Keep in mind that this approach is for 503B Outsourcing Facilities, NOT traditional 503A pharmacies. Currently, there are 69 Registered Outsourcing Facilities. For a complete, current list, go to:

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
PharmacyCompounding/ucm378645.htm

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

Did You Know ...

�that Will Rogers said?

"The only difference between death and taxes is that death doesn't get worse every time Congress meets."

Tip of the Week

Generally, most citizens don't mind paying reasonable taxes because we do benefit from their use (protection, infrastructure, etc.). However, what is very upsetting is the WASTE of our hard-earned tax dollars. Whatever happened to "zero-based budgets" and having to "justify how the money is spent" each year? There is far too much being thrown away on programs that are inflated, useless, stifle productivity, and, in many cases, are duplicative in nature. Makes one wonder, "Who's in Charge Here?"

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Looking Back

These signs are not,
For laughs alone,
The face they save,
May be your own!
     Burma Shave