(Learning about USP Chapter <800> in 10 minutes a week.)

5.4 Containment Supplemental Engineering Controls

• Containment supplemental engineering controls include:
  • Closed System Transfer Devices (CSTDs)
• CSTDs can provide an additional level of protection during compounding or administration.
• There is no published universal performance standard for evaluating CSTD containment.
• Evaluate CSTD performance based on:
  • Independent, peer-reviewed studies and
  • Demonstrated containment reduction.
• A CSTD must NOT be used as a substitute for a C-PEC for compounding.
• CSTDs should be used during compounding when compatible with the dosage form being compounded.
• CSTDs must be used when administering antineoplastic HDs, when feasible.
• CSTDs that are physically or chemically incompatible with a specific HD must not be used for that HD.

Note: Further information on CSTDs can be found at:

     IJPC 20(3): Mar/Apr 2016, 148-154.
     IJPC 16(5): Sep/Oct 2012, 431-433.

QUESTIONS
Answers will be posted in this Newsletter as they are received for one issue; then they are moved to the International Journal of Pharmaceutical Compounding's website and all questions and answers will be available at: www.ijpc.com/USP800Questions

Additional Questions:

32. Regarding both "nonsterile" and "sterile" HD compounding, can "Gowns" be re-worn during the same day if a compounder must leave the HD compounding area for some reason? If so, how should it be "removed, stored, and donned"?
33. Is there an "evaluation tool" one can use for evaluating CSTD's performance when looking at independent, peer-reviewed studies and demonstrated containment reduction? Is there a "standard" for comparison?
34. I assume that a CSTD would be physically incompatible for compounding use due to physical dimensions, shape, composition, etc., but how can a CSTD be "chemically incompatible"?

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

Pharmakon Pharmaceuticals Ceases Sterile Production
Pharmakon Pharmaceuticals in Noblesville has temporarily ceased manufacturing and recalled its sterile products after a federal investigation of its facilities. The company issued a voluntary recall in February for an intravenous form of morphine sulfate which was "superpotent"; it was sent to one medical facility in Indiana and one in Illinois, according to the FDA.
http://www.indystar.com/story/news/2016/04/20/fda-asks-noblesville-pharmacy-pause-manufacturing/83245732/

Did You Know ...

�that the FDA has issued three more "Guidances" on compounding related to the following?

• Prescription Requirements
• Hospital and Health System Compounding
• 503B Facility Definition

Tip of the Week

Obtain a copy of each of the "Guidances," review them, and let your pharmacy organizations know about any concerns you might have. They can be obtained at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM496286.pdf

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM496287.pdf

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM496288.pdf

Looking Back

Noah had whiskers,
In the ark,
But he wouldn't get by,
On a bench in the park!
     Burma Shave