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

12. DISPENSING FINAL DOSAGE FORMS

• HDs with no further manipulation other than counting/repackaging, may be prepared for dispensing without any further requirements, UNLESS
  • required by the manufacturer, or
  • if visual evidence of exposure hazards are present (dust, leakage, etc.).
• Clean and dedicated equipment MUST be used with HDs.
• Antineoplastic tablet and capsules MUST NOT be placed in automated counting or packaging machines.

13. COMPOUNDING

• A plastic-backed preparation mat SHOULD be placed on the work surface of a C-PEC when compounding HD preparations.
• The mat SHOULD be changed immediately if a spill occurs and regularly during use.
• The mat SHOULD be discarded at the end of the daily compounding activity.
• Disposable or clean equipment (mortars, pestles, spatulas) MUST be dedicated for use with HDs.
• Protect personnel during particle-generating activities (including crushing tablets, opening capsules, weighing powders).

14. ADMINISTERING

• Appropriate PPE MUST be worn when administering HDs.
• After use, PPE MUST be removed and disposed of appropriately.
• Associated equipment/supplies for administration MUST be disposed of properly after administration.
• CSTDs MUST be used for administration of antineoplastic HDs when the dosage form allows.
• Healthcare personnel SHOULD avoid manipulating HDs (crushing, opening capsules, etc.) if possible.
• If manipulation is required, personnel MUST don appropriate PPE and use a plastic pouch to contain any dust or particles generated.

QUESTIONS

74. It seems like Section 12 Dispensing Final Dosage Forms refers only to "nonsterile" dosage forms. Are sterile dosage forms also included, as it seems that some may be handled here?
75. Regarding Section 14 Administering (paragraph 2), is it necessary for our nurses to don, doff, and discard PPE every time a room is entered for administration of a HD?

For a full list of questions for which we are awaiting answers from USP, please go to: http://www.ijpc.com/USP800Questions

NOTE: Additional SOPs related to hazardous drugs have been posted this week at www.CompoundingToday.com.

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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Did You Know ...

�that the FDA released a Guidance dated June 2016 regarding Bulk Drug Substances for 503A compounding pharmacies? The guidance stated that, in summary, until a substance has been evaluated and is identified in a final rule as being included or not included on the 503A bulks list, the FDA does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a bulk drug substance that appears on the Category 1 bulks list and is on the website at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/PharmacyCompounding/UCM467373.pdf.

Tip of the Week

A 503A Category I bulk drug substance is under evaluation and may be eligible for inclusion on the 503A bulks list; they have been nominated with sufficient supporting information for evaluation and do not appear on any other list. Until they are evaluated and a decision is made, they can be used in compounding.

A similar Guidance has been released for 503B pharmacies.

Looking Back

Tho stiff, the beard,
That nature gave,
It shaves like down,
With�
     Burma Shave