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(Learning about USP Chapter <800> in 10 minutes a week.)
10. RECEIVING
Receiving facility and engineering controls are discussed in 5.1:
- SOPs must be prepared and implemented for receiving HDs.
- HDs should be received in impervious plastic from suppliers for segregation from non-HD drugs.
- HDs must be delivered to the designated HD storage area immediately after unpacking.
- PPE (including chemo gloves) must be worn during unpacking.
- A spill kit must be available in the receiving area.
- Table 4 presents a "Summary of Requirements for Receiving and Handling Damaged HD Shipping Containers." (These need to be incorporated into SOPs.)
- If opening damaged containers, transfer them to a nonsterile C-PEC if available. If only a sterile C-PEC is available, it can be used, but must be disinfected after decontamination, deactivation, and cleaning before resuming sterile compounding.
- Report damage to the Designated Person.
- Segregate HDs pending return in a designated negative pressure area and clean the area according to SOPs.
11. LABELING, PACKAGING, TRANSPORT AND DISPOSAL
SOPs must be prepared and implemented for labeling, packaging, transporting, and disposal of HDs. SOPs must address:
- Prevention of accidental exposures or spills
- Personnel training on response to exposure
- Use of a spill kit
11.1 Labeling
- HDs must be clearly labeled at all times.
11.2 Packaging
- Appropriate packaging to maintain physical integrity, stability, and sterility (if required) is to be used to protect the HD from damage, leakage, contamination, and degradation, and protection of personnel.
11.3 Transport
- Applicable federal, state, and local regulations must be followed when transporting HDs regarding labeling, storage, and handling.
- Do not transport liquid HDs or antineoplastic HDs in pneumatic tubes.
- If transporting outside the facility, consult the SDS Transport information and label appropriately.
11.4 Disposal
- Proper training is required of all personnel performing custodial waste removal and cleaning activities in HD handling areas.
- Disposal of all HD waste must comply with all applicable federal, state, and local regulations.
NOTE: New SOPs have been added this week on www.CompoundingToday.com.
QUESTIONS
- Who is going to enforce and require a supplier of HDs to package the HDs in impervious plastic?
- Regarding Table 4, if the unopened shipping package is damaged and is large, will large garbage bags suffice to enclose the shipping package? If so, should more than one be used?
- Can the segregated HD return waiting area be the same as the regular HD Storage Area or must it be separate?
- How can one find "impervious" packaging that is suitable for all situations? OR, does the formulation dictate the packaging due to various solvents, etc. Does impervious always mean "firm or hard" packaging or can it also mean "soft" packaging?
- "10 Receiving" mentions a "tiered approach" but only gives the starting tier...what are the other "tiers"?
- How "inclusive" and "extensive" is the labeling that is required for a HD at each point in the compounding, dispensing, and administration process?
- Regarding packaging, what criteria and data is available to evaluate the requirements in "11.2"?
- Regarding 11.3 Transport, does this also cover robotic dispensing equipment used in hospitals, etc.? Must the HDs be transported manually?
- Regarding 11.4 Disposal, are custodial personnel involved in waste removal and cleaning required to don all the required "PPE", etc.?
Note: The following question was not published in previous issues of this newsletter. We include it here to keep our readers informed.
- Can the cabinets used in the <800> rooms be the basic laminate cabinets used in most compounding labs?
For a full list of questions for which we are awaiting answers from USP, please go to: http://www.ijpc.com/USP800Questions
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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