Packing and Transport USP 797

Sterile Non-Hazardous Compounding <797>

Packing and Transport
Sterile Non-Hazardous Compounding <797>

 

Purpose/ Applicability:  The purpose of this standard operating procedure (SOP) is to provide processes and procedures for the proper packaging, storage, and transport of CSPs in a fashion that ensures safety of involved personnel and clients who receive them.

Scope: Applicable to any sterile compounded preparations and the ingredients used to prepare them.

Definition(s):

 

USP : United States Pharmacopeia

CSP : Compounded Sterile Product

MFR : Master Formulation Record

Equipment: N/A

Procedure:

  • CSPs should only be prepared by those who are cleanroom certified
    • Compounder should be familiar with the master formulation and understand how to appropriately prepare sterile product prior to entering the cleanroom

 

  • Personnel must don appropriate PPE when preparing / repackaging CSPs

 

  • Non-sterile chemotherapy rated gloves should be utilized for unpacking and stocking chemotherapy drugs in the HD cleanroom

  • Master formulation provides instructions for packaging and storage and once prepared the CSP must be both packaged and labeled appropriately and have the necessary auxiliary labels
    • Any CSPs in a sterile vial should have a label on both the sterile glass vial and the pill vial it is being dispensed in
    • CSPs in a sterile vial should have a seal placed on top of the vial prior to dispensing
    • CSPs that are prepared in syringes should receive a sterile cap
    • CSPs that are in syringes and need to be protected from light should be stored in a light protect bag

  • Controlled substances that are prepared (i.e. butorphanol syringes) should be stored in the control closet, locked in the cabinet and can be signed out for transport to the appropriate Cubex

 

  • No expired CSPs shall be stored in the pharmacy for any reason
    • Any CSPs that are expired or will expire prior to the end of the treatment period for a prescription should be disposed of appropriately

 

  • CSPs should be packaged and transported in accordance with the MFR
    • If CSP requires refrigeration, it shall be shipped with ice packs in a cooler
      • Suggest overnight shipping to clients with refrigerated items
      • If client declines overnight, then put an extra ice pack into the cooler
    • Students shall be informed that the CSP required refrigeration and offered an ice pack to send home with the client

 

  • Any CSPs that are transported out of the pharmacy must have sufficient labeling to ensure anyone that utilizes it knows what medication it is, the lot number of the medication, and when it expires

 

  • CSPs being dispensed and transported home with the client must meet labeling requirements provided by federal government and state of Illinois


KeywordsPackage, transport, unpack, stock   Doc ID130900
OwnerJenny C.GroupUofI College of Veterinary Medicine Teaching Hospital
Created2023-09-06 14:26:51Updated2023-09-07 14:35:35
SitesUniversity of Illinois College of Veterinary Medicine Teaching Hospital
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