Packaging and Transport USP 795

Non-Sterile Compounding <795>

Packaging and Transport

Non-Sterile Compounding <795>



Purpose/ Applicability: To provide processes and procedures for proper packaging, storage and transport of non-sterile compounded products.

Scope: Applies to non-sterile compounded preparations and the personnel handling CNSPs.

Definition(s):

CNSP : Compounded non-sterile product

MFR: Master Formulation Record

 

Equipment:

  • N/A

Procedure:

  1. Compounded non-sterile products should be packaged and stored in a manner to prevent damage, leakage, contamination and degradation once prepared. Personnel should select and use packaging materials that will maintain the physical and chemical integrity and integrity of the compound.

 

  1. CNSPs should be packaged and transported in accordance with the MFR.
    1. Veterinary staff who compound after hours are required to document everything appropriately on the compounding record and place all appropriate stickers on the medication bottle prior to dispensing.

 

  1. Controlled substances that are prepared for non-specific patient use (i.e. tramadol suspension) should be stored in the appropriate Cubex machine, or locked in the cabinet.
    1. Veterinary staff who compound controlled substances after hours are required to document everything appropriately on the compounding record, sign out the controlled substances, and place all appropriate stickers on the medication bottle prior to dispensing.

  2. CNSPs should be packaged and transported in accordance with the MFR
    1. If CNSPs requires refrigeration, it shall be shipped with ice packs in a cooler
      1. Suggest overnight shipping to clients with refrigerated items
      2. If client declines overnight, then put an extra ice pack into the cooler
    2. Students shall be informed that the CNSPs require refrigeration and offered an ice pack to send home with the client.
    3. Any CNSPs that are light sensitive needs to be labeled accordingly, and stored and transported in an amber bag or a vial to protect from light.

 

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

 

  1. CNSPs that are dispensed for ward stock should have appropriate labeling, stickers, and expiration dates.
    1. It is the responsibility of the service to dispose of the medication by the expiration date.

 

  1. CNSPs 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.

  2. CNSPs being dispensed and transported home with the client must meet labeling requirements provided by federal government and state of Illinois.

 

 

Report any adverse event or product defect using Form FDA 1932a within 15 business days

 



Keywordspackaging, handling, leak   Doc ID130890
OwnerJenny C.GroupUofI College of Veterinary Medicine Teaching Hospital
Created2023-09-06 13:43:01Updated2023-09-07 14:33:29
SitesUniversity of Illinois College of Veterinary Medicine Teaching Hospital
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