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OUTSOURCING STERILE PRODUCTS PREPARATION CONTRACTOR ASSESSMENT TOOL TM Developed with support from PharMEDium Services, LLC. Principles for Use When outsourcing sterile products preparation services,.

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Sterile compounding is further defined by USP to include any manipulation of a sterile or nonsterile product intended to produce a sterile final product. The Food and Drug Administration (FDA) recognizes compounding as a part of pharmacy practice, which does not fall within the agency's authority.

We can compound sterile ophthalmic drops, ointments, sprays, injections and pre-op solutions, including anesthetics, antibiotics, antioxidants, antivirals, cataract therapies, corticosteroids, ophthalmic decongestants, miotics, mydriatics, and lubricants.

Sterile compounding involves preparing medication in an environment free from bacteria, viruses, or any other potentially infectious microorganisms. Sterile compounding is used for preparations that will be administered either through an IV, injection, or directly into the eyes.

A laminar airflow hood is essential for the preparation of sterile products and should be located in the aseptic preparation area. Storage shelves, refrigerators, sinks, etc., should be located in a separate adjacent area to help reduce possible contamination.

Sterile compounded medications are intended to be used as injections, infusions, or application to the eye. Non-sterile medications include the production of solutions, suspensions, ointments, creams, powders, suppositories, capsules, and tablets.

The risk level depends on the CSPs compounding environment; its potential for microbial, chemical, and physical contamination; the nature of production of the CSP. It is the responsibility of personnel to determine the correct level.

Sterile compounding facilities must be designed, outfitted, and maintained properly to minimize the risk of contamination of CSPs. The required air quality must be achieved and maintained through PECs and secondary engineering controls (SECs).

Compounding is the creation of a pharmaceutical preparation—a drug—by a licensed pharmacist to meet the unique needs of an individual patient (either human or animal) when a commercially available drug does not meet those needs.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232