USP Chapter 795 FAQ

USP is the United States Pharmacopeia, an independent scientific organization that develops and disseminates public quality standards for medicines and other articles. USP standards are recognized in law and play a prominent role in federal and state compliance and enforcement activities.

Any drug that is recognized in the USP–NF must adhere to USP standards for identity, strength, quality, purity, packaging, and labeling or risk being deemed adulterated or misbranded under state and/or federal pharmacy laws. These provisions do not differentiate between commercially available and compounded medications.

Updated guidelines outlining requirements related to the compounding of non-sterile products. 

• Water-containing products, with a water activity factor greater than 0.6, have shorter beyond-use dates (BUDs).
• Due to shorter BUDs, the quantity of compounded medication prescribed may need to be decreased.
• Liquids do not have one default BUD since there are many different types (preserved, non-preserved, oil-based, water-based, etc.).

Covetrus’ pharmacies are compliant with USP 795 and 800 standards.  

• Expansion of our 503B catalog via third-party offerings.
• Smaller-size batches that are made more frequently.
• Prescriptions with smaller quantities and more frequent refills.
• Utilizing bracket testing to cover more ranges of affected products.
• The Covetrus prescription management platform allows the ordering of smaller quantities, when needed. Pet owners can also set up AutoShip to receive those smaller quantities more frequently.

If a prescription is written past the expiration date of the product, the practice will be contacted by our pharmacy to alert them of the dating and adjust the quantity prescribed. Our pharmacy has quality checks in place to help ensure the product dating would support the days’ supply dispensed on the prescription.

No. 503B outsourcing facilities are not impacted by the updated USP 795 chapter, as outsourcing facilities are regulated by cGMP standards. 

1. When searching the Product Catalog.
   • Select the “(i)” icon.

     

   • Select “Compound Dose Forms.”
   • The Maximum Shelf Life will be listed for all products that meet the search criteria.

     

2. When creating a Prescription.
   • First choose your patient

     

   • While searching for your product by active ingredient, select “Compound Dose Forms.”
     
   • The Maximum Shelf Life will be listed for all products that meet the search criteria.

     

Call Covetrus Compounding Pharmacies at 877-999-2838.