USP Chapters 795 and 797

USP = 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 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 branded and compounded medications.

Updated guidelines specifying new default beyond-use dates (BUDs) of compounded products. USP 795 addresses non-sterile products while USP 797 addresses sterile products

• Water-containing products, with activity factor greater than 0.6, have shorter dating (BUD).
• The quantity of compounded medication prescribed will likely need to be decreased and more refills added.
• There is a reduced offering of flavors in accordance with these chapters.
• Liquids do not have one default BUD since there are many different types (preserved, non-preserved, oil based, water based, etc .).

Covetrus is compliant with USP standards, including the USP 795, 797, and 800 standards that have come about in the past couple of years. Our facilities conduct environmental and personnel monitoring.

• Evaluation and testing to extend beyond-use dating (BUD).
• For sterile compounds, we have an in-house lab so we do not have to send our products out for sterility testing, which expedites the process and allows more time for the end-user to use the product before BUD.
• Expansion of our 503B catalog.
• 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.
• Our Covetrus Prescription Management Platform allows veterinarians to easily update patient prescriptions to order smaller quantities when needed. Patients can also set up auto-ship to receive those smaller quantities more frequently.

No, new prescriptions will only be needed if we are making a change to the product, for example, switching from a water-based liquid to an oil-based preparation. All prescriptions written prior to November 1 will continue to be filled as written unless the pharmacy contacts the practice for notification of a change in the formulation of the product.

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. Our 503B outsourcing facility, Atlas Pharmaceuticals, is not impacted by the updated USP 795 and 797 chapters as this pharmacy is regulated by cGMP standards.

Call Covetrus Compounding Pharmacies at (877) 518-4589.