Beyond use dating for compounded pharmaceuticals


12-Jul-2016 19:07

(F) "Distribute" means to deal in, ship, transport, or deliver but does not include administering or dispensing a drug. (J) "Hospital" means an institution for the care and treatment of the sick and injured that is certified by the department of health and approved by the state board of pharmacy as proper to be entrusted with the custody of controlled substances and the professional use of controlled substances.(G) "Drug" has the same meaning as in section 4729.01 of the Revised Code. (K) "Hypodermic" means a hypodermic syringe or needle, or other instrument or device for the injection of medication. is a privately-owned resource developed to aid public understanding of USP 797. is not affiliated with, and its services are not endorsed by, The United States Pharmacopeial Convention (USP). USP 797 is an important publication issued by the United States Pharmacopeia.Widely agreed to improve the safety of the compounding environment and the products produced in that environment, USP 797 is mandated by some state boards of pharmacy and recommended by others.

beyond use dating for compounded pharmaceuticals-28

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Table 1: USP BUD = beyond use date; ISO = International Organization for Standardization; TPN = total parenteral nutrition.

Consequently, hospital design, construction and operations professionals should also become familiar with it.

Far-reaching regulation USP 797 is a far-reaching regulation that governs a wide range of pharmacy policies and procedures. Pharmacopoeia (USP), the regulation governs any pharmacy that prepares “compounded sterile preparations” (CSPs). Moreover, many large hospitals have several pharmacies–a main one and several satellite pharmacies–that will be affected.

It is designed both to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals.

As used in this chapter:(A) "Administer" means the direct application of a drug, whether by injection, inhalation, ingestion, or any other means to a person or an animal.While the safety of compounded sterile preparations (CSPs) has been an important topic in the practice of pharmacy for decades, the recent tragic deaths related to fungal contamination of preservative-free methylprednisolone injection have once again put the topic on the national stage.