USP 797 & 800

The types of pharmacies in a typical hospital

There are two types of pharmacies in the typical hospital. There is the one which you are already familiar that resembles a store. The other is called a "compounding pharmacy" and is not at all like the store. The compounding pharmacy is an isolated and stringently monitored laboratory where the hospital prepares the formulations or "compounds" used for the parenteral treatment of patients. Parenteral means to be injected intravenous, intramuscular, or subcutaneous and these medicines come with their own dangers and concerns. These laboratories also formulate hazardous drugs such as chemotherapy or radiopharmaceuticals.

Compounding Pharmacy Dangers

Since these medicines are mixed and dosed to create IV solutions specifically for the patient and how they are administered, they must be kept strictly sterile. Pharmaceuticals that enter intravenously do not have the same level of assistance from the immune system. In recent years, some newer treatments have emerged that go beyond traditional chemistry and are more like portions of once living materials. These are generically called biologics and must be protected from the usual sterilization chemicals or processes common for non-viable pharmaceuticals.

What is the USP?

The United States Pharmacopeial Convention (USP) is a non- profit scientific organization founded in 1820 in Washington, D.C., that develops and disseminates public quality standards for medicines. USP's primary compedia of standards are the United States Pharmacopeial and the National Formulary (USP-NF) which are widely accepted as the authority regarding drug safety.

Buffer Area rated ISO 7 with HEPA Filters and SAF fixtures in the ceiling. NOTE: Pass through in center.

Concerns

These lab spaces formulate medicines for many patients each day and the base materials are many times more potent than what is given to the patient. Consequently, these concentrated base materials must be carefully handled in order to ensure proper dosing. A single small grain of, say a chemotherapy medicine, finding its way into another patient's dose could have catastrophic results. Similarly, if it is bad for the patient then what about the custodian or maintenance personnel who might, during a cleaning cycle, be exposed to a unique concoction of whatever is handled in that laboratory.

Regulation:

There are numerous oversight authorities such as OSHA, the Joint Commission along with national and local governments involved in regulating hospitals and specifically the hospital pharmacy space. When it comes to pharmaceuticals however, most of these authorities look to the USP for recommended practices for the safe handling of pharmaceuticals.

Cleaner Space Better Fixtures ISO2 ISO1 ISO3 ISO5 ISO4 ISO7 ISO6 ISO8 ISO9 Less Clean Space Lesser Rated Fixtures

Cleanroom Classifications

ISO14644-1

Direct Compounding Area Buffer-Area Ante-Area