USP 800 and the Benefits of Manufactured Unit Dose Medications Over Repackaging

By American Health Packaging

Many hospitals are currently prioritizing USP General Chapter <800> compliance. This means facilities across the country are revising medication procurement strategies to ensure they are able to meet their supply needs while providing adequate protections for pharmacy staff, caregivers, and patients.
While repackaging hazardous drugs in-house may seem a suitable option, this requires special considerations related to gowning, management of bulk inventory, and expenditures on capital equipment. Third-party repackagers may allow some pain points to be avoided, still require the management of bulk product and may come with excessive lead times.
Manufactured unit dose, from a provider such as American Health Packaging, may provide advantages. Staff receives pre-packaged UD produced by reputable manufacturer with a track record of quality and compliance. This allows them more time by freeing up resources which can be dedicated to patient care. In addition, AHP UD can often be obtained in a manner of days from partner GPOs and wholesalers.
As part of our industry-leading oral solid UD portfolio, American Health Packaging offers a selection of various antineoplastic and hazardous drugs. The pamphlet available for download on this page serves as a reference guide for these products. Classifications have previously been defined by the National Institute for Occupational Safety and Health (NIOSH). According to “Table 5. Personal protective equipment and engineering controls for working with hazardous drugs in healthcare settings” within “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016”, administration of an intact tablet or capsule from unit dose packaging does not require double chemo-therapy gloves, protective gown, eye/face protection, or respiratory protection.
Products within our reference guide are listed in three categories based on their NIOSH classification:


Group 1: Antineoplastic Drugs

Antineoplastic Drugs (AHFS Classification 10:00) ASHP/AHFS DI 2016] Many of these drugs may pose a reproductive risk for susceptible populations.

Group 2: Non-Antineoplastic Drugs

Non-Antineoplastic Drugs that meet one or more of the NIOSH criteria for hazardous drugs. Some of these drugs may also pose a reproductive risk for susceptible populations.

Group 3: Possible Reproductive Risk 

Primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breastfeeding, because some of these drugs may be present in breast milk.
Contact us to learn more about how AHP products can help support an effective USP General Chapter <800> compliance strategy.

AHP Unit Dose as Part of a Strategy for Obtaining Compliant Hazardous Drugs

New chapter guidelines mean that your pharmacy could face challenges in managing a revised unit dose procurement strategy. With staff and patient safety being top priorities for any hospital, obtaining pre-packaged UD provides an efficient, effective alternative to repackaging from bulk product. Download our reference guide featuring a list of available AHP UD from groups 1-3.


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