Chapter Phar 15

COMPOUNDING PHARMACEUTICALS

Phar 15.01   Intent.

Phar 15.015   Definitions.

Subchapter I — General

Phar 15.10   Facilities.

Phar 15.11   Equipment and Drug Preparation Containers.

Phar 15.12   Records of compounding.

Phar 15.13   Quality control.

Phar 15.14   Training, Policies, and Procedures.

Phar 15.15   Labeling.

Phar 15.16   Component Selection.

Phar 15.17   Non-patient specific compounding.

Subchapter II — Non-sterile Compounding

Phar 15.20   Component Selection.

Phar 15.21   Assigning BUD.

Subchapter III — Sterile Compounding

Phar 15.30   Definitions.

Phar 15.31   Facility design and environmental controls.

Phar 15.32   Personnel hygiene, garbing and protective gear.

Phar 15.33   Cleaning and Disinfecting the Compounding Area and Supplies.

Phar 15.34   Immediate-use compounded sterile preparations.