Packaging and labeling *Final container Sterile until to the beyond use date Protected from chemical degradation;

n; light sensitive

*Choice of package should be taken into consideration Example: Ophthalmic preparation- packaged for drops to be instilled in the eye Irrigation solutions- need to accommodate sets: not to be confused IV administration containers

*Plastic containers Preferred; reduce cost and prevent breakage Not used if not compatible to preparation and heat sterilization of final product is required

*Proper labeling Important component of safe medication systems; identifies the medication, quantity of medication, and beyond use date If patient specific: for whom and the dose Supplementary information; to assure the dose is administered, stored, prepared properly Special techniques such as bold letters, larger font, color, capital letter on names and concentrations are used to avoid confusion from look a like to sound a like drug. There should be no too much information Specific Requirements for labeling sterile preparation: a. Name and amounts of ingredients b. Total volume of the compounded sterile preparation c. Beyond use date d. Appropriate route of administration e. Storage condition (refrigerate, protect from lights) f. Other information for safe use (cautionary statement, initials of responsible pharmacist, disposal instructions) Patient specific labelling- to assure proper drug administration a. Patient name and identification number b. Patient location c. Name and amount of drugs added and name of the admixture solution d. Time and date of scheduled administration e. Time and date of preparation f. Administration instructions g. Initials of person who prepare and check the IV admixture

Verification of compounding accuracy and sterility *Components must be assured to use the product: a. Accuracy of its content b. Sterility *Indirect methods of quality assurance is needed because it is not possible to wait for the results of test to measure the content or sterility for compounded preparations. a. Assuring the content of admixture matches what is printed or ordered on the label. Parenteral nutrition formulations are weighed through the specific gravity of the components. Deviation from calculated weight suggests wrong base or wrong volume solution used. b. Syringes and vial/ampuls used to compound the preparation placed on a tray are checked by the pharmacist for final checking to verify the use of its components and volume.

Storage and beyond use dating *Includes under which the preparation is stored and tome that elapsed between compounding and administration; chemical stability and sterility considerations. a. Chemical stability issues o Package insert, reliable reference (Extended Stability for Parenteral Drugs, the Handbook on Injectable Drugs, others)

b. Sterility considerations o o USP Chapter <797> Absence of passing sterility Low risk level preparations: beyond use dating of 48 hours at controlled room temperature, 14 days at cold temperature and 45 days in solid frozen state at -20C or colder Medium risk level preparations: beyond use date is shorter, 30 hours at controlled room temperature, 9 days at controlled temperature, but still 45 days frozen. High risk preparations: beyond use dating should not exceed than 24 hours at controlled room temperature or 3 days at cold temperature and 45 days frozen unless sterility testing provides evidence BEYOND USE DATE SHOULD BE PROVIDED ON THE LABEL OF THE COMPOUNDED STERILE PREPARATION TO PROTECT THE PATIENT

Maintaining the quality after the preparation leaves the pharmacy *Proper storage after the dose is received should be assured. *It must be stored in a refrigerator. *Pharmacy assumes the responsibility for delivery and storage of CSP. If not possible use shorter beyond use dating *Another challenge is the reuse of preparation other than the original patient *Examples of consideration to see if CSP is reused : a. CSP was maintained under continuous refrigeration b. CSP was protected from light c. No evidence of tampering d. Time remaining before originally assigned beyond use date and time

Standard operating procedures *To assure quality of the environment and operator technique used to compound sterile preparations *Recommended SOPs: USP Chapter <797> a. b. c. d. e. f. g. h. i. j. k. l. m. n. o. Access to the buffer or clean area Decontamination of supplies in the anteroom area Storage of supplies not needed for scheduled operations Use of carts to transfer supplies and preparations Use of particle generating objects, such as pencils, cardboard, and paper Traffic flow Policy for cosmetics and jewelry Procedures for hand washing Policy for food items Procedures for cleaning surfaces in the compounding environment Policy for maintaining ISO class 5direct compounding are conditions Handling of supplies within the direct compounding area Inspection and final preparation checking preparation Removal of preparations and supplies from the direct compounding area Environmental monitoring

Compliance with USP chapter <797> *First quarter of 2009 (more than 6 months after the revision of chapter <797> A survey showed that 262 hospital pharmacies of various U.S. states are more conversant and compliant of this chapter Only 24% of respondents reported their pharmacy meets or exceeds all the requirement of Chapter 797 40% they would be fully compliant within 6 months

25% said it would take them 6 months to a year for full compliance 61% of state board of pharmacy inspectors asked about compliance with USP Chapter 797 60% hospital pharmacy reported that they have a cleanroom with a separate HEPA filtration system 90%clean their cleanroom on a daily basis 69% of hospital pharmacy have environmental monitoring (EM) plan 71% plan to implement an EM plan in the near future 85% hospital pharmacy train sterile compounding employees at hiring 68% conducting annual training