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Packaging and labeling

*Final container

Sterile until to the beyond use date Protected from chemical degradation; 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 ofmedication, 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 ingredientsb. Total volume of the compounded sterile preparationc. Beyond use dated. Appropriate route of administratione. 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 administrationa. Patient name and identification numberb. Patient locationc. Name and amount of drugs added and name of the admixture solutiond. Time and date of scheduled administratione. Time and date of preparationf. Administration instructionsg. Initials of person who prepare and check the IV admixture

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Verification of compounding accuracy and sterility

*Components must be assured to use the product:

a. Accuracy of its contentb. 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 bythe 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, theHandbook on Injectable Drugs, others)

b. Sterility considerations

o USP Chapter o 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

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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 refrigerationb. CSP was protected from lightc. No evidence of tamperingd. 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

a. Access to the buffer or clean areab. Decontamination of supplies in the anteroom areac. Storage of supplies not needed for scheduled operationsd. Use of carts to transfer supplies and preparationse. Use of particle generating objects, such as pencils, cardboard, and paperf. Traffic flowg. Policy for cosmetics and jewelryh. Procedures for hand washingi. Policy for food itemsj. Procedures for cleaning surfaces in the compounding environmentk. Policy for maintaining ISO class 5direct compounding are conditionsl. Handling of supplies within the direct compounding aream. Inspection and final preparation checking preparationn. Removal of preparations and supplies from the direct compounding areao. Environmental monitoring

Compliance with USP chapter

*First quarter of 2009 (more than 6 months after the revision of chapter

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

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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