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General Statement on Pharmaceutical Compounding (8.1)

General Statement on Pharmaceutical Compounding (8.1) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Manufacturing and Repacking

8.1

POLICY & PROCEDURE




Effective Date:

October 2003
⌧Pharmacy  Policy Manual
Chapter: Manufacturing/Repack
Operations Procedure Manual
Chapter:

Policy: 8.1
Original
⌧Revision 1/11
Page 1
Of 3
Title: General Statement on Pharmaceutical
Compounding


I. PURPOSE: To ensure all compounded pharmaceutical products are prepared accurately
and consistently using safe formulas for patient use.

II. POLICY: All compounded products must be prepared using formulas that are
documented and reviewed for safety and stability by a qualified Pharmacist and the
compounding steps are done by a qualified technician under the supervision of a pharmacist.

III. FORM: Example Manufacturing form from Compounding Database

IV. PROCEDURE:
A. Prior to preparation of a manufactured product, a master formula must be created in
the compounding database.
1. All formulas are verified by a pharmacist and double checked by a second
pharmacist or PHA.
2. Elements of the master formula include the following information
a. What to use (ingredients)
b. How much to use (weight or volume).
c. Procedure (order and procedure for mixing).
d. Equipment to be used.
e. Amount to prepare (batch size).
f. Container to be used for the product (glass, plastic, etc.).
g. Type of closure.
h. Labeling.
i. Type of testing (if necessary).
j. Time to prepare.
k. Time to package.
l. Control number.
m. Expiration date.
n. Section for signature and date of technician who manufactured the
product
o. Section for final pharmacist check and release.
p. Reference
q. Initials of RPh who verified the references.
3. Product control sheets are printed from the compounding database for each
item prepared (see attached example)
B. Before starting to prepare the product, the technician will:
1. Print a copy of the product control sheet from the compounding database.
2. Obtain the needed ingredients.
3. Obtain the proper containers and closures.
4. Write the following information in the manufacturing logbook:

POLICY & PROCEDURE




Effective Date:

October 2003
⌧Pharmacy  Policy Manual
Chapter: Manufacturing/Repack
Operations Procedure Manual
Chapter:

Policy: 8.1
Original
⌧Revision 1/11
Page 2
Of 3
Title: General Statement on Pharmaceutical
Compounding

a. The product description, strength, volume, quantity prepared, and
technician initials.
5. Write the following information on the Product Control Sheet:
a. Ingredients, manufacturer of ingredient and lot number used, and
technician initials.
6. Prepare the needed labels with the following information:
a. The product description, strength, volume, expiration date, lot number,
and any auxiliary label information (i.e. refrigerate, protect from light,
for oral use only, etc).
C. After all ingredients are present in the needed amounts; the technician will begin to
prepare the product by washing their hands and measuring out the ingredients in the
proper order.
D. Finished products that have been properly labeled are quarantined until the
pharmacist has approved them for release.
E. All dishes used to prepare products should be cleaned the same day by the technician
who used them.
F. The pharmacist will verify that the product was prepared correctly and document as
follows:
1. Verify that measurements are done correctly, that the correct ingredients are
used and the lot number of ingredients are accurately documented by the
technician. Documentation of this check is made by recording his/her initials
in the checked by column on the product control sheet.
2. Verify that labeling and containers used are correct and that finished product
is of good quality.
3. Approve product for release by recording initials on “Approved for Release”
line of product control sheet and signing the manufacturing logbook.
G. The technician responsible for preparing manufactured products shall ensure that an
adequate inventory of chemicals and supplies are available to prepare manufactured
items. Upon completion of the manufacturing process, the technician will assess the
inventory of chemicals and supplies remaining and initiate an inventory request at
that time if the stock on hand is insufficient to prepare the next batch.

POLICY & PROCEDURE




Effective Date:

October 2003
⌧Pharmacy  Policy Manual
Chapter: Manufacturing/Repack
Operations Procedure Manual
Chapter:

Policy: 8.1
Original
⌧Revision 1/11
Page 3
Of 3
Title: General Statement on Pharmaceutical
Compounding


V. COORDINATION:
A. AUTHORED BY: Dave Musa, Assistant Director of Pharmacy
B. COMMITTEE APPROVAL BY:


Approved By:_______________________________
Director of Pharmacy

Date:__________