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Vertical 3.594” x 8.75”
The ultimate responsibility for gThe ultimate responsibility for documentation and verification for The following guidelines shall be followed when selecting, han- Excerpts from USP Chapter <1191> on this topic will be dis- Third Page Horizontal 4.812” x 4.875”
documentation and verification for everything within the compounding pharmacy rests with the com- dling, and storing components for compounded preparations. cussed later. Vertical 2.313” x 8.75”
everything within the compounding pounder. 7. If a manufactured drug product is used as the source of
pharmacy rests with the compounder. 1. A USP, National Formulary, or Food Chemicals Codex sub- active ingredient, the drug product shall be manufactured in Quarter Page Horizontal 3.625” x 4.875”
All the activities in this article apply to both nonsterile and ster- stance is recommended. an FDA-registered facility.
that a process, procedure, or piece of equipment is func- ile compounding activities. 8. If compounding a dietary or nutritional supplement, USP
tioning properly and producing the expected results.d The 2. First, attempt to use components manufactured in a U.S. Chapter <795> must be followed as well as any federal and
act of verification of a compounding procedure involves checking Summary of Verification Food and Drug Administration (FDA)-registered facility. state requirements.
to ensure the calculations, weighing and measuring, order Verification of a compounding procedure involves checking to 9. If a component is derived from ruminant animals (e.g.,
of mixing, and compounding techniques and equipmente 3. Components should be accompanied by a Certificate of bovine, caprine, ovine), the supplier shall provide written
were appropriate and accurately performed. The quality of ensure that calculations, weighing and measuring, order of mixing, Analysis. assurance that the component is in compliance with all
ingredientsf should be verified upon receipt (e.g., Certificate of and compounding techniques were appropriate and accurately federal laws governing processing, use, and importation
Analysisf, manufacturer's label on commercial productsf, performed and recorded. It involves assurance and documenta- 4. Prepare official compounded preparations from ingredients requirements for these materials.
etc.). Verification may require outside laboratory testing when tion that a process, procedure, or piece of equipment is function- that meet requirements of the compendial monograph for 10. Compounding for humans will not include any item on the
in-house capabilities are not adequate. Equipment verification ing as it should and producing the expected results. Verification those individual ingredients for which monographs are avail- list of components that have been withdrawn or removed
methods are sometimes available from manufacturers of the spe- may require an outside laboratory to conduct tests to confirm the able. If not, components of high quality such as those that from the market for safety or efficacy reasons by the FDA
cific equipment or can be developed in-house. The responsibil- accuracy of the results. Process verification may include activities are chemically pure, analytical reagent grade, or American (see www.FDA.gov).
ity for assuring that equipment performance is verified, includ- such as weighing, measuring, blending, filling, sterilization, etc. Chemical Society–certified may be used. 11. Compounding for food-producing animals will not include
ing work completed by contractors, resides with the compound- any substance on the list of components prohibited for use in
erg. Excerpts from Component Selection, Handling, and Storage 5. Expiration dates on components from the manufacturer or food-producing animals.
under USP <795> will be discussed later. distributor can be used in compounding. 12. All components used in the compounding must be properly
stored.
6. For components without expiration dates assigned by the
manufacturer or supplier, the compounder shall label the
container with the date of receipt and assign a conserva-
tive expiration date, not to exceed three years after receipt.
dDocuments must be signed by an individual in a position specifi- Half Page Print Submission
cally authorized to do so; this should be detailed in specific SOPs.
The documents should be signed only after assurance that the spe- Procedure verification may include cleaning and other activities. Send Files to: [email protected] and copy [email protected]
cific process or procedure is functioning as it should or the piece of For the purposes of compounding, these processes are usually Preferred File Format: Press Ready PDF
equipment is operating appropriately and with its specifications to simply verified qualitatively. Equipment verification methods are Publication Trim Size: 8.5” x 10.875” (Allow .50” margin)
produce the desired result. sometimes available from manufacturers of the specific equip- Bleed: .125” on all sides
eAll activities should be verified by a second individual, if possible. ment or can be developed in-house. The responsibility for assuring Color: CMYK
Calculations should be double-checked for confirmation by a second that equipment performance is verified resides with compounding Blow-in cards and polybag inserts: Please call or email for rates.
person actually performing the calculations without looking at the personnel, but may be performed by contractors. Email Blast: $1 per email and $50 for artwork if needed.
original set.
fCertificates of Analysis should be obtained for every lot of sub- Excerpts and Summary from USP Chapter <795>
stance purchased and used in compounding. Upon receipt, the C of A Section Entitled Component Selection, Handling,
results should be evaluated to confirm the substances meet expected and Storage
standards. Comparison with USP or NF standards is optimal. For
commercial products, the label must contain an expiration date. (Note: The items listed in this section should be documented and/
The specifications for the product may be presented in the USP/NF. or verified as appropriate.)
However, it is not required to obtain the actual analytical results
from the manufacturer of the product.
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SOP’s in the following categories:
Administrative, Training, Safety,
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dures, Quality Assurance, Inventory
Control, Referenced Documents, &
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information about these SOP’s, call
1.800.757.4572 ext. 1 or 405.330.0094.
320 International Journal of Pharmaceutical Compounding www.IJPC.com www.IJPC.com International Journal of Pharmaceutical Compounding 321
Vol. 16 No. 4 | July/August 2012 Vol. 16 No. 4 | July/August 2012
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IJPC is the ONLY journal in the world dedicated to
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compound scientific journal. The journal contains content on:
of All Pharmacies USP <797> (sterile compounding), USP < 795> (non
Compound • Community pharmacy sterile compounding), USP <800>, Vet, Bio-identical
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Control, Hazardous Drugs, Investigational Drugs,
($22-25 Billion of • 10% of all prescriptions are and New Revisions to Current Chapters, including
All Prescriptions compounded (both hospitals USP <800>.
Are Compounded) and community pharmacy)
which represents between IJPC has published more articles on USP <797>
$22-25 billion dollars than any other publication in the world.
annually
*From NCPA
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271 282CAPhbhaaonrumgteaPcihsoapirnmeitaahce<y8AV0ier0:n>WtilhaatitoYnoUunNdeeerdUntoiteKdnoSwtates SfIrniomfampnltEeiylePerHeDeprmoarpaantSigooilnoumtoifoanTsifmoor lSoul p0e.5rf%iciGael l March/April 2018 01.24.18 Compounders on Capitol Hill Conference
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VOLUME 21 NO. 4 September/October 2018 07.31.18 ASHP’s Midyear
November/December 2018 09.26.18 ACA or IACP’s Educational Conference
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