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This newsletter is a continuation of our series on the proposed USP <795> Pharmaceutical Compounding—Nonsterile Preparations. Here, we look at some comments on selected aspects of Sections 7 and 8. The numbers on the left are the same as those actually in the chapter. Only those items with comments are reproduced.
7. SOPS AND MASTER FORMULATION AND COMPOUNDING RECORDS
| 385 | | 7.2 Creating Master Formulation Records |
| 394 | | Box 7-1. Master Formulation Record
A Master Formulation Record must include at least the following information:
- Name, strength, and dosage form of the CNSP
- Physical description of the final CNSP
- Ingredient identities and amounts, and container-closure systems, including necessary characteristics of components (e.g., particle size, salt form, purity grade, solubility)
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+Particle size is not always available on a C of A and nothing is provided here concerning how it is to be expressed. Terms such as:
- "fine powder", etc. vs
- 100-200 mesh, vs
- 50-100 micron vs
- nlt 90% less than 500 microns, etc.
If the components are to be used in preparing solutions, it may not be necessary to know the particle size. Would suggest adding (e.g., particle size as necessary and appropriate, salt form�.etc.)
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| 395 | | 7.3 Creating Compounding Records |
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| 409 | | Box 7-2. Compounding Records
- Name, vendor or manufacturer, lot number, and expiration date of each ingredient and container-closure system
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| +Expiration dates of container-closure systems are not usually available. |
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| 411 | | 8. RELEASE TESTING |
| 418 | | �������All checks and inspections, and any |
| 419 | | other tests necessary to ensure the quality of the CNSP (e.g., pH, assays), |
| 420 | | must be detailed in the facility's SOPs and completed before release. |
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| +If a compounded preparation is sent out for assay, the results may not be back before the patient needs the medication and the BUD is being used up. Recommend dispensing and following up if the assay is OOS. The loss of a few days therapy is potentially more problematic than any clinical significance of a compounded preparation assaying at 89% or 111% and needing to be recalled. |
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| ADDENDUM
The following comment was a late submission to last week's Newsletter: |
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| 237 | | 2. The CVE must be certified annually. If the CVE is not equipped with an |
| 238 | | exhaust alarm, the device should be certified every 6 months according to |
| 239 | | requirements such as the current Controlled Environment Testing |
| 240 | | Association (CETA) or American Society of Heating, Refrigerating, and Air- |
| 241 | | Conditioning Engineers (ASHRE) guidelines, or other jurisdictional standards. |
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| +What is being certified? A standard needs to point to specific documents. This is far too general to be incorporated into a standard. Which CETA guide? What ASHRE guidelines? Why reference "jurisdictional standards" when the other two are guides and guidelines. A standard needs to be specific in requirements, and these statements do not meet the criteria of being specific. |
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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