With this issue, we are beginning a multi-part series looking at the proposed USP <795> Pharmaceutical Compounding—Nonsterile Preparations. Here is a comparison of the major subheadings of the "Current" and the "Proposed" chapter.
|Introduction||1. Introduction and scope|
|Categories of Compounding||2. Personnel qualifications‑training,|
evaluation, and Requalification
|Responsibilities of the Compounder||3. Personal Hygiene and Garbing|
|Compounding Process||4. Buildings and facilities|
|Compounding Facilities||5. Cleaning and sanitizing|
|Compounding Equipment||6. Equipment and components|
|Component Selection, Handling, and Storage||7. SOPS and master formulation|
and compounding records
|Stability Criteria and Beyond-use|
|8. Release testing|
|Packaging and Drug Preparation Containers||9. Labeling|
|Compounding Documentation||10. Establishing beyond-use dates|
|Quality Control||11. Quality assurance and quality|
|Patient Counseling||12. CNSP handling, packaging,|
storage, and transport
|Training||13. Complaint handling and|
adverse event reporting
|Compounding for Animal Patients||14. Documentation|
Observations at the 30,000 foot level:
- Proposed sections are numbered, current sections are not.
- "Scope" of the Chapter has been added.
- "Categories of Compounding" has been removed.
- Note: Apparently, a pharmacy that only mixes two oral liquids together or two ointments/creams together in a day or week must adhere to all of <795>. That is not appropriate or necessary.
- This is one of the primary omissions in this proposed chapter. As written, it is not reasonable to apply it to pharmacies doing 1 compound a day as well as to pharmacies doing 100 compounds a day; they are different facilities with different requirements. Also, using commercial concentrates (hormone cream concentrates from companies) that are designed to protect personnel minimize or negate some of the requirements in the chapter.
- "Responsibilities of the Compounder" has been changed to "2. Personnel Qualifications-Training, Evaluation, and Requalification".
- "3. Personal Hygiene and Garbing" section has been added.
- "5. Cleaning and Sanitizing" has been added.
- "Compounding Facilities" has been changed to "4. Buildings and Facilities".
- The proposed chapter appears to be closely patterned after <797>.
- "Compounding Processes" has been removed.
- "Component Equipment" and "Component Selection, Handling, and Storage" sections have been combined into "6. Equipment and Components".
- "Patient Counseling" has been removed and possibly replaced with "Complaint Handling and Adverse Event Reporting".
- "Compounding Documentation" has been expanded into two sections: "(1) SOPs and Master Formulation and Compounding Records", and "(2) Documentation".
- The section "Compounding for Animal Patients" has been removed with only limited information in the "1. Introduction and Scope" section.
- A new section "8. Release Testing" has been added.
- Some sections have been renamed.
- An "Appendix of Acronyms" has been added.
- There is a lot of duplication and basic teaching in this proposed chapter that can be said more briefly and concisely as standards.
There are some positive changes in the proposed chapter as well as ill-advised proposed changes. Over the next few weeks, we will look at the different sections for input to the Expert Committee as well as for those State Boards of Pharmacy that are preparing their own Nonsterile Compounding Regulations. Please go to the following website and download your own free copy of the proposed chapter and send your comments/concerns to USP for consideration.
Also, everyone is encouraged to download and read the Comments of the Nonsterile Consensus Group and BUD Comparisons found on the CompoundingToday website. Don't forget, it's up to you to let the USP committee know your thoughts on this proposed chapter.
Loyd V. Allen, Jr., PhD, RPh
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
Tip of the Week
One might ask, "What is the application of Will Rogers' statement here?" Well, it seems that when standards are set, a lot of money must be spent by those affected by the standards. This is perfectly fine when the standards are reasonable and appropriately justified and documented. Otherwise, the "standards-setter" is being generous with the "compounding pharmacists' money". This is of great concern when there are only minimal issues in some cases.