Editorial: The Seven Categories of Compounding
Soon to be published in the USP-NF and the USP-Pharmacists' Pharmacopeia will be a revision to USP General Chapter <1075> Good Compounding Practices, related to the seven categories of compounding. These have been presented at several different national meetings but I thought I would comment on them in this column.
First of all, since the categories are contained in chapter <1075>, which is a number greater than 1000, they are informational. If you recall, a General Chapter numbered less than 1000 is an enforceable standard and one numbered greater than 1000 is informational (but can still be enforceable). Some may also recall that "USP Chapter <1206> Sterile Drug Products for Home Use' was the one that was revised and is now "USP Chapter <797> Pharmaceutical Compounding-Sterile Preparations" and what was formerly "USP Chapter <1161> Pharmacy Compounding Practices" is now "USP Chapter <795> Pharmaceutical Compounding-Nonsterile Preparations". Both of these chapters were formerly "informational", but now are enforceable. More on the general chapters for compounding in later editorials but now let's look at the categories in compounding.
The introductory paragraph to this section of <1075> explains that these compounding categories are intended to provide an understanding among compounders when different forms of preparations are compounded. Inherent in these categories is the understanding that there are levels of training associated with each category.
The seven categories are as follows:
- Nonsterile-Simple
- Nonsterile-Complex
- Sterile-Risk Level 1
- Sterile-Risk Level 2
- Sterile-Risk Level 3
- Radiopharmaceuticals
- Veterinary
Category 1: Nonsterile-Simple generally consists of the mixing of two or more commercial products. It is an activity that should be capably done by any college of pharmacy graduate without any additional training. Obviously such factors as solubility, pH changes, etc. must be considered prior to the activity, but it is generally a relatively simple process.
Category 2: Nonsterile-Complex generally consists of compounding with bulk drug substances or when complex calculations are required. Depending upon the education received by the pharmacist, some will be knowledgeable and capable of performing complex nonsterile compounding. However, when working with microgram doses of potent drugs, extreme caution must be observed and adequate precautions taken to ensure the safety of the personnel involved.
Category 3: Sterile-Risk Level 1 is the same as Low-Risk Level in USP general chapter <797> Pharmacy Compounding-Sterile Preparations. This category involves only the transfer, measuring, and mixing manipulations with closed or sealed packaging systems that are performed promptly and attentively and are compounded with aseptic manipulations entirely within ISO Class 5 or better air quality using only sterile ingredients, products, components and devices.
Category 4: Sterile-Risk Level 2 is the same as Medium-Risk Level in USP general chapter <797> Pharmacy Compounding-Sterile Preparations. This category generally involves multiple individual or small doses of sterile products for administration either to multiple patients or to one patient on multiple occasions. The process includes complex aseptic manipulations other than the single-volume transfer and may be of unusually long duration. These preparations do not contain broad-spectrum bacteriostatic substances and are administered over several days. Adequate training and validation is critical for this category of compounding due to the potential risks involved.
Category 5: Sterile-Risk Level 3 is the same as High-Risk Level in USP general chapter <797> Pharmacy Compounding-Sterile Preparations. Generally, this category includes the use of nonsterile ingredients, devices and/or exposure to air quality inferior to ISO Class 5, etc. prior to terminal sterilization. This is obviously the most critical of all 7 categories because of the potential harm to patients. This category of compounding should be done ONLY by those pharmacists that have been adequately trained and validated for this category of compounding.
Category 6: Radiopharmaceuticals includes the compounding of any radioactive pharmaceutical. Training and validation not only in aseptic manipulations is generally required, but also proper training in the handling of radioactive agents.
Category 7: Veterinary compounding is compounding of preparations for animals. It is in a category of its own because of the unique set of knowledge that is important related to animals and how they handle and metabolize drugs. Training in veterinary compounding, both nonsterile and sterile, is important for the safety of the animals as well as for the personnel involved in the compounding.
Purpose and Potential Uses of the Categories
It is obvious that pharmacy compounding is growing and becoming more and more complex. Issues that are being addressed include quality, training, accreditation, certification, etc. In looking at these issues, it is apparent that if one is only doing nonsterile-complex compounding that this pharmacist does not necessarily need to have special training in sterile compounding. If the pharmacy wishes to become accredited, they should not be held to Category 5 standards for sterile compounding, etc. if they are only doing nonsterile complex compounding. Also, it may or may not be necessary for a category 4 and 5 pharmacy to meet all the different criteria for a category 2 pharmacy, depending upon how they are utilized. These are not "levels" of compounding, but rather they are "categories" of compounding. In other words, there is the capability of matching the activities of the compounding pharmacy with the different categories of compounding for accreditation, training, etc.
If certification ever comes into play, then there is the potential for certification in different compounding categories, rather than having to demonstrate a certain level of competence in all the categories.
If insurance carriers wish, they may be able to use these categories to match the risk with the compounding activities of the pharmacy. Why should Category 5 insurance rates be levied on a Category 1 or Category 2 compounding pharmacy? This may provide an opportunity of lower insurance rates for those compounding pharmacies doing Category 1, 2 and 3 compounding only.
In summary, these categories may change over time as more experience is gained in their utility and application. They may be combined in different forms, as the Pharmacy Compounding Accreditation Board has done. Compounding categories are simply a tool that can be used to enhance pharmacy compounding
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief | 