| 119 | | Compounding personnel must maintain personal hygiene. Individuals that |
| 120 | | may have a higher risk of contaminating the CNSP and the environment |
| 121 | | (e.g., due to rashes, sunburn, recent tattoos or oozing sores, conjunctivitis, |
| 122 | | active respiratory infection) must report these conditions to the designated |
| 123 | | person. The designated person must evaluate whether these individuals will |
| 124 | | be allowed to work in compounding areas before their conditions are |
| 125 | | resolved because of the risk of contaminating the environment and CNSPs. |
| |
| +See our previous discussion in Section 1.1, Lines 50 through 53, in our April 27, 2018 Newsletter. |
| |
| 126 | | 3.1 Personnel Preparation |
| 127 | | Personnel engaged in compounding must maintain hand hygiene and wear |
| 128 | | clean clothing required for the type of compounding performed. |
| 129 | | Before entering a designated compounding area, compounding staff must |
| 130 | | remove any items that are not easily cleanable and that might interfere with |
| 131 | | garbing. At a minimum, personnel must: |
| 132 | | • Remove personal outer garments (e.g., bandanas, coats, hats, jackets, |
| 133 | | scarves, sweaters, vests) |
| 134 | | • Remove all hand, wrist, and other exposed jewelry or piercing that can |
| 135 | | interfere with the effectiveness of the garb or hand hygiene (e.g., |
| 136 | | watches, rings that may tear gloves) |
| 137 | | • Remove headphones and earphones |
| 138 | | • Keep nails clean and neatly trimmed to minimize particle shedding and |
| 139 | | avoid glove punctures |
| |
| +Some of the above may not be necessary for low numbers of simple nonsterile compounding, and lead to excessive costs with no reasonable benefit. |
| |
| 140 | | 3.2 Hand Hygiene |
| 147 | | Box 3-1. Hand Hygiene Procedures |
| 148 | | 3.3 Garb and Glove Requirements |
| 149 | | Gloves are required to be worn for all compounding activities. Other garb |
| 150 | | (e.g., shoe covers, head and facial hair covers, face masks, gowns) must be |
| 151 | | appropriate for the type of compounding performed as needed for the |
| 152 | | protection of personnel from chemical exposures and for prevention of |
| 153 | | preparation contamination. Garb must be stored to prevent contamination |
| 154 | | (e.g., away from sinks to avoid splashing onto garb). Visibly soiled garb or |
| 155 | | garb with tears or punctures must be changed immediately. |
| |
| +If understood correctly, the only required item to be worn is gloves; other items must be appropriate for the compounding situation. That sounds appropriate and reasonable. |
| |
| 165 | | 4. BUILDINGS AND FACILITIES |
| 166 | | Compounding facilities must have a space that is specifically designated for |
| 167 | | compounding. Areas related to nonsterile compounding must be separated |
| 168 | | from areas not directly related to compounding. Areas intended for |
| 169 | | nonsterile compounding must be separated and distinct from the areas |
| 170 | | intended for sterile compounding (see Pharmaceutical Compounding�Sterile |
| 171 | | Preparations <797>), except where permitted as described in <800>. |
| 172 | | Compounding areas used to compound hazardous CNSPs must not be used |
| 173 | | for compounding nonhazardous CNSPs (see <800>). |
| |
| +It is not clear what level of "separation" is required. If in a separate room with its own HVAC, etc., this is not reasonable for many small-scale compounders servicing patients throughout the U.S. doing only simple, occasional compounding. It would be fine for the large scale compounders but it is important to maintain patient access in all geographical areas. For many situations, it is not necessary to have a separate room, etc. It is too costly to build out, operate and the return on investment is not there...so patients will be without access to their compounded medications. This is true of both small hospital pharmacies and independent pharmacies. |
| |
| 174 | | Compounding facilities must be designed and controlled to provide a well- |
| 175 | | lighted working environment, with temperature and humidity controls for the |
| 176 | | comfort of compounding personnel wearing the required garb. Heating, |
| 177 | | ventilation, and air conditioning systems must be designed and controlled to |
| 178 | | prevent decomposition and contamination of chemicals, components, and |
| 179 | | CNSPs (see also 12. CNSP Handling, Packaging, Storage, and Transport). |
| 180 | | Temperature and humidity must be maintained as required for components |
| 181 | | and compounded preparations. |
| |
| +Humidity control is not necessarily required in USP APIs or USP Product Monographs except where it states to store in a dry place. A dry place is a place that does not exceed 40% average relative humidity at 20�C (68� F) or the equivalent water vapor pressure at other temperatures.
The determination may be made by direct measurement at the place. Determination is based on NLT 12 equally spaced measurements that encompass either a season, a year, or, where recorded data demonstrate, the storage period of the article. There may be values of up to 45% relative humidity provided that the average value does not exceed 40% relative humidity. Storage in a Container validated to protect the article from moisture vapor, including storage in bulk, is considered a dry place.
The geographical variations in the U.S. from coastal, gulf, desert, etc. results in pharmacies with low humidity and some with high humidity. Once a door is opened, the humidity inside the facility changes. The reference to a humidity probably should be removed.
One must also consider that when ingredients and finished preparations are in "Tight Containers," room humidity is generally a moot point unless the container is repeatedly opened. |
