| 5 | | Combining, admixing, diluting, pooling, reconstituting other than as provided |
| 6 | | in the manufacturer package insert, or otherwise altering a drug or bulk drug |
| 7 | | substance to create a nonsterile medication. Reconstituting a conventionally |
| 8 | | manufactured nonsterile product in accordance with the directions contained |
| 9 | | in the approved labeling provided by the product's manufacturer is not |
| 10 | | considered compounding as long as the product is prepared for an individual |
| 11 | | patient and not stored for future use. |
| |
| + | | Is it a requirement that the individual reconstituting the manufactured product wear gloves, mask, etc.? Oftentimes, antibiotics for reconstitution release powders into the air when opened for reconstitution. Seems potentially problematic�especially if the compounder may have respiratory issues. Even though it is understandable to omit them here, the problem still exists and possibly manufacturers should be required to add a labeling statement. |
| |
| + | | �not stored for future use�needs clarification. Is it really necessary? In the antibiotic reconstitution example, it is generally stored and administered over 14 days. The way it reads can be interpreted for immediate use. |
| |
| 12 | | 1.1 Scope |
| |
| 13 | | COMPOUNDED NONSTERILE PREPARATIONS AFFECTED |
| |
| 27 | | AFFECTED PERSONNEL AND SETTINGS |
| |
| 28 | | This chapter applies to all persons who prepare CNSPs and all places where |
| 29 | | CNSPs are prepared. This includes but is not limited to pharmacists, |
| 30 | | technicians, physicians, veterinarians, dentists, naturopaths, chiropractors, |
| 31 | | and nurses, in all places including but not limited to pharmacies, hospitals |
| 32 | | and other healthcare institutions, patient treatment sites, and physicians' or |
| 33 | | veterinarians' practice sites. |
| |
| + | | For non pharmacists/technicians, this is not realistic and most likely will not be implemented in states. Non-pharmacist professionals don't generally fall under the state boards of pharmacy and the specific professional boards of those professions see these standards, as well as those of 800, as problematic and will ignore them, as they have for other pharmacy professional practice standards. Recommend limiting the proposed chapter to pharmacy facilities. |
| |
| 34 | | The compounding facility's leadership and all personnel involved in |
| 35 | | preparing, storing, packaging, and transporting CNSPs are responsible for 1) |
| 36 | | ensuring that the applicable practices and quality standards in this chapter |
| 37 | | are continually and consistently applied to their operations, and 2) |
| 38 | | proactively identifying and remedying potential problems within their |
| 39 | | operations. Personnel engaged in the compounding of CNSPs must also |
| 40 | | comply with applicable laws and regulations of the regulatory jurisdiction. |
| 41 | | The compounding facility must designate one or more individuals (i.e., the |
| 42 | | designated person) to be responsible and accountable for the performance |
| 43 | | and operation of the facility and personnel in the preparation of CNSPs. The |
| 44 | | responsibilities of the designated person include but are not limited to: |
| 45 | | • Developing and implementing a training program |
| 46 | | • Routinely monitoring and observing compounding activities and taking |
| 47 | | immediate corrective action if deficient practices are observed |
| 48 | | • Demonstrating the procedures for personnel and observing and |
| 49 | | guiding personnel throughout the training process |
| 50 | | • Evaluating whether individuals with certain conditions, such as rashes |
| 51 | | or respiratory illnesses, will be allowed to work in compounding areas |
| |
| + | | Difficult to understand where "dry" rashes on the trunk, back, legs, etc. would be problematic here. Needs clarification. Possibly just limit to respiratory conditions, rashes in exposed areas, weeping rashes or those that may be contagious? |
| |
| 52 | | before their conditions are resolved because these conditions carry |
| 53 | | the risk of contaminating the environment and CNSPs |
| |
| + | | This last part of the entire sentence is not necessary as it is common knowledge. |
| |
| + | | It seems these standards are aimed at large and very large compounding facilities. However, many are small operations and all these standards may involve only one person doing the compounding. |
| |
| 62 | | 2. PERSONNEL QUALIFICATIONS-TRAINING, EVALUATION, AND |
| 63 | | REQUALIFICATION |
| |
| + | | Seems like a lot of this came from 797, but that is fine�.they will be somewhat harmonized. |
| |
| + | | There is no discussion or apparent allowance for training variances as to the type and extent of training for different sites. If only doing minimal "low-risk" compounding, why is it necessary to be trained in more technical and detailed compounding. The type and extent of training should be commensurate with the type and extent of compounding being done. |
