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Questions and Answers on USP 797
  • RJLG Question 1: Question on fingertip sampling: I have a question regarding fingertip sampling.  On page 34, the recommended action levels for microbial contamination states that the action levels for ISO Class 5 sampling is >3.  Yet when I look at the appendix I for gloved fingertip sampling it states that "All employees shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (0 cfu) no less than three times before initially being allowed to compound CSPs for human use".  I'm confused as to which one applies.  Can you clarify for me?  Thanks.  Click Here for Answer
  • RJLG Question 2: What is the minimum time for a settle plate sample. We are currently using 15 min is this enough.  Click Here for Answer 
  • RJLG Question 3: I work in a Nuclear Medicine Department and we use unit dose for everything but emergency scans. We have changed our policy to receive multiple separate syringes with varying activities to produce several single dose kits. During preparation aseptic techniques will be followed. The kit will be used within an hour, for only one patient and no more than two entries into any one vial. My concern is preparing an Ultra tag  kit for a G.I.Bleed.  If we follow the manufacturer's preparation and use the correct personal protective equipment are we covered under the immediate use exemption?  Click Here for Answer 
  • RJLG Question 4: We are a privately owned physicians office and do not have  pharmacy or pharmacist.  We have (2) RN's that are trained and certified to mix and give chemo drugs.  We follow NIOSH guidelines.  De we have to follow the USP797 guidelines? Click Here for Answer
  • RJLG Question 5: I read somewhere in the USP 797 that it was acceptable to mix a low volume of chemotherapy agents without a separate negative pressure room as long as CSTD's were used.  Is this correct?  Also--what is considered a low volume? Click Here for Answer
  • RJLG Question 6:   I have received some conflicting information regarding USP 797 standards related to the presence of a sink in an anteroom meeting ISO Class 7.  In reviewing the Revision Bulletin (copyright 2008), an ISO Class 7 buffer area shall not contain sinks or floor drains, but would the presence of a sink in a physically separate, positive pressure ISO Class 7 anteroom adjacent to a negative pressure ISO Class 7 buffer area somehow detract from the anteroom's ISO classification?  Specifically, I have a new hospital pharmacy which has provided certification documentation that the small anteroom leading into the hazardous drug preparation area (negative pressure ISO Class 7 buffer area containing ISO Class 5 PEC) meets the established guidelines for ISO Class 7 with the presence of a sink with a drain (located next to the doorway separating the anteroom from the buffer area).  This was in a pre-operational, non-dynamic state.  There are now some conflicting opinions about the sink and its impact on the ISO classification of the anteroom.  Any guidance on this situation would be much appreciated. Click Here for Answer
  • RJLG Question 7:   If a CACI is used as the PEC (The gloves used are part of the equipment) is gloved fingertip sampling required?   Is surface sampling required inside a CACI?  If so how frequently?  Click Here for Answer
  • RJLG Question 8:   We are a small home infusion pharmacy.  Approximately 2% of our patient base receives chemotherapy medications (primarily 5FU).  Do we need a negative pressure room if:  we compound/mix in a BSC, maintain a “safety zone” around the BSC within the clean room and utilize the PhaSeal product line when compounding?  Click Here for Answer
  • RJLG Question 9:  Is it acceptable to store a refrigerator in the anteroom under any circumstance?  The only answer I find in the chapter is “Placement of non-essential items within buffer and ante areas is determined by the impact on environmental quality as verified by monitoring.”  Is there a more straightforward answer to this question?  Did I miss the answer?  We need a refrigerator in our anteroom to store thawed premixed bags but don’t want to purchase if the answer is a definite no.   Click Here for Answer
  • RJLG Question 10: I have a question concerning the use of two different style hoods in the same area.
    1. Can a biological safety cabinet (BSC) and a laminar flow hood be in the same ISO 7 room that meets all other USP 797 requirements (ante-room etc.).  The BSC would not be used for hazardous products and is not vented to the outside air, but could be used short dated IV products (with exp</=24 hrs)?  We have an extra BSC and would like to use it in the same room are we violating any USP standards by using in the ISO 7 room?
    2. If the answer to question 1 is yes is there a specific room arrangement? (i.e. the two hoods can be next to each other in the same plane vs. opposite each other, minimum distance apart, etc)
     Click Here for Answer
  • RJLG Question 11: Is it appropriate to purchase air sampling equipment and perform our own ISO air testing for both viable and particle samples in a hospital setting?   Click Here for Answer
  • RJLG Question 12: If chemotherapy medications are stored in the negative pressure cleanroom, how are refrigerated chemotherapy meds supposed to be stored since refrigerators should not be placed in the clean room?  Do we have to build a separate negative pressure area for the refrigerator?  Click Here for Answer
  • RJLG Question 13: I need to know what storage requirements of supplies & drugs stored in the ante room. We purchased metal carts but not sure weather we can use new plastic bins to place on the metal carts?  Click Here for Answer  
  • RJLG Question 14: We are in the completion stage of a USP <797> compliant clean room. It will have 4 separate rooms: a preparation room, an ante room, and two buffer rooms (one for IV therapy and one, under negative pressure, for chemotherapy).   In addition, we have 2 separate satellites that compound chemotherapy, separate and distinct from our pharmacy clean room, on two different floors within the hospital.
    My questions relate to chemotherapy storage and are as follows:     
    1.   Where can we store our chemotherapy inventory?
    2.   Can chemotherapy be stored in the main pharmacy and in the satellites (within its original carton) if segregated from non-chemo products, but not in a negative pressure environment?
    3.   Must they be stored under negative pressure and if so, removed for the shipping carton and decontaminated prior to storage?
     Click Here for Answer
  • RJLG Question 15:  I have a question regarding the preparation of chemotherapy.  I have a negative pressure glove box that is vented to the outside.  It is currently in the same room as my positive pressure glove box.  If I have verification from the manufacturer that the glove box does not need to be in a clean room--do I need to place the chemo glove box in a negative pressure room?  Could I place it in a separate room without negative pressure.  If my room does not have negative pressure--where is the appropriate area to store my chemo meds?  I would appreciate any informatiion you can send.  Click Here for Answer
  • RJLG Question 16:  Do you have guidelines for what to do if laminar flow hood testing surface culture test results are positive?  Click Here for Answer
  • RJLG Question 17:  Chapter <797> states that “hazardous drugs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure”.  I work in a hospital with a separate negative pressure chemo room adjacent to a positive pressure ante room.  We use a separate refrigerator for chemotherapy drugs and it is only accessed by staff that are involved in the preparation and distribution of these drugs.  However, this refrigerator is too large to store in our negative pressure chemo room and would adversely impact our air quality.  Therefore, we store this refrigerator in a separate storage room.  Since the concern of volatilization of hazardous drugs is at room temperature and these drugs are refrigerated, is this an acceptable plan? Click Here for Answer
     
  • SS1 Question: I work for a VNA in the community. CVS pt education material for a multi-use vial (Prolixin) did not give any guidelines regarding how long the vial could be used after being opened. We also give Vit B12 injections and Haldol in the community (IM injections typically). We always follow sterility procedures and wipe with alcohol. My question is regarding the stability and sterility of the drug once the vial is opened. I was always taught 28 days. We date vials in the hospital setting and discard after 28 days. My concern in the community is as follows:
    1) Patients pay all or part of the drug expense. The pharmacy is dispensing vials that can last more than a year in some cases. Pts are not going to want to incur the added expense and hassle of refilling every month.
    2) I am concerned that some pharmacy programs will not refill if their guidelines are not following the 28 day rule.
    Then I contacted Bedford Laboratories, they agreed that the medication expiration date pertains to UNOPENED vials, but could only cite USP guidelines because their own material was silent on the subject. Our local (CVS) pharmacist stated it was the expiration date on the vial (which I don't believe is correct). Their corporate written material provided to pts was silent on the topic, although it did discuss storage.
     Do you have any comments on this subject or anyone I could check with?  Click Here for Answer
  • SS2 Question: http://www.usp797.org/Articles-APrimerOnUSP797-IJPC.htm
    In the primer article above, in the section titled "What Were the Main Events Leading Chapter ?"
    I'd like to know how to obtain the details of the comments and data presented.
    In addition, I'd like to know how I can find if there has been comment or participation by any physician practice organizations like the AMA and ASA.
    Click Here for Answer
  • SS3 Question: For non-sterile CSPs, what are common methods of sterilization? Click Here for Answer
  • SS4 Question: Your website is extremely helpful. My question is regarding compliance with USP797 in an outpatient diagnostic imaging facility injecting radiologic contrast media (either non-ionic or gadolinium based MRI) The purchase of a laminar flow work station(s) would not prove cost effective.  If the radiographic contrast media were ordered from the distributor in pre-filled syringes from the manufacturer (which confirms the dose was prepared in a sterile environment) would that be considered compliant with USP 797?SA. Click Here for Answer
  • SS5 Question: 1. If I have biological safety cabinet (BSC) or Glove in box within an ISO class 5 environment in a separate rooms does Viable Air Sampling need to be performed on that room and is garbing required?
    2. Does Proprietary Bag and Vial systems ( ADD-Vantage, Mini Bag Plus) require an ISO class 5 environment (Barrier Isolator or glove box) for attachment? Can someone please give me some clarity on the above 2 questions?SA.
    Click Here for Answer
  • SS6 Question: I have a question regarding oncology offices and the practice of mixing chemotherapeutic drugs for immediate use on patients.  According to the new June updates to 797 is this still an acceptable practice or do the offices need to mix chemo in barrier isolators or a clean room? Click Here for Answer
  • A1 Question: What is USP Chapter 797?  Click Here for Answer
  • A2 Question: How do I get a copy of USP Chapter 797? Click Here for Answer
  • A3 Question: Does USP Chapter 797 provide all I need to know about compounding sterile preparations?  Click Here for Answer
  • A4 Question: What is a "compounded sterile preparation" according to USP Chapter 797?  Click Here for Answer
  • A5 Question: Is USP Chapter 797 applicable just to pharmacies that compound sterile products?  Click Here for Answer
  • A6 Question: Are enforceable sterile compounding standards necessary?  Click Here for Answer
  • A7 Question: What can I do now to meet the requirements of USP Chapter 797?  Click Here for Answer
 
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