USP <800> Questions and Answers

Questions posed within the weekly newsletter (info/subscribe) and responses provided by some members of the USP committee. The responses must go through channels, but we will post them as they are received. The questions are numbered as they appeared in the newsletter and will stay with each question. We will add and update these as they are received, so check back regularly!

1. What is potentially covered in the phrase "not limited to"?

2. Does "included personnel" also include drivers, custodians, inspectors, etc?

3. Is the patient bedside included in administration?

4. Regarding transport, can HDs be transported in tubes, robots, patient carts, etc? If so, which ones?

5. Is the nursing station where HDs may be stored included in "entities"?

6. What is required of a nursing home for drug storage and administration?

7. In a nursing home, are there requirements for the patient's room/apartment?

8. What mechanism is to be used to gain compliance by all the non-pharmacy facilities (physicians offices, nursing homes, retirement centers, etc)?

9. Where does the DESIGNATED PERSON obtain the necessary training for this job?

10. How much training is "sufficient" for a DESIGNATED PERSON?

11. How much time will be required for the DESIGNATED PERSON to do these activities each week?

12. How many "support personnel" will be required to maintain records, etc?

13. How will the "action limits" be set for establishing "risks"?

14. Is it necessary to post a sign at the front door to the store that HDs are in the pharmacy?

15. If not, at what point is posting required?

16. Regarding inventory segregation, I can't seem to find the location of the rule indicating we are required to keep 2 sets of inventory, one for CSP's and another for non-sterile preparations. Can you tell me where it is?

17. Does the separate storage requirements also apply to patient care areas (nursing stations, etc) since they may do a manipulation prior to or during administration, to delivery vehicles, etc.?

18. Section 5.2 states that "Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator in a negative pressure area…". Can "refrigerated non- antineoplastic HDs also be stored in that refrigerator or is a separate refrigerator required?

19. Regarding the USP<800> requirement to vent the SEC room outside, this may require a building permit since construction on a facility is involved. What recourse is there for the pharmacy if the city/county building permit to install an EXHAUST VENT from a HAZARDOUS compounding room in the pharmacy is denied?

20. Owner in a community pharmacy (present a lot of the hours but not all the time) provides compounding services and has one pharmacist and a tech. Facility is set up for 800 compounding.

  • -Is it necessary for the compounding pharmacist to remove ALL personal protective equipment (PPE) when they step out to answer the phone:
  • -Can they just de-glove if they answer a "handsfree" phone inside the room?
  • -The compounding pharmacist does all the patient counseling when new Rx's are picked up; does the pharmacist have to remove ALL PPE each time during the day for this?

21. There is a debate on whether nonhazardous and hazardous compounding can take place in separate hoods (C-PEC) inside the same room (C-SEC) or do they have to be in separate rooms (C-SEC)?

  • -In other words, do you have to have a hazardous room and a nonhazardous room?
  • -If so, do they both need sinks?
  • This is going to be so difficult to do in the majority of facilities. I'm, looking at upwards of $50,000 to renovate my lab. If we have to build separate rooms for nonhazardous and hazardous compounding, I'm not sure I can even do that in my current facility. I can't afford a new facility.

22. What does it mean when it states "A sink must be available for hand washing"? This is in reference to the C-PEC and C-SEC? Does "available" mean there must be a sink inside the C-SEC or can it be outside?

23. We are starting to remodel and still have questions. I have heard there may be changes to USP <800> that will impact our remodel operations. I don't want to spend money needlessly so how can we find out any changes quickly?

24. Regarding 5.3.1, if I only handle HD liquids or semisolids where no particles, aerosols or gases are produced, must this be done in a negative pressure room?

25. Why is it necessary to externally vent the C-PEC for Sterile HD compounding but not for NS HD compounding?

26. Section 5.3.2 specifically states that a LAFW cannot be used for compounding an antineoplastic HD. So, can a LAFW or CAI be used for compounding a non- antineoplastic HD?

27. If a BSC or CACI used for HDs is also used for non-HDs, what must be done after the non-HD preparations is placed in a protective outer wrapper and removed from the C-PEC? Must the wrapper and the non-HD preparation be handled as an HD preparation and the wrapper discarded as hazardous waste?

28. What is meant by "fixed walls"? Must they be totally solid? Can one use a soft-wall system utilizing a solid steel frame affixed to the floor and ceiling since this is "fixed"?

29. Does a "Fixed wall" have to go all the way to the floor?

30. If entering a negative-pressure HD buffer room through the positive-pressure non- HD buffer room and a "line of demarcation" is used to designate the area for donning and doffing PPE, is it critical which way the "air flows" in the buffer room as this will impact the placement of the exhausting air vents?

31. Is it correct that probably the final preparation and administration of most of the C-SCA HD CSPs will be in clinics, hospitals, physician offices, etc? If so, who will be enforcing these standards?

32. Regarding both "nonsterile" and "sterile" HD compounding, can "Gowns" be re-worn during the same day if a compounder must leave the HD compounding area for some reason? If so, how should it be "removed, stored, and donned"?

33. Is there an "evaluation tool" one can use for evaluating CSTD's performance when looking at independent, peer-reviewed studies and demonstrated containment reduction? Is there a "standard" for comparison?

34. I assume that a CSTD would be physically incompatible for compounding use due to physical dimensions, shape, composition, etc., but how can a CSTD be "chemically incompatible"?

35. What is "any measurable contamination"? Is it not dependent upon the analytical method used and what sensitivity is available? This doesn't seem logical or reasonable. It looks like "measurable" is a moving target.

36. It looks like the last two paragraphs in this section nullify any rational utilization of this section since there is no method to validate wipe sampling, there is no standard for acceptable limits for HD surface contamination etc.

37. Does this section mean that I have to obtain some cyclophosphamide, ifosfamide, methotrexate, fluorouracil or platinum-containing drugs to demonstrate that the wiping method is workable? If so, why would I logically want to add additional HDs to my work area. I thought the purpose was to minimize exposure, not increase it. Please explain.

38. I thought USP chapters were to be based on science. However, this chapter is absolutely not scientific! How can it be scientifically justified?

39. The last sentence in the "6. Environmental Quality and Control" section states, "Repeat the wipe sampling to validate that the deactivation/decontamination and cleaning steps have been effective". How can one "validate" something when the wipe testing cannot be validated since there is no certifying agency for vendors of wipe sample kits?

40. Is "wipe testing" required in every patient room in a hospital where HDs are administered?

41. Is "wipe testing" required in every clinical area where HDs are handled and/or administered to patients?

42. If an example of measurable contamination would be cyclophosphamide levels >1.00 ng/cm2, then is any action required if the result is only 0.99 ng/cm2.

43. How does one determine what is an "acceptable limit" for HD surface contamination since they do not exist?

44. Is it possible that the "acceptable limits" from baseline testing may be significantly different in different pharmacies since these are not defined? If so, then is it possible that an "action limit" level for one may actually be lower than the baseline level for another?

45. Regarding the C-SECs and the negative pressure requirements, does the chapter require you to have a gauge to monitor the differential between rooms or is it sufficient to verify only when a certifier checks the facility?

46. What is meant by "re-used"? Is it re-used if removed and then donned again when required to leave the area for a few minutes? Or does it mean re-used on a different day?

47. Who is going to enforce the "administration" requirements in a hospital, clinic, physicians offices, etc? The pharmacy?

48. What documentation is required that a gown will resist permeability by HDs?

49. How can one require providers (wholesalers, manufacturers, etc.) of either bulk chemicals or finished drug products to confirm and document that the surfaces of their shipping containers and unit packages are HD-free?

50. Are there any federal, state, or local requirements governing the packaging and shipping of HDs from a manufacturer?

51. Have there been any documented/published studies involving significant harm related to handling of commercially manufactured HDs in pharmacies?

52. Have there been any documented/published studies involving significant harm related to compounding of non-antineoplastic HDs in pharmacies?

53. Have there been any documented/published studies involving significant harm related to compounding of antineoplastic HDs in pharmacies?

54. Have there been any documented/published studies involving significant harm related to administration of HDs in patient-care settings?

55. I want to confirm that the initial nonsterile manipulations for sterile HD preparations do not need to be done in the sterile side hazardous side, but the sterilization needs to be done in the sterile environment.

56. In compounding pellets, these are compounded using a press, individually weighed, placed in glass vials, sealed then sterilized. Since they are in final dosage form, does the sterilizing equipment need to be in a hazardous buffer area (ISO Class 7)?

57. The same question applies for compounding testosterone cypionate and other oil injections, as follows: Can Testosterone Cypionate be dissolved in benzyl benzoate and benzyl alcohol in a nonsterile hazardous room?

58. When is a hazardous drug not a hazardous drug? For example, when a hazardous drug is dissolved in a liquid and cannot become an aerosol or gas, is it not a hazardous drug? Section 5.3.1 nonsterile states "a C-PEC is not required if manipulations are limited to handling final dosage forms that DO NOT produce particles, aerosols or gases."

59. If a hazardous drug is dissolved in a liquid, can it be taken into a regular cleanroom and filtered in a laminar flow (non-hazardous) hood?

60. The real question is can hazardous drugs that can no longer be an aerosol be put in final dosage form (e.g., filtered through sterilizing filters or be placed in vials for either autoclave or convection oven sterilization in a non-hazardous cleanroom)?

61. Why must we build a hazardous cleanroom where manipulations are done that really don't meet the requirements of a hazardous drug? It doesn't make sense to me.

62. How do we process HD powders in a sterile C-PEC or C-SEC since we don't want powders in that environment? How do we process these in a sterile or nonsterile environment? The design examples in USP 800 don't address these processes.

63. Can the cabinets used in the <800> rooms be the basic laminate cabinets used in most compounding labs?

64. Does the phrase "personnel of reproductive capability" refer to both male and female employees? How broadly is it to be interpreted?

65. Who is going to enforce and require a supplier of HDs to package the HD s in impervious plastic?

66. Regarding Table 4, if the unopened shipping package is damaged and is large, will large garbage bags suffice to enclose the shipping package? If so, should more than one be used?

67. Can the segregated HD return waiting area be the same as the regular HD Storage Area or must it be separate?

68. How can one find "impervious" packaging that is suitable for all situations? OR, does the formulation dictate the packaging due to various solvents, etc. Does impervious always mean "firm or hard" packaging or can it also mean "soft" packaging?

69. "10 Receiving" mentions a "tiered approach" but only gives the starting tier. ..what are the other "tiers"?

70. How "inclusive" and "extensive" is the labeling that is required for a HD at each point in the compounding, dispensing and administration process?

71. Regarding packaging, what criteria and data is available to evaluate the requirements in section "11.2"?

72. Regarding 11.3 Transport, does this also cover robotic dispensing equipment used in hospitals, etc. Must the HDs be transported manually?

73. Regarding 11.4 Disposal, are custodial personnel involved in waste removal and cleaning required to don all the required "PPE", etc.?

74. It seems like Section 12 Dispensing Final Dosage Forms refers only to "nonsterile" dosage forms. Are sterile dosage forms also included, as it seems that some may be handled here?

75. Regarding Section 14 Administering (paragraph 2), is it necessary for our nurses to don, doff, and discard PPE every time a room is entered for administration of a HD?

76. In a medical surveillance program, what can a PIC do if the employee does not want the employer to see their medical records?

77. In a medical surveillance program, what "health variables" should be followed over time for individual workers? (How detailed?)

78. In a medical surveillance program, who pays for all the tests, etc.?

79. In a medical surveillance program paid for by the employer, does the employer have access to and/or own the data?

80. In a medical surveillance program, how does an employer obtain data from the "unexposed workers" for comparison to the "exposed workers"?

81. What are the limitations on "potentially exposed" to HDs?