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(Learning about USP Chapter <800> in 10 minutes a week.)
5. Facilities and Engineering Controls
5.3.1 NONSTERILE Compounding
C-PEC
- A C-PEC is not required if only handling "final dosage forms" (counting, repackaging, etc.) that do not produce particles, aerosols, or gasses.
- C-PECs for nonsterile (NS) HDs must be either:
- Externally vented (preferred), OR
- Have redundant-HEPA filters in series.
- C-PECs include:
- Class I Biological Safety Cabinets (BSC)
- Containment Ventilated Enclosure (CVE)
- Class II BSC or a Compounding Aseptic Containment Isolator (CACI)
- For occasional NS HD compounding, a C-PEC for Sterile may be used but must be decontaminated, cleaned and disinfected before resuming sterile compounding.
- C-PEC for NS HD compounding does NOT require unidirectional airflow as it is not "classified air."
C-SEC
- The C-SEC where the C-PEC is located must have at least 12 air changes per hour (ACPH).
- The surfaces of
- ceilings,
- walls,
- floors,
- fixtures,
- shelving,
- counters and
- cabinets
- must be
- smooth,
- impervious,
- free from cracks and crevices and be
- nonshedding.
- The C-SEC must be
- Externally vented
- 12 ACHP
- Negative pressure between 0.01 and 0.03 inches of water column relative to adjacent areas.
NEXT WEEK:
5.3.2 Sterile Compounding
QUESTIONS RECIEVED FROM PHARMACISTS:
The following is a list of "unanswered questions" that need answers ASAP, as time is wasting. If you have a valid/documented answer, please send it to me at lallen@ijpc.com so we can post it. Thanks.
INTRODUCTION AND SCOPE
- What is potentially covered in the phrase "not limited to"?
- Does "included personnel" also include drivers, custodians, inspectors, etc.?
- Is the patient bedside included in administration?
- Regarding transport, can HDs be transported in tubes, robots, patient carts, etc.? If so, which ones?
- Is the nursing station where HDs may be stored included in "entities"?
- What is required of a nursing home for drug storage and administration?
- In a nursing home, are there requirements for the patient's room/apartment?
- What mechanism is to be used to gain compliance by all the non-pharmacy facilities (physician's offices, nursing homes, retirement centers, etc.)?
RESPONSIBILITIES OF PERSONNEL HANDLING HAZARDOUS DRUGS
- Where does the DESIGNATED PERSON obtain the necessary training for this job?
- How much training is "sufficient" for a DESIGNATED PERSON?
- How much time will be required for the DESIGNATED PERSON to do these activities each week?
- How many "support personnel" will be required to maintain records, etc.?
- How will the "action limits" be set for establishing "risks"?
FACILITIES AND ENGINEERING CONTROLS
- Is it necessary to post a sign at the front door to the store that HDs are in the pharmacy?
- If not, at what point is posting required?
- 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 CSPs and another for nonsterile preparations. Can you tell me where it is?
- 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.?
- 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?
COMPOUNDING
- 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?
- 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?
- 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.
- 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?
- 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?
- 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?
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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