(Learning about USP Chapter <800> in 10 minutes a week.)

7.5 Respiratory Protection

• Personnel unpacking HDs not contained in plastic should wear an elastomeric half-mask with multi-gas cartridge and P100-filter until packaging integrity is confirmed.
• A surgical N95 respirator provides respiratory protection and provides a barrier to splashes, droplets, and sprays around the nose and mouth.
• A fit-tested NIOSH-certified N95 or more protective respirator is adequate against airborne particles�.BUT offer no protection against gases and vapors with little protection against direct liquid splashes.
• Workers need to be "fit-tested" and "trained" on the use of the respirators.
• An appropriate full-facepiece, chemical cartridge-type respirator or powered air-purifying respirator (PAPR) should be worn when there is a risk of respiratory exposure to HDs, including when:
  • Attending to HD spills larger than what can be contained with a spill kit.
  • Deactivating, decontaminating, and cleaning underneath the work surface of a C-PEC.
  • There is a known or suspected airborne exposure to powders or vapors.

7.6 Disposal of Used Personal Protective Equipment

• Consider all PPE worn when handling HDs to be contaminated.
• PPE must be placed in an appropriate waste container and disposed of as per local, state, and federal regulations.
• PPE worn during compounding should be disposed of properly before leaving the C-SEC.
• Chemotherapy gloves and sleeve covers must be carefully removed and discarded immediately:
  • into a waste container approved for trace contaminated waste inside the C-PEC or
  • contained in a sealable bag for discarding outside the C-PEC.

QUESTIONS

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.

Note: For a full list of questions for which we are awaiting answers from USP, please go to: http://www.ijpc.com/USP800Questions

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

NOTE: Additional SOPs related to "Deactivating, Cleaning and Disinfecting BSCs" have been added to www.CompoundingToday.com in the area of Hazardous Drugs compounding.

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Did You Know ...

�that the Drug Quality and Security Act,", H.R. 3204, DQSA, refers to the USP as follows?:

(2) BULK DRUG SUBSTANCES-The drug is compounded in an outsourcing facility that does not compound using bulk drug substances (as defined in section 207.3(a)(4) of title 21, Code of Federal Regulations (or any successor regulation)), unless-

(B) if an applicable monograph exists under the United States Pharmacopeia, the National Formulary, or another compendium or pharmacopeia recognized by the Secretary for purposes of this paragraph, the bulk drug substances each comply with the monograph;

(D) (3) Ingredients (Other than bulk drug substances)-If any ingredients (other than bulk drug substances) are used in compounding the drug, such ingredients comply with the standards of the applicable United States Pharmacopeia or National Formulary monograph, if such monograph exists, or of another compendium or pharmacopeia recognized by the Secretary for purpose of this paragraph if any.

Tip of the Week

Similar to last week's discussion, both FDAMA97 and the DQSA refer to the USP-NF as it relates to the quality of "ingredients" used in compounding. So far we know that:

1. USP standards must be science-based.
2. USP General Chapters are to centralize testing information relevant to several substance and product monographs.
3. The USP is recognized as official because of its standards for substances (ingredients) and products/preparations.
4. FDAMA97 recognizes the USP standards for ingredients to be used in compounding.
5. DQSA recognizes the USP standards for ingredients to be used in compounding.
6. There is nothing in the 1906 Act, FDAMA97 or DQSA concerning practice standards for pharmacy, medicine, nursing, etc.

Looking Back

Don't pass cars,
On curve or hill,
If the cops don't get you,
The morticians will!
     Burma Shave