Pharmacy Compounding

Purpose of the USP 800 Guidelines: Hazardous Drug (HD) Handling

The purpose of U.S. Pharmacopeia Convention (USP) 800 is to prevent exposure to known or suspected carcinogens, genotoxins, mutagens, teratogens, compounds that are toxic to organs at low doses, including atineoplastic drugs, which increase the risk of infertility and fetal damage. The Although USP does not enforce its guidelines, your company may adopt compliance depending on specific pharmacy, accreditation, or FDA standards. USP 800 covers cleanroom requirements and how to receive, unpack, handle, prepare, administer, and dispose of sterile and non-sterile HDs related to pharmacy compounding. The protocols are stringent and encompassing to safeguard the health of essential pharmaceutical compounding employees as well as to guarantee the highest quality of life-saving therapies for beneficiaries in need.

A Coordinated Effort

Best practices are achieved when teams are committed and well-trained. Therefore, a competent and knowledgeable Compounding Supervisor is assigned to oversee and monitor the compounding facility, as well as ensure that appropriate testing is maintained and reported. While all workers have continued training, the compounding supervisor is proficient in all aspects of HD handling from cradle to grave.

Risk Prevention

The facility must have a register of any HD or atineoplastic drug that is used on the NIOSH list. In addition, the lab needs to develop containment strategies or a risk assessment that is reviewed every 12 months. The risk assessment covers potential exposure activities such as dosage form, packaging, compounding, and administration for each HD to protect workers and patients. Spill prevention, work area wipe testing at 6-month intervals, and medical surveillance programs are also outlined in USP 800.

HD Handling & Engineering Controls

HD handling areas, such as unpacking, storage, and compounding (sterile and non-sterile), must be clearly marked with hazard specifics.  

• Unpack HDs in designated neutral/negative pressure room to prevent contamination of sterile compounding room or non-pharmacy area. Wear PPE, including chemotherapy gloves, to remove HDs from original containers and immediately transfer to HD storage.
• Store HDs separately, with the exception of non-antineoplastic HDs, reproductive risk only, and antineoplastic final dosage forms. Hazardous and antineoplastic drugs for compounding are to be stored in separate, negative pressure rooms with ≥ 12 air changes per hour (ACPH) – this includes refrigerated storage. Only store sterile HDs in areas for sterile compounding and not with non-sterile HDs.
• Compound HDs in designated area of secondary engineering control (C-SEC). For lower hazard drugs with up to 12-hr beyond-use-date (BUD), a containment segregated compounding area (C-SCA) may be considered. See Lab Pro’s USP 800 Cheat Sheet for details and definitions.
• Non-sterile: Vent externally or use redundant HEPA filtered, 12 ACPH, negative pressure conditions
• Sterile: ISO Class 7 buffer room & anteroom, vent externally, 30 ACPH, negative pressure
• C-SCA: Vent externally, 12 ACPH, negative pressure

PPE

Although USP 800 outlines PPE use, facility-specific SOPs may be necessary if they are not addressed in the document. Lap Pro offers an assortment of cleanroom PPE.

• Wear gloves, gowns, head/hair coverings, beard covers, shoe covers for sterile or non-sterile compounding.
• Depending on hazard level, eye and face protection and respiratory protection may also be required to protect workers from HDs.
• Handle HDs with ASTM D6978 gloves.
• When administering antineoplastic drugs, use two pairs of gloves.
• Wear double gloves and HD resistant gowns for injectable HD/chemotherapy
• When entering HD C-SEC, wear two pairs of shoe covers. Remove them when you leave the room.

Cleaning Procedures

Deactivate, decontaminate, and clean surfaces and devices where HD are used. Follow with disinfection for sterile compounding.

1. Deactivate compounds with EPA-registered oxidizers such as peroxide solutions or sodium hypochlorite (must be neutralized to prevent corrosion on stainless steel).
2. Decontaminate HD residues with validated methods. Could include IPA, DI water, peroxide, sodium hypochlorite per test results. Wipe residue away, rather than spray. For Compounding Aseptic Containment Isolator (C-PEC), decontaminate
   • Daily, when used or spills occur, or between different HDs
   • If interruption occur or ventilation tool is disturbed
   • Monthly, under tray
   • Before and after certification
3. Clean organic/inorganic residues with germicidal detergent.
4. Disinfect with sterile IPA or EPA-registered disinfectant.

Lab Pro offers several products for your USP 800 obligations:

• Ready-to-use Sporicidin Sterilizer is a USP/EPA/OSHA compliant, non-corrosive cleaner and disinfectant for hard surfaces and floors in ISO Class 8 Anterooms.
• 70%IPA , USP grade sterile water, as well as hydrogen peroxide and sodium hypochlorite

USP 800 Training and Compliance 

Delivering tailored compounded pharmaceuticals to patients requires the best in class of technical knowledge, raw materials, personnel, and protocol for every preparation. Here are a list of companies that offer excellent training to get you and your staff complaint:

• PCCA: PCCA provides pharmacists, pharmacy techs, and pharmacy owners with the resources, continuing education (ce), and tools. 
• ACA: The American College of Apothecaries 

Note: These chemicals are meant to be used for research, industrial work, cleaning or disinfecting and should always be stored out of the reach of young children or infants. 

For over 40 years, Lab Pro Inc. has been committed to delivering the highest quality chemicals, reagents, and cleaning solutions to medical and biotechnical laboratories in  California and worldwide. To learn more, visit the biggest Lab Supply showroom in California, or contact us online or at 888-452-2776.