16.2 Hazardous Drugs (USP <800>, NIOSH)
Key Takeaways
- USP <800> Hazardous Drugs—Handling in Healthcare Settings covers receipt, storage, compounding, dispensing, administration, and disposal of drugs on the current NIOSH hazardous-drug list (2024 list, DHHS/NIOSH Publication 2025-103, two tables).
- Antineoplastic HDs that require manipulation beyond counting or repackaging, and HD APIs, must be stored separately from non-HDs in an externally ventilated negative-pressure room with at least 12 air changes per hour; an assessment of risk cannot waive those storage rules.
- HD compounding uses a containment primary engineering control (C-PEC: Class II BSC, CACI, or CVE) inside a containment secondary engineering control (C-SEC: ISO Class 7 buffer with ISO Class 7 anteroom, or an unclassified C-SCA). Technique and BUDs are Chapter 17.
- RCSA § 20-576-66 requires sterile compounding pharmacies to follow current USP <797>; RCSA § 20-576-71 requires nonsterile compounding pharmacies to follow current USP <795>. Those current chapters send hazardous-drug handling to <800>. §§ 20-576-64 and 20-576-69 are definition sections, not a verbatim reprint of <800>.
- Each entity maintains its own HD inventory from the NIOSH list and reviews it at least every 12 months. Receipt of antineoplastic HDs and HD APIs occurs in a negative- or neutral-pressure area, not in a positive-pressure or sterile compounding room.
16.2 Hazardous Drugs (USP <800>, NIOSH)
Quick Answer: USP <800> is Hazardous Drugs—Handling in Healthcare Settings. It uses the current NIOSH list of hazardous drugs (2024 list, DHHS (NIOSH) Publication 2025-103, reorganized into two tables). Antineoplastic HDs that require manipulation (more than counting or repackaging intact final dosage forms) and HD APIs are stored separately from non-HDs in an externally ventilated negative-pressure room with at least 12 ACPH. C-PEC (Class II BSC, CACI, or CVE) sits inside a C-SEC. RCSA § 20-576-66 incorporates current USP <797>; § 20-576-71 incorporates current USP <795>. Those current chapters send HD handling to <800>. Compounding technique is Chapter 17.
NABP Competency 4.2.3 is hazardous-drug storage and handling, not the full sterile-compounding BUD table. A candidate who recites CII-safe rules for cyclophosphamide powder has grabbed the wrong chapter.
What counts as a hazardous drug
USP <800> does not invent its own drug list. It starts from NIOSH. NIOSH treats a drug as hazardous if it shows at least one of: carcinogenicity; teratogenicity or other developmental toxicity; reproductive toxicity in humans; organ toxicity at low doses; genotoxicity; or it is a new drug that mimics an existing HD in structure or toxicity.
The 2024 NIOSH List of Hazardous Drugs in Healthcare Settings (Publication 2025-103, posted December 2024) supersedes the 2016 three-table list. The 2024 list uses two tables:
- Table 1 — drugs with manufacturer’s special handling information (MSHI) in the package insert, and/or drugs that meet the NIOSH definition and are NTP “known to be a human carcinogen” or IARC Group 1 or 2A.
- Table 2 — drugs that meet the NIOSH definition without those MSHI / NTP / IARC placements.
NIOSH added drugs after publication when new labels carried MSHI (for example July 17, 2025 additions to Table 1). The exam fact is the current NIOSH list, not a 2016 three-group flashcard. USP and NIOSH held a joint webinar on the 2024 list in January 2025; entities still must build their own HD inventory from that list plus any drug that meets the NIOSH definition even if it has not yet appeared on a table.
Each entity reviews its HD list at least every 12 months and screens each new drug or dosage form on receipt. If the entity does not perform an assessment of risk, it handles every HD with all of <800>’s containment strategies.
An assessment of risk is not a waiver factory. It is available for some intact final dosage forms (counting, repackaging) and for some non-antineoplastic HDs. It does not let the pharmacy skip negative-pressure storage, C-PEC compounding, or full PPE for HD APIs or for Table 1 antineoplastics that must be manipulated (crushed, split, compounded, opened).
Receipt and storage — before anyone compounds
Receipt is an <800> activity. Antineoplastic HDs and HD APIs are unpacked in an area that is negative or neutral pressure, not in a positive-pressure space and not in a sterile compounding area. Staff wear PPE appropriate to the risk (at least chemotherapy gloves for suspected contamination), have a spill kit, and visually check for damage. A crushed chemo carton on the ordinary receiving bench in a positive-pressure stockroom is an <800> miss before any C-PEC is turned on.
Storage is the 4.2.3 item:
| HD category | Where it may live | Engineering note |
|---|---|---|
| HD APIs and antineoplastic HDs requiring manipulation | Separate from non-HD inventory | Externally ventilated negative-pressure room, ≥ 12 ACPH |
| Refrigerated Table 1 antineoplastic HDs | Dedicated refrigerator in a negative-pressure area with ≥ 12 ACPH (storage room, HD buffer, or C-SCA) | Not the anteroom household refrigerator |
| Non-antineoplastic HDs, reproductive-risk-only HDs, and final dosage forms of antineoplastic HDs | May be stored with other inventory if entity policy and any assessment of risk allow it | Still prevent breakage, spillage, and mix-ups |
| Sterile and nonsterile HDs | May be stored together under <800> | Nonsterile HDs do not belong in the sterile HD buffer if they would contaminate sterile compounding |
Do not store HD inventory so that a broken vial contaminates non-HD fast movers. Do not put the chemo refrigerator in a positive-pressure anteroom “because that is where the old fridge lived.”
PPE and engineering controls — teaser only
<800> exists to contain. Two engineering-control nouns appear on MPJE stems:
- C-PEC (containment primary engineering control) — the ventilated device in which compounding happens: a Class II biological safety cabinet (BSC), a compounding aseptic containment isolator (CACI), or, for nonsterile work, a containment ventilated enclosure (CVE) / powder hood. Sterile HD compounding needs a C-PEC that delivers ISO Class 5 or better air (typically Class II BSC or CACI), externally vented. Nonsterile weighing and mixing use a C-PEC that is externally vented (preferred) or has redundant HEPA filters in series.
- C-SEC (containment secondary engineering control) — the room that houses the C-PEC. Preferred: ISO Class 7 HD buffer room with an ISO Class 7 anteroom. Alternative: unclassified containment segregated compounding area (C-SCA). The C-SEC is negative pressure relative to adjacent areas, with ≥ 12 ACPH (buffer) — C-SCA airflow and BUD limits are Chapter 17.
PPE for HD compounding is not a cloth lab coat: ASTM D6978 chemotherapy gloves (two pairs when compounding), a polyethylene-coated disposable gown that closes in the back, eye and face protection when splashes are possible, and a respirator when work is not fully contained in a C-PEC. Glove- and gown-change intervals, the four-step HD surface cleaning sequence, and sterile HD BUDs belong in Chapter 17. This section only needs you to refuse an open-bench chemo reconstitution.
Does Connecticut incorporate USP <800>?
Be precise. RCSA § 20-576-64 is the sterile compounding definitions section (what a “sterile compounding pharmacy” is — a § 20-594 pharmacy that dispenses sterile products, not including a pharmacy that is part of a licensed hospital). RCSA § 20-576-69 is the nonsterile compounding definitions section. Neither paragraph reprints <800>.
The incorporation sits one section later:
- RCSA § 20-576-66(b): a sterile compounding pharmacy shall comply with §§ 20-576-64 through 20-576-68 and the current United States Pharmacopeia, Revised General Chapter 797.
- RCSA § 20-576-71(b): a non-sterile compounding pharmacy shall comply with §§ 20-576-69 through 20-576-73 and the current USP <795>.
Current <797> and <795> (official November 1, 2023) send hazardous-drug compounding and handling to USP <800>. DCP’s sterile compounding inspection form already tells inspectors to see <800> for pressure requirements when the site compounds HD CSPs. So Connecticut does not have a lone “we adopt USP 800” sentence inside 20-576-64 or 20-576-69, but a Connecticut sterile or nonsterile compounding pharmacy that follows current 797/795 as those regulations require is in <800> for HD work. Hospital pharmacies are outside the 20-576-64 definition of “sterile compounding pharmacy”; they still face <800> as the national HD standard and as the document DCP uses when inspecting HD pressure relationships.
Realistic Connecticut scenario
A Waterbury specialty pharmacy starts compounding methotrexate oral suspension from API. Staff unpack the API on the ordinary positive-pressure receiving bench, park the bottle next to amoxicillin powder, and plan to mix it in a horizontal laminar-flow hood “because we already have 797.” That chain fails <800> at receipt, storage, and C-PEC selection. The API needed negative- or neutral-pressure unpacking, separate negative-pressure ≥12 ACPH storage, and a containment PEC (not a non-containment horizontal hood that blows HD toward the operator). RCSA § 20-576-71 already required current <795>, which points HD compounding to <800>. Counting manufacturer methotrexate tablets for a labeled prescription, without crushing, is a different, narrower path that an assessment of risk and entity policy may keep on ordinary stock — it is not a license to treat the API like a vitamin.
CT may be stricter; more-restrictive wins. Compounding technique, category BUDs, and full PPE change-out times are Chapter 17.
Official anchors
- USP <800> overview — Hazardous Drugs—Handling in Healthcare Settings.
- NIOSH List of Hazardous Drugs, 2024 (Pub. 2025-103) — two-table list that supersedes 2016-161.
- RCSA § 20-576-66 — sterile compounding pharmacy must follow current USP <797>.
- RCSA § 20-576-71 — nonsterile compounding pharmacy must follow current USP <795>.
- DCP sterile compounding inspection form — cites USP <800> for HD CSP pressure requirements.
A Connecticut pharmacy stocks cyclophosphamide powder (an HD API) and manufacturer cyclophosphamide tablets. Which storage statement matches USP <800> as applied through the current NIOSH list?
Do Connecticut compounding regulations point a community pharmacy to USP hazardous-drug standards?
A Stamford hospital pharmacy will start compounding sterile hazardous drugs. Which description of the engineering controls is correct, and where is compounding technique taught?