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SCSafety City CompliancePermit, fire & medical-gas compliance
Medical oxygen program

Your squad is a drug manufacturer now. Most squads still don't know.

FDA's medical-gas rule, 21 CFR Part 213, took effect December 18, 2025. If you fill your own oxygen cylinders, your fill records, purity tests, and training file now have to meet pharmaceutical-grade rules. It is a paperwork problem, and it is fixable this month.

OXYGEN CYLINDER RECORD
SerialAL-4471820
DOT spec3AL 2015
Last requal03/2022
Next requal03/2027
Fill lotSCC-0912-07
Purity (USP)99.6%
Odor testPASS
RIG READY
What gets checked

When someone finally looks, this is the list

FDA21 CFR Part 213

Cylinder fill lot logs, purity testing, labeling, training records, a designated quality unit, and written procedures for every step.

DOT49 CFR 180.209

Every oxygen cylinder is on a requalification clock: five or ten years depending on specification and stamp. Out-of-date cylinders cannot legally be filled or transported.

State EMSAgency inspections

Licensed-agency inspections check oxygen readiness on the rig and the documentation behind it.

State HealthN.J.A.C. 8:21-3A

Anyone distributing medical oxygen wholesale needs a state wholesale drug distributor license, and the facility's supplier must hold one.

For EMS squads and fire departments

The squad compliance retainer

One flat monthly retainer, written on the price sheet you get at the free station gap review. The squad keeps running calls; we keep the file inspection-ready.

IncludedWhat you get
Fill-station documentation programPart 213 SOPs, quality-unit designation, lot logs, purity and odor records, training file, complaint and recall procedure
Cylinder trackingEvery O2 cylinder by serial, DOT spec, and requalification date, with out-of-date units flagged before they go on a rig
Rig and station extinguishersInspected, tagged, current (on permit issuance; documented and coordinated today)
AED programPads, batteries, and training records managed before they expire
SCBA and breathing air (fire departments)Hydro cycles tracked, NFPA 1989 quarterly sampling calendar and lab records filed
Annual station auditWe walk it before an inspector does, with a written gap list
TermsFlat monthly retainer from the written price sheet · 12-month term that does not auto-renew · cancel with 30 days' notice · records belong to the agency

"I run calls in this county. I know what a Saturday night looks like, and I know nobody volunteers to do lot-log paperwork. That is exactly why I built this."

Founder, Safety City Compliance · NJ EMT

For hospitals and nursing homes

Oxygen supply compliance for the facilities that use the most of it

Every cylinder that enters a healthcare facility is a prescription drug in a DOT-regulated container, stored under NFPA 99 rules the fire official checks and dispensed under pharmacy rules the surveyor checks. We document the whole chain so both surveys close clean.

Cylinder receiving & lot documentation

Supplier license on file, delivery lot numbers logged, certificate of analysis retained, and every cylinder matched to a serial and requalification date at receipt.

Storage & signage under NFPA 99

Full and empty segregation, quantity limits per smoke compartment, securing, signage, and the storage-room requirements surveyors cite most often, walked and photographed on a schedule.

Bulk system & manifold records

Vendor inspection reports for bulk oxygen and manifold systems reviewed for open items, filed with the Environment of Care documentation, and tracked to the next due date.

Emergency supply readiness

Emergency oxygen supply connection tested and documented, reserve quantities verified, and the plan the Life Safety surveyor asks to see.

Quarterly LHU Type C prep

Type C occupancies are inspected four times a year. We pre-walk each one with a written checklist so the bureau's visit confirms what your file already shows.

One file for three surveys

Fire prevention bureau, CMS Life Safety, and the pharmacy survey read the same site file, organized the way each of them reads it.

Supply, honestly labeled

Where supply stands today, and where it is going

Available now: the documentation and cylinder-tracking program above, and coordination with your existing filler or distributor so deliveries, lots, and requalification dates land in your file.

On the roadmap: medical oxygen cylinder exchange and, later, filling under our own FDA establishment registration, 21 CFR Part 213 quality system, DOT requalifier registration, and New Jersey wholesale drug distributor license. Each line is announced only when its registration issues. We will never sell you a cylinder we are not licensed to fill.

See the full licensing roadmap →

Free station gap review

Thirty minutes at your station or facility. We show you in writing exactly where your records stand against Part 213, the DOT cylinder rules, and NFPA 99. Want to fix it yourself with that list? Do it. The list is yours either way.