Requirements For Holding And Distributing Medical Gas Products

Medical gas firms that distribute gases bearing the “USP” or “NF” label are handling a pharmaceutical drug product and are required to comply with the Current Good Manufacturing Practices (cGMPs) for the holding and distribution of drugs. These requirements, found in 21 CFR _211.142, 211.150 and 211.196, establish the compliance requirements for medical gas firms and are the law. This article will examine how these FDA regulations apply to the unique aspects of medical gases.

These cGMP requirements apply to your medical gas manufacturing/cylinder fill sites, as well as your locations that only distribute cylinders filled at another facility, including third-party suppliers. Medical gas firms need to ensure that FDA requirements are met for all medical gases sold or distributed from a location, not just those cylinders that were filled on site.

Warehousing Procedures (§211.142)
FDA requirements for warehousing of medical gases have two key provisions that must be addressed in your SOPs:

  1. Storage, quarantine and designation of medical gas cylinders during processing and prior to release for distribution (by the QCU)
  2. Storage of drug products under appropriate conditions of temperature, humidity and light so that the identity, strength, quality and purity of the drug products are not affected.

To meet these requirements we recommend medical gas firms designate separate areas for the following activities to ensure effective cylinder management:

  • Empty containers
  • Full containers
  • In-process containers
  • Rejected containers
  • Different types of medical gases
  • Medical gases that have been released
  • Medical gases that have not been released.

We further recommend that medical gas firms ensure medical gases are stored separately from industrial gases, and that storage areas be clean, dry, well ventilated, free of combustible materials and protected from contamination such as insect, rodent or bird infestation.

Distribution Procedures (§211.150)
FDA regulations require firms to develop and follow written procedures describing the distribution of medical gases. These requirements specify that medical gas stocks are rotated so that the oldest batch is distributed first (FIFO). FDA also requires firms to establish a system to track the distribution of each lot of drug product, to facilitate its recall if necessary.

Firms should have inventory control procedures that ensure the oldest approved stock of a drug product is distributed first (FIFO). Deviation from this requirement is permitted only if such deviation is temporary and appropriate (i.e., distribution of customer-owned cylinders). Firms also should have recall procedures in place that detail:

  • Who would evaluate distribution information if a recall became necessary
  • How the recall would be initiated
  • Who would be informed about the recall
  • What would be done with the recalled product.

Distribution Records (§211.196)
FDA regulations stipulate that distribution records must contain a minimum of the following information:

  • Name and strength of product
  • Description of dosage form
  • Name and address of consignee (note: consignee address may be by reference, i.e., customer number)
  • Date and quantity shipped.

While medical gas distribution records are not required to contain lot or control numbers, the requirements of §211.150 still must be met. Many medical gas firms do put lot numbers on their shipping papers, as this is the quickest and easiest way to meet the regulations. We recommend firms incorporate into their SOP manual the ability to demonstrate accountability of distributed product, such as performing documented periodic mock recalls to demonstrate their system works effectively.

During audits we frequently find that firms have failed to establish and follow procedures that assure all medical gases are handled, segregated, stored and distributed in accordance with all applicable regulations.

Gases and Welding Distributors Association
Meet the Author
GAWDA Medical Gases Consultant J. Robert Yeoman is managing director of B&R Compliance Associates LLC in Lehigh Valley, Pennsylvania. Members can reach him at 610-837-6782 and at bob.yeoman@brcompliance.com.