Collection of untreated medical waste intended for transport off-site shall be packaged and maintained in the following manner:

1. (1) The outermost layer of packaging for medical waste shall be packaged in containers which have either a red background color or utilize red lettering with contrasting background color and conspicuously labeled with either the words "Infectious" or "Medical Waste" or "Biohazardous" and/or contain the International Biological Hazard Symbol.
2. (a) The wording shall be either printed on the container or securely attached by label on two or more sides. The wording on the label and the International Biological Hazard Symbol must be easily readable and in good condition. The wording and symbol, if utilized, must be in a contrasting color to the background color.
3. (2) Containers shall be impermeable to moisture and shall be of sufficient strength to prevent ripping, tearing, or bursting under normal conditions of use.
4. (3) Sharps shall be placed directly into leak proof, spill proof, rigid, puncture-resistant containers and sealed to prevent loss of contents under normal handling procedures. These containers shall be clearly labeled as described in 335-17-3-.01(1), unless placed in rigid shipping containers that meet this requirement.
5. (4) Small containers used to collect untreated medical waste should be placed inside larger containers to better facilitate storage, transportation, or disposal. Small containers that will be placed into larger shipping containers shall meet the following requirements:
6. (a) Containers used for sharps shall meet the requirements in 335-17-3-.01(3).
7. (b) All other containers shall utilize either a red background color or red lettering or Symbol which contrast with adjacent colors.
8. (c) Wording and the use of the International Biological Hazard Symbol shall be utilized in accordance with 335-17-3-.01(1).
9. (5) The outermost layer of packaging must be properly identified with the following information. This information shall be securely attached or permanently printed and shall be clearly legible.
10. (a) The name and address;
11. (b) The date the waste was packaged in its outermost container;
12. (c) One of the following words or phrases used in conjunction with the International Biological Hazard Symbol: "Medical Waste" or "Biohazardous" or "Infectious."
13. (6) Containers of medical waste must remain intact without signs of leakage or spillage until treatment.
14. (7) Containers of medical waste shall be handled in a manner that does not affect the integrity of the packaging.
15. (8) Disposable single use containers used for the storage and transportation of untreated medical waste shall be rigid, leak resistant, spill resistant, puncture resistant, burst resistant, and tear resistant under normal conditions of handling and use. Reusable containers shall meet the preceding requirements in addition to being constructed of smooth, easily cleanable, impermeable materials and resistant to corrosion. If a fiberboard container is used, it shall meet the standards of 49 CFR §173.197 of the Code of Federal Regulations. All containers must be sealed prior to shipment.
16. (9) Containers utilized for collection, storage and transportation shall be constructed of materials that are compatible with the treatment method to be utilized.
17. (a) Single-use containers destined for incinerators shall be burnable.
18. (b) Containers destined for steam sterilizers shall allow the waste to be treated at required temperature and pressure.
19. (c) Reusable containers shall be decontaminated after each use with an approved treatment method.
20. (d) Reusable containers shall not be used for other purposes unless the following conditions are met:
21. 1. Containers shall be decontaminated by a method approved by the Department;
22. 2. All labeling, symbols or other identifications normally used to identify medical waste shall be removed.

Author: James L. Bryant, Ashley S. Powell

Statutory Authority: Code of Ala. 1975, §§22-27-9, 22-27-12.

History: New Rule: Filed December 12, 2011; effective January 16, 2012. Amended: Published December 31, 2024; effective February 14, 2025. Amended: Published June 30, 2025; effective August 14, 2025.