Drug Manufacturing and Distribution

This page contains information regarding regulation of drug manufacturing and distribution by the Food and Drug Unit. If you wish to operate a drug-manufacturing facility in the state of Louisiana, you must obtain a Permit to Operate and a Certificate of Registration from the FDU. In addition, you must register your firm with the federal Food and Drug Administration and obtain pre-market approval for any new drug products you will be producing. If you will be making any controlled dangerous substances, as defined by the federal Comprehensive Drug Abuse Prevention and Control Act of 1970, your firm will also need to register with the Drug Enforcement Administration of the U.S. Department of Justice.

State regulations for drug manufacturing can be found in Chapter 15 of Part VI of Title 51 of the Louisiana Administrative Code. The language therein closely mirrors the federal current Good Manufacturing Practices documented in 21 CFR 211 et seq. Chapter 17 contains regulations pertaining to drug storage and distribution.

Manufacturers

The procedure for obtaining a Permit to Operate for your facility is similar to that for a food-manufacturing operation. You should first ascertain where your facility will be located and provide the relevant sanitarian with plans and specifications for the facility, a plans review questionnaire, and a parish utility letter. The contact information is available here. Prior to registration of products from a new manufacturing facility, we will also need documentation verifying that the products have been approved by FDA and prior to issuance of a Permit to Operate, we will need confirmation that your facility has been inspected by FDA. Once the plans are approved, the sanitarian will notify you by letter and you may make arrangements for an initial inspection. If any defects are noted at the time of inspection, a reinspection may be required; otherwise, the sanitarian will document his/her findings on the appropriate form and issue a temporary permit.

Warehouses, Brokers & Distributors

The procedure for obtaining a Permit to Operate for your facility is similar to that for a food storage warehouse. You should first ascertain where your facility will be located and provide the relevant sanitarian with plans and specifications for the facility, a plans review questionnaire, and a parish utility letter. The contact information is available here. Once the plans are approved, the sanitarian will notify you by letter and you may make arrangements for an initial inspection. If any defects are noted at the time of inspection, a reinspection may be required; otherwise, the sanitarian will document his/her findings on the appropriate form and issue a temporary permit.

Note that if you are distributing drugs or medical devices on a wholesale basis, you may need to register your business with the Louisiana State Board of Wholesale Drug Distributors. If your proposed business is a retail pharmacy, however, you will need to obtain a license from the Louisiana State Board of Pharmacy. Links to these entities are provided on our Links page. 

Medical Gasses

Medical gasses are gasses used for medicinal purposes and are classified as drugs by FDA. Medical gasses include breathing air, oxygen, nitrogen, carbon dioxide, helium, nitrous oxide, and cyclopropane. Medical gasses are only available to consumers by prescription.

New medical gas production or storage and distribution facilities operating within the state of Louisiana must hold a Permit to Operate from the Food and Drug Unit. Such facilities may also be regulated by the Louisiana State Board of Drug and Device Distributors. Additionally, all manufacturing facilities must be registered with the federal Food and Drug Administration.

Note that durable medical equipment (DME) providers that distribute medical gasses are required to hold a medical gas warehouse permit, while those conducting transfilling operations must have a manufacturer's permit. Any facilities using air separation units (ASU) are required to be permitted as manufacturers.

To obtain a medical gas manufacturer's permit, you must submit the plans for your facility, along with a plans review questionnaire and a parish utility letter, to the district sanitarian who covers the area where your facility will be sited. For a list of these areas, go to our contacts page. After the plans have been reviewed, the sanitarian will send a plans approval or disapproval letter. If you receive a disapproval letter, respond with the necessary corrections or amendments. If you receive an approval letter, you should contact the sanitarian to arrange for a pre-operational inspection, at which time you will need to be prepared to review all paperwork and procedures, as well as conduct a walkthrough and be prepared to show that the facility or relevant personnel have obtained all necessary licenses (except the Permit to Operate, of course).

Additionally, if your facility packages in cylinders in addition to or in lieu of bulk tankers or rail cars with a label bearing your firm's name, your cylinders will need to be registered with our office. Send a copy of the label or label artwork to the Product Registration Program Manager, currently Brian R. Warren. He or she will review the label for compliance with relevant regulatory requirements and if any changes need to be made, will notify you of such. When the label has been accepted for registration, you will need to send a copy along with a list of products, completed registration application, and registration fee (check or money order payable to DHH) to the Central Office for processing.

To obtain a medical gas distributor's permit, you must submit the plans for your facility, along with a plans review questionnaire and a parish utility letter, to the district sanitarian who covers the area where your facility will be sited. For a list of these areas, go to our contacts page. After the plans have been reviewed, the sanitarian will send a plans approval or disapproval letter. If you receive a disapproval letter, respond with the necessary corrections or amendments. If you receive an approval letter, you should contact the sanitarian to arrange for a pre-operational inspection, at which time you will need to be prepared to review all paperwork and procedures, as well as conduct a walkthrough and be prepared to show that the facility or relevant personnel have obtained all necessary licenses (except the Permit to Operate, of course). 

Resources

• FDU Drug Manufacturing Regulations
• FDU Drug Warehousing Regulations
• Plans Review Packet - a packet can be downloaded here under "Plans Packet for Drug Manufacturers" or "Plans Packet for Drug Warehouses"

Contact

For more info, contact the Food & Drug Program at 225-342-7533.