National Drug Code

A registered pharmacy completes the DEA Form 222 in triplicate. The pharmacy submits Copy 1 and Copy 2 to the supplier/ wholesaler and retains Copy 3 in the pharmacy. The supplier completes the order and records on Copy 1 and Copy 2, the number of commercial or bulk containers supplied on each ordered item and the date the containers were shipped to the pharmacy. DEA policy does not preclude the substitution of identical products differing in packaging size from those initially ordered provided the actual quantity does not exceed the amount initially ordered and the National Drug Code (NDC) number reflected is that of the actual product shipped. For example, if the pharmacy ordered 1 bottle of 500, 10 mg tablets, the supplier can send 5 bottles of 10 mg tablets for a total of 500 as was ordered. 

At a minimum, the bar code must contain the drug product s National Drug Code (NDC) number in a linear bar code. The bar coding should be used on drugs down to unit-of-use package size. The lot number and expiration date are not required. The manufacturer may include if they so desire. 

Important protocols for method validation in the literature have been derived, amongst others, from the Current Good Manufacturing Practice, Code of Federal Regulations, Food and Drug Administration, National Drug Administration, the United States Pharmacopoeia Convention, the American Public Health Association and the International Conference on Harmonization. 

CFR868 Anesthesiology Devices, Part 868, Title 21-Food and Drugs, Code of Federal Regulations Office of the Federal Register, U.S. National Archives and Records Administration Washington... 

Drivers who are subject to the commercial driver s license requirements of the Canadian National Safety Code, or the Licencia Federal de Conductor (Mexico) requirements and operate a commercial motor vehicle in the United States are also subject to the alcohol and drug regulations in Part 382. 

The regulations also address the need to ensure that drug information provided by pharmaceutical firms is truthful, balanced, and accurately communicated. As such, it must be consistent with the indications for use and the established performance and limitations. In Europe, the directives do not impose a specific requirement to review advertising or promotional material before it is released. Acceptable standards may be achieved via voluntary codes of practice and self-regulation. However, national authorities must monitor such material and should have the power to act where the need arises. In the U S, the F DA must vet advertising and promotional material before it is released. 

Code of Federal Regulations 21. Food and Drug Administration, Parts 100 to 199. Revised annually. Published by the Office of Federal Register, National Archives and Records Administration. 

Eood and Drug Administration (EDA). Investigational New Drug Application. 21 Code of Federal Regulations Part 312. Washington DC National Archives and Records Administration, 1998. 

Niknla, K.J., Novak, R.F., Chang, I.Y., Dahl, A.R., Kracko, D.A., Zangar, R.C., Kim, S.G. Lewis, J.L. (1995) Indnction of nasal carboxylesterase in F344 rats following inhalation exposure to pyridine. Drug Metab. Dispos., 23, 529-535 NOES (1999) National Occupational Exposure Survey 1981-83. Unpnblished data as of July 1999. Cinciimati, OH, Department of Health and Hnman Services, Public Health Service, Centers for Disease Control, National Institnte for Occnptional Safety and Health Occupational Safety and Health Administration (1999) Air contaminants. US Code. Fed. 

The Director of the National Institutes of Health and the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration shall submit to the Board for inclusion in the annual report a report on the rare disease and condition research activities of the Institutes of the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health Administration the Secretary of the Treasury shall submit to the Board for inclusion in the annual report a report on the use of the credit against tax provided by section 44H of the Internal Revenue Code of 1954 and the Secretary of Health and Human Services shall submit to the Board for inclusion in the annual report a report on the program of assistance under section 5 of the ODA for the development of drugs for rare diseases and conditions. Each annual report shall be submitted by June 1 of each year for the preceding calendar year. 

---