Pharmaceutical Consulting Services in Phillips Ranch California is one such company. It has announced it will begin operations by the end of June and anticipates GMP-related business.

"We have been in the planning stages of building this company for well over a year," said Elizabeth Balsz, public relations and customer service manager for Pharmaceutical Consulting Services. "It just seems that the time is right with the final ruling on GMPs for dietary supplements appearing to be imminent."

The countdown to preparations became imminent in May, when Senator Hatch received word from the White House Office of Management and Budget that the legislation would likely be published some time in June.

A statute of the 1994 Dietary Supplements Health and Education Act (DSHEA), GMP legislation has been referred to as the missing link in the overall governance of the dietary supplement industry.

The legislation will provide standards specific to this industry for inspectors to check for purity, safety and legality in manufacturing.

These standards will in turn create new business opportunities for companies or organizations that can support manufacturers looking to upgrade or comply with GMPs within the time frame to be specified. The deadline for compliance is predicted to the end of this year.

Pharmaceutical Consulting Services says it will be able to consult on regulatory compliance issues and will draw on associates from all levels and areas within the dietary supplement industry. Its senior associates each claim over 30 years' experience.

The uncertainty surrounding the soon-to-arrive documents has companies and trade associations alike wondering what they will be faced with.

The GMPs will initially be released online as part of the US Food & Drug Administration's Federal Register. The document has been completely confidential and the exact date of release is not publicly known, but it is expected to be approximately 1300 pages in length.