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Source: OregonLive.com

Date: 17-May-2007

Author: Andy Dworkin

Oregon regulators are drafting new, stricter rules for compounding pharmacies, likely to include the state's first standards for custom-making the pills and lotions that comprise most of the drug compounding business.

Pharmacy experts started working on the new rules two years ago but paused to focus instead on regulating drug wholesalers and Canadian imports. Early this year, they shifted back to the compounding code, trying to incorporate two national standards for how to safely mix individual drug batches that many other states have already adopted.

Following the national standards won't guarantee made-to-order drugs are safe. States with similar standards include Texas, where the compounding pharmacy ApotheCure made a weighing error that led to a batch of the drug colchicine 10 times too strong. That batch has been linked to the deaths of two Oregonians and a Washington resident, and federal and state regulators are investigating the pharmacy error.

But the new standards are pushed by national pharmacy groups who think adoption by all 50 states will make ready-made drugs generally cleaner and more reliable -- and quiet calls for more federal regulation of the business.

"It puts stricter standards on compounding and helps to identify what compounding is, as opposed to manufacturing . . . to make sure it's safe, so federal agencies don't have to come in and regulate it more," said Gary Schnabel, executive director of the Oregon Board of Pharmacy.

At least 20 states have adopted one or both of the two standards Oregon is considering.

"We're not far behind," Schnabel said. "But we're not right up front, either."

The draft of the new rules will probably go to the state pharmacy board for review this summer and be approved by December, he said.

States now regulate pharmacies, including drug compounding, which involves making small batches for one patient or one doctor. Some critics say compounders such as ApotheCure -- which serves more than 12,000 doctors worldwide -- are really acting like mass-market drug manufacturers, such as Eli Lilly, which are regulated by the U.S. Food and Drug Administration.

Setting standards for the processes used to compound drugs is vital, because there's no practical way for pharmacists to test each batch of drugs they have mixed. The only way to be sure the medicine is always made right is to be sure all the steps involved in compounding the drug are safe and accurate.

Fatal failures in the compounding process spurred the recent drive for similar, stricter drug codes throughout the United States.

In 2001, for instance, three people died in California after injections of a steroid that was contaminated with bacteria at a compounding pharmacy that didn't properly sterilize equipment or drug vials. Most notorious was Kansas City, Mo., compounding pharmacist Robert Courtney, who is serving 30 years in prison after diluting cancer medicine and other drugs meant for thousands of patients, although that case was not an error but malice for profit.

Such problems "tar the reputation of every member of the profession" and made compounders nationwide cringe, according to the main pharmacy standard-setting group, U.S. Pharmacopeia.

Growth in the size and number of compounding pharmacies since the 1990s also fed the drive for new standards, said Ken Baker, executive director of the Pharmacy Compounding Accreditation Board. Pharmacy groups united in 2004 to create that board, which offers a "seal of approval" to compounders who meet strict but voluntary standards.

State regulators and pharmacy trade groups have mainly focused on getting states to adopt the two U.S. Pharmacopeia standards Oregon is weighing, said Joshua Wenderoff, spokesman for the International Academy of Compounding Pharmacists. One of those (USP 795) deals with "nonsterile" medicines: pills, creams and other non-injected drugs that are the main products of compounders. The other standard (USP 797) covers injected or "sterile" medicines, which are less common but far trickier to make, because they must be pure to avoid infections.

Both standards seem stricter and more detailed than Oregon's current rules. The state's code for injectable compounded drugs now runs about 21/2 pages, for instance, while the USP code is dozens of pages long.

The USP standard is chock-full of specifics -- how many particles can be in a room's air, what size and kinds of filters pharmacists need, minimum times and temperatures for sterilizing items and more.

Oregon's code is more general. For instance, it says drug-mixing areas "shall have clean surfaces" and "avoid outside traffic and air flow," without giving measurements for what is good enough.

"There really is nothing that addresses nonsterile compounds directly" in Oregon's rules today, Schnabel said. The new code would add detailed standards for making those compounds.

The independent accrediting board set up in 2004 requires compounders to meet USP standards, Baker said. But it has more extensive standards, covering topics including what kinds of advertising is allowed and who pharmacists can buy chemicals from.

Getting accredited "is not easy to do," Baker said. "You have to spend a lot of money to meet these standards," including buying high-tech equipment and paying up to $5,000 in annual fees to the board. The board says pharmacies that get its seal of approval should have an advantage over nonaccredited competitors. So far, 19 compounders have been accredited and 103 are going through the process, including a Washington pharmacy.

No Oregon compounders have applied for accreditation yet, Baker said.