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Calif. Proposes New Standards for Sterile Compounding

Donna Young

After a year of considering standards for the compounding of sterile preparations, the California Board of Pharmacy, based on comments it received from the public, has decided to throw out its draft and propose a new set.

The board plans to publish its new draft on Feb. 21, said Paul Riches, legislative analyst for the board.

Improperly compounded betamethasone injection was blamed in 2001 for the deaths of three patients in California. Later that year, the legislature passed a law that requires the state’s board of pharmacy to adopt regulations establishing standards for sterile compounding.

The board proposed its first draft of the standards in January 2002, which subsequently underwent several revisions.

Riches said the previously proposed draft included guidelines on the compounding of all sterile drug preparations.

But after being pressured by wide opposition to rules governing the sterile compounding of noninjectable preparations, the board decided to work only on establishing standards for category 3, or sterile, injectable drug preparations, Riches said.

The draft standards will be open for public comment for 45 days after the publication date, he noted.

The board is scheduled to hold a public hearing about the draft standards in Sacramento, Calif., on April 29.

Once approved by the board, the standards must be accepted by the state’s Consumer Affairs Division and the Office of Administrative Law. The acceptance and implementation processes could take anywhere from four months to a year to complete, Riches noted.

While not clearly apparent in the draft standards, Riches said that, for the preparation of parenteral cytotoxic agents, California pharmacists are required to follow codes, known as Title 24, established by the state’s Building Standards Commission.

Section 505.12.1 of Title 24 states that, "all compounding shall be conducted within a certified Class II Type A or Class II Type B laminar flow with bag in-bag out design. The pharmacy must ensure that contaminated air plenums that are under positive air pressure are leak tight."

Riches said that the publication in March of United States Pharmacopeia (USP) Chapter 797, containing compounding guidelines, in The United States Pharmacopeia and the National Formulary (USP-NF) will have no effect on California’s standards because "laws defining pharmacy practice are state laws."

USP-NF chapters numbered below 1000 are enforceable by the Food and Drug Administration (FDA), whereas chapters 1000 through 1999 are informational.

But Riches said there is no California law that gives USP the force of law in his state.

"I have heard a number of times about USP standards numbered under 1000 as ‘mandatory,’ but I can’t establish a legal basis for that judgment under California law," he said.

The only circumstance in which FDA can insert itself into a pharmacy's conduct is if that pharmacy is engaged in manufacturing as opposed to compounding, Riches argued.