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In reaction to health hazards associated with compounded drugs, the California Pharmacy Board has been in the process of rulemaking to more closely regulate compounded drugs that are dispensed in California. The latest proposed regulations are now subject to a public regulation hearing: on November 4, 2014 at 10:30 a.m. at the Department of Consumer Affairs Headquarter Building Two located at 1747 N. Market Blvd., Room 186 in Sacramento, The 45-Day comment period: runs from September 5, 2014 to October 20, 2014.

Existing state and federal law specifically attempts to limit compounding to limited quantities for an identified patient with unique needs. This limit supposedly differentiates a manufacturer who is subject to FDA scrutiny, from a compounding pharmacist who is only scrutinized by individual states. The proposed regulations make changes to existing law on the topics of a definition of a “limited quantity” and how the distribution chain can occur from the compounding pharmacist to a dispensing physician who supposedly has a “limited quantity” of compounded medication on hand that escapes the definition of an FDA regulated “manufactured product.”

Unfortunately, the proposed regulations do not seem to consider the abuse that occurs in the California workers’ compensation arena when a seemingly endless supply of compounded pharmaceuticals are supplied in bulk to a dispensing physician, and then mechanically prescribed and dispensed to injured workers at inflated prices, all of which is claimed to be within the limits of existing federal and state law. What we see seems more like manufacturing than compounding for an identified patient. For this reason, NOW is a good time for the workers’ compensation community to alert the Pharmacy Board about the unique situation that now occurs quite often in our claims. Perhaps with our guidance, the current version of its regulations could be yet amended again to address the concerns that we see in claims about compounded pharmaceuticals. For those so inclined to make any comments to the Board of Pharmacy on its proposed compounded pharmaceutical regulations, they may read the materials on this page..

Under the current federal regulatory system, drug manufacturers are regulated by the Food and Drug Administration (FDA). Prior to the enactment of the Drug Quality and Security Act, compounding pharmacies were regulated by their respective states of residence. Compounding pharmacies also make drugs, but they are limited to producing small amounts in response to a specific patient’s prescription, or to create a small supply for an identifiable patient population to ensure continuity of treatment. The state-by-state approach to regulating compounding organizations yields inconsistent standards and varying levels of enforcement on an industry that ships dangerous drugs across state lines.

Included as part of the federal Drug Quality and Security Act (HR 3204) that became law on November 27, 2013, are provisions that establish provisions for federal regulation and oversight of large scale drug compounding by “outsourcing facilities.” The federal law sets forth voluntary requirements for licensure and enforcement of these entities. However, California’s law is more restrictive than the federal law in several areas. California will continue to require any pharmacy that is compounding sterile products for California residents or practitioners to possess licensure with the board and comply with California requirements as sterile compounding pharmacies.

SB 294 commencing July 1, 2014, expands the provisions of the California Pharmacy Law to prohibit a pharmacy from compounding or dispensing, and a nonresident pharmacy from compounding for shipment into this state, sterile drug products for injection, administration into the eye, or inhalation, unless the pharmacy has obtained a sterile compounding pharmacy license from the board. SB 294 also specifies requirements for the board for the issuance or renewal of a license, and requirements for the pharmacy as a licensee. SB 294 requires the board to adopt regulations to implement these provisions, and, on and after July 1, 2014, to review formal revisions to specified national standards relating to the compounding of sterile preparations to determine whether amendments to those regulations are necessary, as specified.

Additionally, there are compounding professional standards that are used across the nation known as the United States Pharmacopeia and The National Formulary (USP-NF). USP-NF is a book of public pharmacopeial standards. It contains standards for (chemical and biological drug substances, dosage forms, and compounded preparations), excipients, medical devices, and dietary supplements. USP-NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP. Excipient monographs are in the NF. The U.S. Federal Food, Drug, and Cosmetics Act designates the USP-NF as official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP-NF to avoid possible charges of adulteration and misbranding.

At the October 2013 Board Meeting, the board moved to initial notice of proposed changes in the California’s compounding regulations (located in 16 California Code of Regulations Sections 1735 et seq. and 1751 et seq). This regulatory process has continued to develop the present version of proposed new regulations. .