VERY Important Notice From Idaho Board of Pharmacy Regarding DQSA Conflicting with board's pending compounding rules--Idaho to immediate start enforcement of rule prohibiting "office use"

Compounding

On November 27, 2013, President Barack Obama signed the Compounding

Quality Act into law, available at www.fda.gov/Drugs/

GuidanceComplianceRegulatoryInformation/PharmacyCompounding/

ucm376732.htm. The Federal Food, Drug, and Cosmetic Act, Section

503A, now is clearly federal law, minus the unconstitutional advertising

prohibitions. Section 503A is available at www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/PharmacyCompounding/ucm376733

.htm. Shortly after the president signed, Food and Drug Administration

released a draft guidance document, available at www.fda

.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/

Guidances/UCM377052.pdf.

The Compounding Quality Act conflicted with so many portions of

the Board’s pending compounding rules that the Board asked the 2014

Idaho Legislature to reject said docket of rules in full. The Board expects

to rewrite the pending compounding rules later this year.

All compounders are encouraged to read and understand this federal

law. While this Newsletter will not attempt to summarize the Compounding

Quality Act, Idaho law is in harmony with federal law in at least

one place, as both prohibit pharmacies from distributing “office use”

compounded drug product. Pharmacies must dispense compounded

drug product pursuant to a patient-specific prescription drug order. The

Board will immediately begin enforcement of such law on a priority

basis, starting with the highest risk compounding: sterile compounded

drug products distributed across state lines into Idaho.

Idaho Code, Section 54-704, reads: “nothing in the [Chiropractic Practice

Act] CPA shall allow any chiropractor to direct or suggest a patient

use a substance that requires the label ‘Caution: Federal law prohibits

dispensing without a prescription.’” In the past, the Board has entered

into stipulated orders with wholesalers who have distributed prescription

items to Idaho chiropractors. The substantial fines contained within these

orders seemed to be a successful deterrent to such illegal distribution,

but it has recently come to the attention of the Board that compounding

pharmacies may have been supplying chiropractors with prescription

items. Such distribution or dispensing is subject to discipline, up to and

including license and/or registration revocation.

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