Reminder by ISHP in Idaho that Drug items compounded for "office use" and not patient specific are considered to be manufacturing by both Federal and State law; and that USP Chapter 800 is open for comments

Legal and Public Affairs Update
John Sullivan

As we move through spring and enjoy the change in the weather there are a few items I wanted inform and/or remind our members about. The first item is to remind us all that compounded drug products must be pursuant to a patient specific prescription order. Drug items compounded for "office use" and not patient specific are considered to be manufacturing by both Federal and State law. Only registered outsourcing facilities may compound for office use. A list of registered pharmacies can be found at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm.



The board of pharmacy is enforcing this for all sterile compounded products, so ensure that your practices are following current law.

Another item related to compounding is the proposed USP General Chapter 800 related to compounding of Hazardous Drugs. There is an open comment period available through July 31, 2014. You can view the proposed chapter by following the link: http://www.usp.org/usp-nf/notices/compounding-notice. This chapter applies to all personnel who are involved in handling hazardous drugs including those not in your pharmacy departments. I encourage all of you that handle hazardous drugs to review the chapter and follow the instructions listed on the website should you have any comments.

quoted from ISHP May 2014 Newsletter

Idaho Board of Pharmacy Addressing a number of compounding issues including issuing cease and desist letters to compounding pharmacies that do not obtain a patient specific prescription--Enforcement is coming in Idaho

Johnston reported that the Board had traditionally believed that a pharmacy that repackaged drugs that were previously dispensed by another pharmacy was required to be registered as a repackaging manufacturer by the FDA. However, Mr. Johnston found an FDA Guidance Document issued in 1991, which is still effective today, that explains that such repackaging is acceptable, if conducted within the practice of pharmacy. Mr. Johnston presented collated rule language from other states that allow such a practice. Ed Snell, RPh, appeared to request rule promulgation that would allow and regulate such repackaging. Mr. Snell explained the need for repackaging when retirees of the railroad receive mail order prescriptions in vials and the retirees are subsequently institutionalized. The Idaho Department of Health and Welfare requires drugs within an institutional facility to be unit dose packaged, thus the issue at hand. The Board directed Mr. Johnston and Ms. McKay to proceed with penning rules regarding repackaging in pharmacies.

During Legislation and Rule Review Mr. Johnston explained that the Board’s staff has received oral reports of chiropractors receiving compounded drugs from mail order pharmacies. Chiropractors don’t have prescriptive authority in Idaho and mail service pharmacies should not be dispensing or distributing to them. Mr. Johnston reported that a bill may be introduced to grant chiropractors limited prescriptive authority. If a chiropractor bill is introduced, Mr. Johnston was directed to explain the current issues, but take no position.

Chairman Chopski asked for public comment. Elaine Ladd, PharmD owner of Ladd’s Family

Pharmacy, explained she is losing business to mail service pharmacies because she won’t provide ‘office use’ compounds, since the enactment of the Compounding Quality Act. The Board directed Mr. Johnston to begin enforcing patient specific compounding on a priority basis, starting with high risk, out of state compounders, while the Board awaits further FDA clarification of the Compounding Quality Act. The Board directed Mr. Johnston to report such pharmacies to the FDA and to send a letter to cease and desist. Dr. de Blaquiere requested that Mr. Johnston pen an article for the Board newsletter reminding pharmacists that distribution of compounded drug product in the absence of a patient specific prescription drug order is not legal in Idaho and that enforcement is coming.

Mr. Johnston reiterated the Board’s decision from the 1/9/14 Board meeting to withdraw the Board’s pending compounding rules. Mr. Johnston explained changes to the Board’s bill that would allow Southworth associates access to PMP data that related to enrollees in the PRN program. The language now allows an individual to designate another to receive the individual’s data, which accomplishes the Board’s directive with less controversy. There are no other changes to the Board’s pending rules or draft bills.

quoted from January 2014 Minutes of Idaho Board of Pharmacy found here

Idaho Board of Pharmacy Agenda for May 29, 2014 Meeting

Next Board Meeting

Date: May 29, 2014
Location: Coeur d'Alene, ID
Map: Coeur d'Alene Resort
Room: Bay 1
Time(PST): 8:00am to 5:00pm

Agenda

Board Packet Updated 5/28/14 4:26pm (Board Members Only)

Idaho Board of Pharmacy Draft Rule Docket Compounding Rules

Draft Rule Dockets:

Compounding Rules 27-0101-1301