Kansas News: New Regulations

Published in the December 2009 Kansas State Board of Pharmacy Newsletter

On November 13, 2009, an amendment to K.A.R. 68-20-16 related to controlled substance inventories became effective. The regulation will now require an inventory of all controlled substances to be done every year. Ev¬ery person is required to take an initial inventory of all stocks of controlled substances on the date he or she first engages in the dispensing of controlled substances. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand every year. If the substance is listed in Schedule I, II, or contains hydrocodone, an exact count or measure of the contents shall be recorded. If the substance is listed in Schedule III, IV, or V and does not contain hydrocodone, an estimated count or measure of the contents must be taken, unless the container holds more than 1,000 tablets or capsules in which an exact count must be taken. This regulation is stricter than federal law which requires a biennial inventory. The inventory may be taken at the opening of business or as of the close of business on the inventory date and it shall be indicated on the inventory. Each inventory should be signed and dated. Inventory records shall be maintained a minimum of five years in the pharmacy.
On October 23, 2009, several amendments to regula¬tions became effective. One amendment was made to K.A.R. 68-2-22 related to electronic prescription trans¬missions. If a prescription or drug order is communicated by an electronic transmission it needs to be maintained as either a hard copy or an electronic document. Therefore, a phoned in and faxed in prescription must be maintained for a minimum of five years as either a hard copy or an electronic document. If the copy is maintained as an electronic document it must be retrievable and available to the pharmacy inspector if requested.
K.A.R. 68-1-1h is related to foreign pharmacists. A pharmacist who graduated from a school outside the United States or who is not a citizen of the United States has to provide proof that they are proficient in English. In addition to taking an English language test the indi¬vidual must take and pass the Foreign Pharmacy Gradu¬ate Equivalency Examination® (FPGEE®) with a score of at least 75. When the graduate has successfully passed the FPGEE and the English proficiency test they will be given a Foreign Pharmacy Graduate Examination Com¬mittee™ (FPGEC®) certificate, which must be submitted to the Kansas State Board of Pharmacy. This regulation clarified the foreign pharmacist requirements.
K.A.R. 68-1-3a clarified qualifying pharmaceutical experience requirements of interns. Each intern must obtain 1,500 clock hours as a pharmacy student or intern while being supervised by a preceptor. The preceptor may supervise no more than two individuals at any one time. The intern may not receive more than 60 hours during any one week. The intern may not obtain hours prior to being accepted in an approved school of pharmacy and he or she may not obtain intern hours prior to being registered with the Board of Pharmacy. Foreign pharmacy graduates who have obtained their FPGEC certificate may apply for registration as an intern. Once an intern is registered he or she must complete 1,500 hours within six years. Pharmacists who are applying for licensure by transfer¬ring from another state will not be denied a license in Kansas if they have met the internship requirements of the state from which they are reciprocating and have at least one year of experience as a pharmacist.
The last change that was effective on October 23, 2009, was the amendment made to K.A.R. 68-7-14 regarding prescription labels. The only change that was made to this regulation was that the label for each drug or device shall include the name of the prescriber. The prescription label no longer requires the name of the mid-level practitioner and the supervising physician to be on the label. The label may still have both the name of the physician and the physician assistant (PA)/advanced registered nurse practitioner (ARNP) or the label may only indicate the PA/ARNP’s name followed by the proper designation. The actual prescription still requires the name of the mid-level practitioner and his or her supervising physician on the prescription. These are Kansas State Board of Healing Arts and Kansas State Board of Nursing requirements that the Board of Pharmacy has no jurisdiction over. A prescription is not valid if it does not contain the name of the mid-level practitioner who prescribed the drug, and the supervising practitioner.
These changes can all be found on the Board of Phar¬macy Web page at www.kansas.gov/pharmacy under Kan¬sas Pharmacy & Related Laws, under the link for Newly Approved Regulations with the title “New Regulations.”