MAY 2001 STATE BOARD NEWS
(STATE SECTION ONLY)
This is one final reminder about the continuing education (CE) requirements that take effect with the pharmacist license renewals this year. All pharmacists (except those newly licensed) whose license numbers begin with 03-1 will be required to show 6.0 CEUs (60 hours) of continuing education credit. Of those 6.0 CEUs, 4.5 CEUs (45 hours) must be in patient care related courses (course numbers ending in 01 or 02) and 0.3 CEUs (3 hours) must be in Board-approved Jurisprudence (course numbers ending in 03 and are Board-approved courses). The other 1.2 CEUs (12 hours) may be in any category (01, 02, 03, or 04). If you are not sure that your jurisprudence is Board-approved, please check with the provider. All pharmacists who do not have to report continuing education this year will be required to meet these requirements the next time they report. Those pharmacists whose license numbers begin with 03-2 will be reporting next summer (2002) and those whose license numbers begin with 03-3 will be reporting during the summer of 2003.
It is now possible to verify the license status of any pharmacist or intern licensed in Ohio by visiting our Web site, www.state.oh.us/pharmacy. Click on “License Verification," then click on “Pharmacists and Pharmacy Interns” and you will be able to search by name or license number. To search by name, it is not necessary to spell the pharmacist’s name completely; the first letter or the first few letters will initiate the search. Once you find the person you are looking for, click on his/her name and you will be taken to a screen that tells you basic information about the licensure status of the individual. In addition, the final box on the form is labeled “Formal Action”. If there has been any Ohio State Board of Pharmacy action taken against that pharmacist or intern, the box will indicate this and you will either be instructed to call the Board office for details or you will be able to transfer to a copy of any Board Orders relating to this individual.
By the time this Newsletter is published, we should also have the ability to review the license status of terminal and wholesale distributors. The information on these licenses will include the name of the person responsible for the license in addition to the status and legal history of the license.
The issue of pharmacists compounding individual patient medications to meet specific needs has been in the news lately. For many years, this has been a controversial topic on a national level that has led to much discussion and disagreement among regulators, pharmacists, physicians, patients, and manufacturers. The federal law that had done so much to clarify the issues involved, 21 USCA §353a, was recently declared invalid in its entirety by the federal Ninth Circuit Court of Appeals. This court agreed with the federal district court, which had found that the advertising restrictions contained in Section (c) were unconstitutional. However, the Ninth Circuit Court of Appeals went even further by stating that the advertising section could not be severed from the rest of the law because Congress would not have passed this section of the law without the advertising prohibition. In addition, even though there is a section of the federal Food, Drug, and Cosmetic Act (21 USCA §391), which states that the unconstitutionality of one part does not invalidate an entire section, this Court chose to discount the applicability of that particular section since Congress did not repeat it in the 1997 Food and Drug Administration (FDA) Modernization Act that gave rise to §353a.
While one may certainly question the wisdom and the accuracy of the decision made by the Ninth Circuit Court of Appeals on these two additional issues, the fact remains that 21 USCA §353a has been declared invalid by this Court. The effect of this decision is that it puts the compounding issue back to the state level, where it probably belongs anyway.
In Ohio, a prescription is defined in the Revised Code as “an order for drugs or combinations or mixtures of drugs to be used by a particular individual” [Section 4729.01(H)]. This means that a prescriber may issue a prescription for a compounded product for a particular patient and the pharmacist may prepare the product and dispense it to that patient. Compounding is part of the practice of pharmacy and the Board supports an individual pharmacist who wishes to practice this way. The key to this process is the fact that it is done for an individual patient. Otherwise, the combination of two or more drugs to make another product (other than by an individual patient prescription) would be considered to be manufacturing. This requires licensure with the FDA and compliance with the federal law found in 21 USCA §355, which requires a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) to be filed with the FDA.
On September 15, 1993, the Ohio State Board of Pharmacy issued Compliance Bulletin 93-002 which said in part “State and federal laws and regulations authorize pharmacists to COMPOUND PRESCRIPTIONS in the course of their professional practice. Pharmacists are not authorized by either federal or state law to MANUFACTURE DRUGS.” This warning remains valid today. Pharmacists need to ensure that they are compounding and not manufacturing when they prepare products for patient use.
Anyone having a question regarding the license status of a particular practitioner, nurse, pharmacist, pharmacy intern, or dangerous drug distributor in Ohio should contact the appropriate licensing board. The Web sites listed below may include disciplinary actions for their respective licensees.
State Dental Board--614/466-2580, www.state.oh.us/den/
State Medical Board--614/466-3934, www.state.oh.us/med/
State Nursing Board--614/466-3947, www.state.oh.us/nur/
State Optometry Board--614/466-5115, www.state.oh.us/opt/
State Pharmacy Board--614/466-4143, www.state.oh.us/pharmacy/
State Veterinary Medical Board--614/644-5281, www.state.oh.us/ovmlb/
Drug Enforcement Administration--800/230-6844; www.deadiversion.usdoj.gov/
STATE PHARMACY BOARD:
The disciplinary actions listed below include only those in which the individual’s license to practice has been suspended, revoked, or restricted, and does not include any other actions taken by the Board. All actions may be seen in the minutes, which are posted on the Internet at the Board's Web site (see address above) then click on "Board Minutes."
Orders of the Board:
Katherine Marie Blair, R.Ph.; Canton - License revoked effective 01/12/01.
Brenda S. Bland, R.Ph.; Centerville - License suspended indefinitely effective 03/09/01 and may not be employed by or work in a facility licensed by the Board while suspended.
Dennis L. Carey, R.Ph.; Groveport - License revoked effective 02/12/01.
Joseph Neil Gioiello, R.Ph.; Warren - License suspended indefinitely effective 12/18/00 and may not be employed by or work in a facility licensed by the Board while suspended.
Eric Wayne Hamon, R.Ph.; Sebring - License suspended indefinitely effective 03/09/01 and may not be employed by or work in a facility licensed by the Board while suspended.
Frank Lancz, R.Ph.; Toledo - License revoked effective 04/12/00.
Randolph D. Mosier, R.Ph.; Cleveland - License revoked effective 12/11/00.
Thomas Allen Oswald, R.Ph.; Wadsworth - License suspended indefinitely effective 02/12/01 and may not be employed by or work in a facility licensed by the Board while suspended.
Steven Martin Salo, R.Ph.; Conneaut - License suspended indefinitely effective 03/09/01 and may not be employed by or work in a facility licensed by the Board while suspended.
Joseph R. Tabler, R.Ph.; Cincinnati - License revoked effective 10/06/00.
Summary Suspensions: [Sec. 3719.121 of the Revised Code]
Robert J. Garrity, R.Ph.; Lakewood. Effective 02/08/01.
Richard Hart, R.Ph.; Hamilton. Effective 01/09/01.
Vernon A. Infantino, R.Ph.; Concord Twp. Effective 04/05/01.
Michael H. Linhart, R.Ph.; Salem. Effective 03/13/01.
Charles R. Willson, R.Ph.; Berlin Center. Effective 03/13/01.
STATE MEDICAL BOARD:
A document of legal actions taken by the Medical Board may be accessed on the Internet at the Medical Board's Web site (see address above) then click on "Monthly Formal Actions." If you would like a more detailed history of a legal action for an individual practitioner, go "Back" to the Medical Board's Home page, click on the "Licensee Profile & Status" tag, then follow the instructions. Please contact the Medical Board if you have questions.