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.
DISCIPLINARY ACTIONS
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.
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