Showing posts with label Ohio State Board of Pharmacy. Show all posts
Showing posts with label Ohio State Board of Pharmacy. Show all posts

Friday, February 8, 2013

Ohio State Board of Pharmacy Feb. 4-5 Meeting Included Hearings Relating to Compounding Pharmacies


OHIO STATE BOARD OF PHARMACY
77 South High Street, Room 1702; Columbus, OH 43215-6126
-Equal Opportunity Employer and Service Provider-
TEL: 614/466-4143 E-MAIL: exec@bop.ohio.gov FAX: 614/752-4836
TTY/TDD: Use the Ohio Relay Service: 1-800/750-0750 URL: http://www.pharmacy.ohio.gov
S U N S H I N E N O T I C E
The next meeting of the State Board of Pharmacy should be held in Room East B, 31st Floor, Vern Riffe Center for
Government and the Arts, 77 S. High Street, Columbus, Ohio according to the following schedule with all sessions
being open to the public unless otherwise indicated:
Monday, February 4, 2013
10:00 a.m. ROLL CALL/EXECUTIVE SESSION (Closed Session)
10:05 a.m. ADMINISTRATIVE MATTERS ~ Old & New Business/Correspondence Reports/Matters To Be
Adjudicated (No Hearing Requested)- Pharmfinders, LLC, c/o Ryan Hackler, CEO, Tulsa,
Oklahoma
1:30 p.m. ADJUDICATION HEARING- Risa Gethers, R.Ph., West Chester, Ohio
1:30 p.m. ADJUDICATION HEARING- Buckeye Family Medicine, Inc. c/o Rosalie A. Kuriakose, M.D.,
Columbus, Ohio
Tuesday, February 5th, 2013
8:00 a.m. ROLL CALL / ADMINISTRATIVE MATTERS (continued)
8:00 a.m. ADJUDICATION HEARING- Albert D. Fischer, R.Ph., Broadview Heights, Ohio
10:30 a.m. ADJUDICATION HEARING- The Compounding Center, Inc. c/o Joel Gomez, Scottsdale, Arizona
1:30 p.m. RECIPROCITY CANDIDATES REVIEW (Room South-A, 31st Floor)
2:00 p.m. ADJUDICATION HEARING- Jeremy Webster, Intern, Findlay, Ohio
2:30 p.m. ADJUDICATION HEARING- Bryan Dennis Bowman, R.Ph., Mason, Ohio
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Contact: Kyle W. Parker, M.B.A., R.Ph., Executive Director
Mail: 77 South High Street, Room 1702; Columbus, OH 43215-6126
Tel: 614/466-4143
Fax: 614/752-4836

Saturday, January 5, 2013

In Ohio Compounding pharmacies face new scrutiny


Posted: Saturday, January 5, 2013 12:00 pm | Updated: 5:02 pm, Fri Jan 4, 2013.
LIMA — The facility responsible for the deadly meningitis outbreak in late 2012 was known as a “compounding pharmacy.” However, that Massachusetts facility was a commercial prescription manufacturer, and in reality comparing it to a true compounding pharmacy would be like comparing a mass-food producer with someone cooking in his kitchen. Still, the problems found at the New England Compounding Center have meant increased scrutiny for small compounding pharmacies that mix ingredients for a single prescription. A new report released in December by the National Conference of State Legislatures said several states changed laws regarding regulation of compounding pharmacies and locally, pharmacists report increased inspections.
“You can expect something like that to come out of any event. If there’s an oil spill, everyone gets a closer look,” said John Pack, owner of Pack Pharmacy, which is Lima’s only compounding pharmacy.
Pack said compounding is more complicated than regular pharmacy work.
“We’re doing more, and more is expected of us. People need reassured,” Pack said. “So, two weeks ago, we had the most thorough inspection I’ve ever experienced. It was a surprise visit. You know, business just stops for them. But, it was very positive. We had nothing at fault. They did some educational things; they’re trying to get a more consistent way of keeping records.”
continue reading here

Sunday, December 2, 2012

OOS Representatives TO Meet With The Ohio Pharmacy Board To Discuss Enforcement Of Regulations Surrounding The Purchase Of Avastin From Compounding Pharmacies


11/28/2012

Last week the OOS made a formal meeting request to the Ohio State Board of Pharmacy to discuss the enforcement of current rules surrounding the purchase of Avastin from compounding pharmacies. We hope to hear back in the next several days regarding a proposed meeting date.

As you know, attention at the federal and state level regarding the regulation of drugs distributed from compounding pharmacies has increased dramatically since the deadly fungal meningitis outbreak linked to the New England Compounding Center. While Congress continues to investigate the current level of oversight and discusses developing legislation to create new regulations, state pharmacy boards are focused on enforcing current state level requirements.
The OOS has heard from several practices that have already been investigated or have questions about the current regulations. For a complete copy of the Ohio State Board of Pharmacy’s fact sheet Compounding in Ohio click here. The OOS has heard from several practices that are concerned that a number of the existing provisions make it extremely difficult for most practices to purchase and administer Avastin and potentially compromise what would be considered good patient care. The OOS is aware of these issues and will be articulating them to the Pharmacy Board.
We will update OOS members when we have a meeting date, and additional information to provide, from the Pharmacy Board. Should you have any questions now or in the future, please contact the OOS office directly at (614) 527-6799 or email us at tbaker@ohioeye.org.

Saturday, November 17, 2012

Ohio Board of Pharmacy Guidance Regarding Compounding in Ohio


COMPOUNDING IN OHIO
We recognize and enforce Federal law that compounding is performed by a pharmacist in a
pharmacy and pursuant to a patient specific prescription.  Refer to 21 USCA 353a
 You may not compound FDA approved drugs that are commercially available.
 On July 9, 2012, President Obama signed into law the FDA Safety and Innovation
Act which in part grants permission for hospitals and health systems to repack and
share drugs, not controlled substances, in short supply during an FDA published
shortage plus 60 days after the drug is taken off the list. Caveat: only within the
same health system    
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/Significant
AmendmentstotheFDCAct/FDASIA/ucm313121.htm
Our state law defines compounding in ORC 4729.01(C)
(C) “Compounding” means the preparation, mixing, assembling, packaging, and
labeling of one or more drugs in any of the following circumstances:
(1) Pursuant to a prescription issued by a licensed health professional authorized
to prescribe drugs;
(2) Pursuant to the modification of a prescription made in accordance with a
consult agreement;
(3)  As an incident to research, teaching activities, or chemical analysis;
(4) In anticipation of orders for drugs pursuant to prescriptions, based on routine,
regularly observed dispensing patterns;
(5) Pursuant to a request made by a licensed health professional authorized to
prescribe drugs for a drug that is to be used by the professional for the purpose
of direct administration to patients in the course of the professional’s practice,
if all of the following apply:
(a) At the time the request is made, the drug is not commercially available
regardless of the reason that the drug is not available, including the
absence of a manufacturer for the drug or the lack of a readily available
supply of the drug from a manufacturer.
(b) A limited quantity of the drug is compounded and provided to the
professional.Compounding in Ohio
Page 2 of 5 rev 9/12
(c) The drug is compounded and provided to the professional as an
occasional exception to the normal practice of dispensing drugs pursuant
to patient-specific prescriptions.
Note: also refer to OAC 4729-9-25 below for specifics relating to (5)
We further regulate compounding in the following rules:
DRUGS COMPOUNDED IN A PHARMACY      OAC Rule 4729-9-21
Please review particularly:
(F) A prescription shall be compounded and dispensed only pursuant to a
specific order for an individual patient issued by a prescriber. A
limited quantity may be compounded in anticipation of prescription drug
orders based on routine, regularly observed prescribing patterns.
(G) A compounded prescription that is dispensed to a patient must be
labeled according to rule 4729-5-16 of the Administrative Code.
DRUGS COMPOUNDED FOR DIRECT ADMINISTRATION BY A PRESCRIBER
OAC Rule 4729-9-25
Please review particularly:
A pharmacist may compound a drug pursuant to a request made by a
prescriber, or by an agent of the prescriber, for a drug to be used by the
prescriber for the purpose of the direct administration to patients in the
course of the prescriber's practice pursuant to division (C)(5) of section
4729.01of the Revised Code and the following:
(A) The drug is compounded and provided to a prescriber as an occasional
exception to the normal practice of dispensing drugs pursuant to patient
specific prescriptions:
(1)  A pharmacy may provide compounded drug preparations to
prescribers for direct administration to patients as long as the total
value of those compounded preparations does not exceed five percent
of the pharmacy's total dollar amount of sales of patient specific
compounded prescriptions within the past twelve months.
(2) The pharmacy shall only provide those compounded drugs that are
not commercially available to a prescriber which are needed:
(a) To treat an emergency situation;
(b) For an unanticipated procedure for which a time delay would
negatively affect a patient outcome;
(c) For diagnostic purposes.
(B) A pharmacy shall not supply more than a seventy-two hour supply of a
compounded drug to a prescriber. A prescriber shall not have more than
a seventy-two hour supply of a compounded drug on hand at any given
time. The seventy-two hour supply provided to the prescriber shall be
determined by previous administration patterns provided by a Compounding in Ohio
Page 3 of 5 rev 9/12
prescriber to the pharmacist. The limitation of a seventy-two hour
supply shall not apply to either of the following:
(1) Compounded non-sterile drug preparations for topical administration,
pursuant to paragraphs (A)(2)(b) and (A)(2)(c) of this rule, shall be
supplied to a prescriber in a single container in which the quantity
does not exceed sixty grams or sixty milliliters. A prescriber shall not
have more than one full container of sixty grams or sixty milliliters of
a compounded drug on hand at any given time; or
(2) Compounded non-sterile drug preparations intended to treat an
emergency situation, pursuant to paragraph (A)(2)(a) of this rule, may
be provided to a prescriber in a quantity required to sufficiently treat
individuals in the event of an emergency situation.
(C) A pharmacy shall not sell a compounded drug to another pharmacy
or wholesaler.
(D) Prescribers shall only administer a requested compounded drug directly
to their own patients. Prescribers shall not:
(1) Dispense a compounded drug to a patient;
(2) Sell a compounded drug to another prescriber;
(3) Sell a compounded drug to a pharmacy; or
(4) Return a compounded drug to the supplying pharmacy.
(E)  Compounded drug preparations shall be assigned beyond use dates
that are based on stability and sterility for sterile compounded drug
preparations and stability for non-sterile compounded drug preparations
pursuant to the following:
(1) Beyond use dates for non-sterile compounded preparations shall be
determined by the compounding pharmacy through drug product
testing pursuant to acceptable practice standards; by published peer
reviewed pharmaceutical literature that have been critically reviewed
by unbiased independent experts; or in compliance with requirements
in the current edition of an official compendium, such as the "United
States Pharmacopoeia/National Formulary".
(2) Beyond use dates for sterile compounded preparations shall be
determined by the compounding pharmacy through drug product
testing pursuant to acceptable practice standards or shall be based on
the following "United States Pharmacopoeia/National Formulary"
standards:
(a) Low risk level compounded drug preparations shall be assigned a
beyond use date of not more than forty-eight hours when stored
at controlled room temperature at twenty to twenty-five degrees
celsius, or fourteen days when refrigerated at two to eight
degrees celsius, or forty-five days in solid frozen state at minus
twenty-five to minus ten degrees celsius.
(b) Medium risk level compounded drug preparations shall be
assigned a beyond use date of not more than thirty hours when
stored at controlled room temperature at twenty to twenty-five
degrees celsius, or nine days when refrigerated at two to eight Compounding in Ohio
Page 4 of 5 rev 9/12
degrees celsius, or forty-five days in solid frozen state at minus
twenty-five to minus ten degrees celsius.
(c) High risk level compounded drug preparations shall be assigned
a beyond use date of not more than twenty-four hours when
stored at controlled room temperature at, twenty to twenty-five
degrees celsius, or three days when refrigerated at two to eight
degrees celsius, or forty-five days in solid frozen state at minus
twenty-five to minus ten degrees celsius.
(F) The labeling of a compounded drug preparation must contain the
following:
(1)  The statement "For direct patient administration only" displayed
prominently;
(2)  The statement "Not for resale" displayed prominently;
(3)  Proper storage conditions;
(4)  Beyond use dates pursuant to paragraph (E) of this rule;
(5)  The name(s) of the active and inactive ingredients;
(6)  The amount or percentage of active drug ingredients;
(7)  The quantity of compounded drug provided;
(8)  The route of administration;
(9)  The pharmacy name, address, and telephone number;
(10) The pharmacy control number assigned to the compounded drug
preparation.
(G) Compounded drug preparation containers that are too small to bear a
complete label pursuant to paragraph (F) of this rule must bear a label
that contains at least the following information:
(1) "Not for resale";
(2) The storage conditions if other than room temperature;
(3) The beyond use date;
(4) The drug name(s);
(5) The drug strength;
(6) The route of administration;
(7) The pharmacy control number;
(8) The pharmacy name.
In all cases, a complete label meeting the requirements of paragraph (F)
of this rule must be applied to the outside container in which such
compounded preparation is supplied.
(H) The sale of a compounded drug preparation to a prescriber is
considered a wholesale sale as defined in section 4729.01 of the
Revised Code. A pharmacy is required to follow the record keeping
requirements for wholesale sales listed in paragraph (H) of rule 4729-9-
16 of the Administrative Code.
(I) A pharmacy must follow the compounding requirements pursuant to
rules 4729-5-25 and 4729-9-21 of the Administrative Code, Chapter
4729-19 of the Administrative Code, current professional
compounding standards, and all applicable federal and state laws,
rules, and regulations.Compounding in Ohio
Page 5 of 5 rev 9/12
In addition, all prescriptions must be sent to the PATIENT
If you want to ship ANY patient specific medications to the prescriber rather than the patient,
you must have Board approval (specific to each prescriber office/pharmacy) prior to any such
shipment pursuant to
PRESCRIPTION PICK-UP STATION    OAC Rule 4729-5-10
Please review particularly:
(B)  No pharmacist shall dispense dangerous drugs to a place which offers, in
any manner, its services as a "pick-up station" or intermediary for the
purpose of having prescriptions filled or delivered unless such place is a
pharmacy as defined in section 4729.01 of the Revised Code, has
received board approval to function in such a manner, and paragraphs
(B)(1) to (B)(4) of this rule apply or, if not a pharmacy, unless all of the
following apply:
(1)  The site is appropriately licensed pursuant to Chapter 4729. of the
Revised Code.
(2)  The receipt, storage, control, and distribution of prescriptions or
drugs are in the full and actual charge of a health care professional
licensed pursuant to Chapter 4715., 4723., 4729., 4730., 4731., or
4741. of the Revised Code.
(3) An appropriate recordkeeping system is in place that will provide
accountability for proper receipt, delivery, and return of all
prescription medications.
(4) There is a documented method in place to ensure compliance with
rule 4729-5-22 of the Administrative Code.
(5) The state board of pharmacy has approved the site for such activity
due to clear and convincing evidence that delivery of prescription
medication directly to the patient would result in:
(a) Danger to public health or safety, or
(b) Danger to the patient without increased involvement by a health
care professional in the patient’s drug therapy.
If your special circumstance meets these criteria, you must request approval to ship to a
pick-up station rather than to the patient using the request form that is available on our
website

Ohio Board of Pharmacy Discusses Basic Differences Between Manufacturing and Compounding Under Its Rules

Manufacturing Versus Compounding: 
Basic Differences
Manufacturing and compounding are two very different 
practices that are regulated differently as well. Ohio recognizes and 
enforces federal law that states compounding 
is performed by a pharmacist in a pharmacy and pursuant to a 
patient-specific prescription (refer to 21 USCA 
353a). Manufacturing does not require a patient-specific 
prescription, but requires a manufacturing license from
FDA that enables the company to produce and sell manufactured medications 
(typically in bulk) again without a 
patient-specific prescription. To obtain an FDA manufacturing license, 
the manufacturing site must also pass 
stringent quality assurance standards (good manufacturing practice) 
designed to test manufacturing of sterile 
drug product. Thus, there is much more scrutiny placed 
on this type of practice (manufacturing) typically due to 
the large amounts of drug product being made for resale. 
Medication compounding, on the other hand, involves 
the practice of taking commercially available products 
and modifying them to meet the unique needs of an individual
 patient pursuant to a prescription from a licensed 
provider. Our state law defines compounding in Ohio 
Revised Code 4729.01(C). Also, a pharmacy must follow 
the compounding requirements pursuant to Ohio Administrative Code 
(OAC) Rules 4729-5-25, 4729-9-25, 4729-
9-21, and 4729-19; current professional compounding 
standards; and all applicable federal and state laws, rules, 
and regulations. As required by OAC 4729-19-04, for 
compounding sterile injectables, the Board would expect 
to see in your written policies and procedures adherence 
to United States Pharmacopeia (USP) Chapter 797 guidelines. 
These guidelines are differentiated by the severity/
risk of the type of products being compounded. The Board 
expects that you review and understand these guidelines 
to assess your practice prior to compounding sterile injectable
 prescriptions. For more information regarding 
the USP Chapter 797 compounding guidelines, visit www
.usp.org/store/products-services/usp-compounding. 
Compounding in Ohio does not require a special FDA 
manufacturing license and can be performed with no 
extra licenses other than those required by the Board 
for pharmacy practice (RPh license for the pharmacist 
to practice, a terminal distributor of dangerous drugs 
license for the location, and, if needed, a Drug Enforcement 
Administration license for controlled substances). 
No doubt, compounding is a legal and common practice 
in many Ohio pharmacies and brings incredible value to 
Ohio patients. However, make sure that your processes 
meet all standards for compounding and that you are not 
manufacturing as defined above. The Board has created 
a great compounding document for review, which can be 
accessed from the Board’s Web site at www.pharmacy
.ohio.gov. Click on the “Terminal Distributor (TDDD) Licenses”
 tab and then on the “Compounding in Ohio” link. 
Source found here

Ohio Board of Pharmacy Summary Suspension of NECC in October


New England Compounding Center
Update
As many of you know from the Board’s recent e-mail
blast, the Board announced the summary suspension of the
Ohio Terminal Distributor of Dangerous Drugs license for

the New England Compounding Center (NECC) located
in Framingham, MA, effective October 9, 2012.  The
Board has participated in discussions with the Ohio Department of Health
(ODH) and the investigation conducted by the Centers for Disease Control
and Prevention and
the United States Food and Drug Administration (FDA)
concerning NECC’s contaminated methylprednisolone
acetate injections. To date, these products have resulted
in a fungal meningitis outbreak that has affected people
in 19 states and caused 28 deaths nationwide. Prior to the
issuance of the summary suspension, the Board found that
there was clear and convincing evidence that the continuation of NECC’s
professional practice in Ohio presented
a danger of immediate and serious harm to others.
The contaminated methylprednisolone acetate injections were
administered to 425 people in Ohio. All of
these patients have been notified by ODH and as of this
writing, 14 Ohio patients have tested positive for the
fungal meningitis infection. To date, there have been no
deaths in Ohio from this contamination. It appears that
four clinics in Ohio received the affected methylprednisolone product.
These clinics were located in Cincinnati,
Columbus, and Marion, OH. The Board is additionally
conducting its own investigation. Due to the amount of
product that has been shipped from NECC into Ohio,
there is federal concern that NECC was manufacturing
products, not compounding medications.

Source found here




Sunday, October 28, 2012

Compounding pharmacies face greater scrutiny in Ohio


Staff Writer
Ohio is cracking down on pharmacies that custom-mix individualized prescriptions in the wake of a deadly fungal meningitis outbreak tied to a Massachusetts compounding pharmacy.
Statewide, 17 pharmacies are now specially designated as compounding sites, said Jesse L. Wimberly, spokesman and pharmacy inspector for the Ohio State Board of Pharmacy. Inspectors check pharmacies at least every three years, though they will go more often if complaints are filed or violations are reported. “Now we’re going to every one of these pharmacies that are designated for compounding,” he said.
The state now requires pharmacies to spell out how much of their business is strictly retail sales and how much is mixing up custom preparations, Wimberly said. And when a state inspector comes to call, they have to be able to demonstrate both that their facilities meet cleanliness standards set out by the U.S. Pharmacopoeia, a kind of governing board for pharmacists, and to show that their products are being prepared for specific patients — not mixed up in advance and set aside so it’s ready when and if the order comes in.
“The issue we’re having now is are you doing patient-specific compounding,” Wimberly said. “We don’t do manufacturing. We do compounding for specific patients. We check the records and make sure that they’re in compliance so that when you get a prescription it’s for a specific person and you’re compounding that prescription for that person and giving that prescription to that person,” he said.
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