Showing posts with label Tennessee Board of Pharmacy. Show all posts
Showing posts with label Tennessee Board of Pharmacy. Show all posts

Tuesday, April 9, 2013

No timetable for Tenn. House vote on compounding bill


The Tennessee House has yet to schedule a vote on a bill approved by senators to allow providers to obtain compounded treatments during shortages without a patient-specific prescription. The state Department of Health acknowledges the hardship of balancing efforts to ease shortages with measures to ensure patient safety, said Dr. David Reagan, the state's chief medical officer. The measure is neither endorsed nor opposed by the department, Reagan said.
Source found here

Thursday, March 14, 2013

TN board moves toward new rules on compounding pharmacies


Tennessee pharmacies that compound medicine could see more inspectors more often under proposals the state pharmacy board set into motion Wednesday.
To do that, the board would beef up its inspection staff and pay for it by increasing licensing fees for all pharmacists and pharmacies.
The board told its staff to draft rules implementing those and other potential changes for its review, possibly as early as May. It’s unclear which proposals will become reality and when, as the rule-making process can last several months or longer.
“We have made progress,” board member Nina Smothers, a pharmacist, said following the nearly 4½-hour meeting.
Continue reading here

Sunday, February 10, 2013

TN Health Department won't disclose info on compounding lab inspections Agency cites state law for refusing to release information


The state Department of Health says it has stepped up inspections of sterile compounding pharmacies in Tennessee after a fungal meningitis outbreak tied to a tainted drug, but it won’t release the results.
Citing a state law, the agency has refused to state the number of violations cited, to say how many corrective actions have been taken, to release individual disciplinary reports against pharmacies or to specify the dates of their last inspections — the same type of information that the agency has released for hospitals, hospices, assisted living centers and nursing homes.
Read more here

Wednesday, January 23, 2013

Tennessee Task Force Reviews State's Compounding Pharmacy Regulations

 Topics: Compounding

The Tennessee Board of Pharmacy has convened a task force to review the state’s regulations pertaining to compounding and determine how regulations might be strengthened to further protect the public health. At the end of 2012, the Board conducted a survey of the 2,350 pharmacies licensed by the state. Of the 1,893 pharmacies responding, 352 indicated that they engage in sterile compounding, with 65 preparing more than 100 doses per day, reports The Tennessean. The task force is considering amending pharmacy compounding regulations, such as possibly including United States Pharmacopeia (USP) Chapter 797 standards. Other new regulations being considered may require new state legislation. In a meeting of the task force, the importance of sharing information about enforcement actions with other state boards of pharmacy and Food and Drug Administration (FDA) was also discussed. 
Source found here


Thursday, January 17, 2013

TN pharmacy board learning wide scope of licensed compounding in state Pharmacy Board learning of scope


The Tennessee Board of Pharmacy on Wednesday learned for the first time how widespread the practice of sterile compounding is across the state as it considers additional regulations of the industry.


According to preliminary survey results disclosed to the board at its meeting, 352 pharmacies licensed in Tennessee practice sterile compounding. The mandatory survey was prepared late last year after the national meningitis outbreak that has taken a heavy toll in Tennessee.
So far, 44 people nationwide, including 14 Tennesseans, have died after contracting a rare form of fungal meningitis. The infections came from tainted steroids prepared at New England Compounding Center in Massachusetts.
In response to the outbreak, the pharmacy board created a task force to study the state’s compounding regulations and how oversight could be improved. Compounding involves combining multiple medications to fill prescriptions for specific patients. Often the practice requires sterile conditions to prepare the prescriptions.
Late last year, the board sent surveys to 2,350 facilities licensed in Tennessee. Of the 1,893 that responded, 352 stated they conduct sterile compounding. Of that group, 65 prepare more than 100 doses of sterile drugs daily. Nearly 500 facilities have not yet responded to the survey, so the number could grow.
“The issue is if it’s that wide — and those who didn’t respond are the ones you especially want to worry about — that is a lot of pharmacies involved in this,” said public health expert Dr. Diana Zuckerman, who is president of the National Research Center for Women and Families.

Oversight studied

The pharmacy board is considering recommendations for state legislation that would create new regulations for sterile compounders.
However, board member Nina Smothers, who is leading the task force, said other improvements could be made administratively. For instance, Smothers said, the board could improve oversight by ensuring its inspectors were properly trained in how to inspect compounding pharmacies.
Smothers said adopting the U.S. Pharmacopeia’s model compounding regulations, which are called USP 797, is one possibility. USP 797 was created by the U.S. Pharmacopeial Convention, a nonprofit scientific organization that sets the national standard regarding the strength and purity of medications.
USP 797, which has been adopted in 18 states, provides guidelines for how pharmacists should prepare and handle compounded drugs.

Funding, training

Smothers’ task force also concluded that communication among Tennessee’s board of pharmacy, pharmacy boards in other states and the Food and Drug Administration regarding disciplinary action could improve.
The Tennessee Pharmacists Association’s executive director, Baeteena Black, told the pharmacy board that current laws are generally sufficient but instead the board should be adequately funded, its inspectors properly trained and out-of-state compounding facilities required to comply with state laws.
The board, which is mostly funded by licensure fees paid by pharmacists, has just five inspectors for 1,905 pharmacies and 706 manufacturers, wholesalers and distributors.
Contact Nate Rau at 615-259-8094 or nrau@tennessean.com. Follow him on Twitter @tnnaterau.
Source found here

Friday, January 4, 2013

Tennessee Board of Pharmacy Reminds Pharmacies of Difference Between Compounding and Manufacturing

Board Rules for Compounding Reemphasized
In the wake of the tragic events causing harm and loss of life across
the country, including several deaths in Tennessee, due to the fungal
meningitis outbreak, it is important to review the current definitions
and rules for Tennessee-licensed pharmacies practicing the art of
compounding. 
To start this discussion, it is important to understand the difference
between compounding and manufacturing. Refer to the following
definitions:
Tennessee Code Ann. §63-10-204 Definitions.
(4) “Compounding” means the preparation, mixing, assembling, packaging or labeling of a drug or device:
(A) As the result of a prescription order or initiative based on
the prescriber-patient-pharmacist relationship in the course
of professional practice;
(B) In anticipation of prescription orders based on routine,
regularly observed prescribing patterns; or
(C) For the purpose of, or as an incident to, research, teaching
or chemical analysis and not for sale or dispensing;
(12) “Dispense” means preparing, packaging, compounding or labeling for delivery and actual delivery of a
prescription drug, nonprescription drug or device in the
course of professional practice to a patient or the patient’s
agent by or pursuant to the lawful order of a prescriber;
(21) “Manufacturer” means any person, except a pharmacist
compounding in the normal course of professional practice,
engaged in the commercial production, preparation, propagation, conversion or processing of a drug, either directly or
indirectly, by extraction from substances of natural origin or
independently by means of chemical synthesis, or both, and
includes any packaging or repackaging of a drug or the labeling
or relabeling of its container and the promotion and marketing
of such drugs or devices;
(13) “Distribute” means the delivery of a drug or device, other
than by administering or dispensing, to persons other than the
patient or the patient’s agent;
Therefore, be advised that the patient-specific prescription via the
prescriber-patient-pharmacist (also known as the three-legged stool)
is required for the pharmacist to prepare and dispense a compounded
prescription.
To sell a manufactured drug without a prescription in Tennessee, (ie, office or hospital use) a wholesaler/manufacturer/distributor
(W/M/D) license, issued by the Tennessee Board of Pharmacy, is
required as discussed in the July 27-28, 2011 Board meeting minutes:
A company with the business model of providing admixture
pharmacy services, appeared before the board to ask for permission to operate as a pharmacy in Tennessee. The representative
explained that the company would compound sterile preparation in anticipation of institutional pharmacies’ prescription
orders and it would be based on the institution prescriber’s
routine prescribing patterns. The compounded admixture is
not patient specific but the company would like to send the
admixture to institutions based on past usage of the product.
After discussion, a member of the Board made the motion that
based on the business model discussed with this company, it
would be necessary that they be licensed in Tennessee as a
manufacturer/wholesaler/distributor. Furthermore, the motion
stated that if they decided to dispense patient specific, they
would have to be licensed as a pharmacy as well. The motion
was seconded and carried.
Currently, there are pharmacies licensed by the Board that carry
both W/M/D and pharmacy licenses. However, be advised that Food
and Drug Administration and Drug Enforcement Administration
(DEA) regulations may require licensure or other certifications to also
manufacture drug products for sale, purchase, or transfer.
For pharmacists practicing the art of sterile compounding under a
pharmacy license for patient-specific prescriptions, it is advised
to review the current Tennessee Board of Pharmacy rules found at
the following Web link: www.state.tn.us/sos/rules/1140/1140-07
.pdf. Board rules require documentation to be completed and readily
available, including flow hood certification, pre-filter records, training,
and policies and procedures
http://health.state.tn.us/Boards/Pharmacy/index.shtml
December  2012

Saturday, November 17, 2012

Tennessee Board of Pharmacy October 23, 2012 Meeting Regarding Surrender of Barry Cadden's License


A teleconference was held to review and discuss the volunteer surrender of Tennessee
pharmacist license #22971 for Barry James Cadden, D.Ph. Dr. Cadden is the pharmacist in
charge for New England Compounding Center and has been charged with violating T.C.A § 4-5-
3205(c) and board rule 1140-01-.06.
Dr. Warren called the meeting to order and to ensure that each participant was connected a roll
call vote was taken.  Dr. Eidson made the motion to proceed with the meeting electronically. Dr.
Kizer seconded the motion. The motion carried with a roll call vote.  Mr. Smith informed the
board of the need  for a motion to determine if the matter or matters to be discussed meet the
following requirements; the subject matters requires timely action, the physical presence of all
members is not possible and the participation by some or all of the members of the board by
electronic or other means is necessary. Ms. McDaniel made the motion that this meeting does
meet the requirements listed. Dr. Kizer seconded the motion. The motion carried with a roll call
vote.
Mr. Smith informed the board that Dr. Barry James Cadden has signed an Agreed Order to
voluntarily surrender his license and Dr. Cadden understands that this action is considered a
revocation and will be reported to the national database. Dr. Eidson asked for clarification of
board rule 1140-01-.06 listed as number 5 in the Consent Order under Stipulation of Fact. Mr.
Smith stated that this was not summary suspension but listed that rule as a notice that the board
could have preceded with a summary suspension. Dr. Eidson asked what are the difference in Tennessee Board of Pharmacy
Board Meeting
October 23, 2012
2
this order and the consent order signed by New England Compounding Center. Mr. Smith stated
that the differences include that New England Compounding Center consent order was based on
an inspection report by the Massachusetts Board of Pharmacy and the sterility of certain drug
products compounded and dispensed by the pharmacy, specifically methylprednisolone acetate
and Dr. Cadden paragraph three states that “On or about October 3, 2012, NECC voluntarily
surrendered its pharmacy license in its home state of Massachusetts. NECC’s Surrender
Agreement states that it relates to an inspection conducted on October 2, 2012.
Ms. McDaniel asked if the Department of Agriculture is the group that tags the vials and does the
investigation or if the Department of Agriculture is working with the Department of Health for
the collection of the medication sent from New England Compounding Center since the
Department of Agriculture is responsible by statute. Dr. Holt stated that the collection of the
medication is being directed by Commissioner Dreyzehner as part of the investigation and that
he doesn’t know if they are working with the Department of Agriculture or not. Ms. Young
stated that the Tennessee Food, Drug and Cosmetic Act which deals with adulterated drugs is
administered by the Department of Agriculture, and that the collection of the medication is not
part of this consent order. Ms. McDaniel asked how many vials have been shipped into
Tennessee. Ms. Young stated that the coordination on the public health end with the collection of
suspect drugs is being handled by the FDA, New England Compounding Center and the
Tennessee Department of Health Epidemiologist. They are trying to determine which product
was contaminated and how many patients were exposed to the product. Ms. Young stated that
she doesn’t believe that an investigation has been started on the pharmaceutical stand point but
that they are trying to complete the investigation as it pertains to the public health, safety and
welfare to the citizens of Tennessee. Ms. McDaniel stated that the reason she was asking about
the number of vials sent into Tennessee is that she is ready to assess a civil penalty to the
pharmacist today. Mr. Smith explained that a civil penalty cannot be assessed today because a
hearing would have to be scheduled and proof shown of the number of contaminated drugs and
the number of victims are not fully known at this time. Mr. Smith stated that Dr. Cadden would
be given the right to present proof of his own, but he cannot submit proof of the revocation of his
license and has no right to appeal this part of the order. Dr. Cadden can submit proof if the board
decides to have a hearing concerning the assessment of penalties. Ms. McDaniel asked Dr. Holt
about the process in which the Board of Pharmacy asses penalties during the regular course of
business through the compliant summary report. Dr. Holt stated that they complainant can appeal
the penalty. Ms. Young states that individuals that have agreed to the assessment of penalties
were due to the negotiation between them, their attorney if they have one, and the Office of
General Counsel and would result to a Consent Order. If the individual chooses not to accept the
Consent Order then the next phase is to file Notice of Charges for a hearing before the board.
Ms. Young stated that with respect to the board of pharmacy, many individuals agree to the
assessment of penalties and do not contest. Ms. McDaniel stated that the board had assessed a
fine on someone and they wanted to negotiate the fine and that this was done before a Consent
Order was issued. Ms. McDaniel stated that during the normal course of a board meeting the
board has assessed the penalty upfront and then we send the Consent Order. Ms. Young stated
that when a complaint has been filed with the board of pharmacy that the complaint is givien to
the board in an anonymous manner with the facts. The board will make a recommendation based
on the facts presented. Once the recommendation has been voted on the Office of General Tennessee Board of Pharmacy
Board Meeting
October 23, 2012
3
Counsel will prepare a Consent Order to send to the respondent and the respondent has the right
to sign the Consent Order and pay the penalty or request a hearing. Ms. McDaniel asked why we
cannot assess the penalty today and give Dr. Cadden the right to agree or disagree. Ms. Young
stated that the difference is that we know who the order is for and this was not a normal
complaint that came into the office anonymously. This order was generated by information given
by the media and the general public. Ms. Young also stated that Dr. Cadden has agreed to the
surrender of his license, not a penalty, and that the board cannot assess a penalty at this time. Dr.
Eidson asked about the Food, Drug and Cosmetic Act and that Ms. Young did not think that
these drugs were adulterated but according to T.C.A. § 53-1-108 (1)(A) which states that “A
drug or device shall be deemed to be adulterated if it consists, in whole or in part, of any filthy,
putrid or decomposed substance”. Ms. Young stated that she wouldn’t disagree if the facts were
proven and that we don’t have legal evidence to present at this point. Dr. Eidson stated that he is
concerned that the Department of Agriculture is not involved in the collection of the drugs and
that he would recommend that the Department of Agriculture get involved. Specifically that they
have authority to go get the contaminated drugs.  Ms. Young stated that she will take the
recommendation back to Commissioner Dreyzehner concerning the collection of the
contaminated drugs. Dr. Warren stated what she is hearing is that the board wants to make sure
that if there is any contaminated product still out in the general population that it has been
collected, removed from possibility of administration to patients, and tagged for future
investigations. Dr. Eidson stated that this was correct and that they would like to have the
number of contaminated vials that has been collected. Dr. Warren stated that the board would
like to have that number at the November board meeting.  Ms. McDaniel stated that she would
still like to recommend a civil penalty. Mr. Smith stated that they can recommend an assessment
of penalty but that the board cannot vote on it. The meeting was sunshined for the surrender of
Dr. Cadden’s Tennessee pharmacist license and the decision before the board is to accept the
Agreed Order or not.  After further discussion, Dr. Eidson made the motion to approve the
Agreed Order as presented for the volunteer surrender of Dr. Cadden’s pharmacist license and to
notify the other boards where Dr. Cadden has a valid pharmacist license. Ms. McDaniel
seconded the motion. The motion carried with a roll call vote. Dr. Eidson made the motion to
authorize Dr. Holt to sign the Agreed Order on behalf of the board. Ms. McDaniel seconded the
motion. The motion carried with a roll call vote. Dr. Eidson asked that the board delay the
discussion of assessing civil penalties until additional information has been received pertaining
to the number of vials sent to Tennessee by New England Compounding Center and how many
were contaminated.
Ms. McDaniel made the motion to adjourn at 11:00 a.m. Dr. Eidson seconded the motion. The
motion carried.
The minutes were approved and ratified at the November 14-15, 2012 board meeting.
Source found here

Tennessee Board of Pharmacy Action Against NECC

To view the voluntary surrender agreement click here

Friday, November 16, 2012

Sen. Lamar Alexander plans to introduce legislation in wake of meningitis outbreak


Published Friday, November 16th 2012
 Following a Senate hearing on the recent outbreak of fungal meningitis Thursday, Sen. Lamar Alexander praised the Tennessee Department of Public Health and called the Massachusetts State Board of Pharmacy "completely incompetent."
"This has been a nightmare for Tennesseans, as it has been for any Americans affected," Alexander said. "We've had 13 Tennesseans who have died, 81 Tennesseans are sick, a thousand more exposed. And all of us are shaken because we live in a country where we have this miracle that we walk into one of our 60,000 drugstores or pharmacies or we go to our doctor or a pain clinic and we get medicine—we don't think about it, we just assume it's safe."
Contaminated steroid injections packaged and distributed by a Massachusetts compounding center infected at least 461 persons with fungal meningitis nationwide, killing 32. Tennessee has reported more meningitis-related deaths than any other state.
During a conference call with reporters, Alexander said the quick actions of officials in the Tennessee Department of Health ultimately saved lives. The senator described the response as being "A-plus."
"Because they acted so rapidly, in just nine days they saved five or six lives and kept another 30 or so Tennesseans from becoming ill," he said.
Alexander, who said he expected to be the ranking Republican member of the Senate Health, Education, Labor and Pensions Committee next year, added that he will draft and introduce legislation immediately upon the convening of the next Congress.
"I'd like to make it the first order of business," he said.
A bill from Alexander will likely address the issue of shared responsibility for authorizing compounding facilities that is held between states and the U.S. Food and Drug Administration. The senator said he would prefer to have one entity overseeing the supervision of the nation's compounding pharmacies.
"Let's put either state boards of pharmacy or the FDA on the flagpole, and let the other get out of it," he said.
Source found here

Saturday, July 28, 2012

"Office Use" in Tennessee: Does this Apply to Compounded Drugs?


This article appeared in the Tennessee Board of Pharmacy January 2012 newsletter, which is found here:

Understanding the Correct Transfer for ‘Office Use’
Pharmacists have often asked how to follow the proper procedures
when transferring a medication to another pharmacy
or prescribing practitioner. Please note that the only place in
the Tennessee Board of Pharmacy rules that mentions “office
use” is in Rule 1140-06-.02 (5), which states “ . . . A nuclear
pharmacy practice site may also furnish radiopharmaceuticals
for office use to authorized practitioners for individual patient
use . . . ”
Therefore, what is allowed? Refer to Tennessee Board of
Pharmacy Rule 1140-09-.01, which states:
“ . . . (3) The requirement of a license [referring to a
Manufacturer/Wholesaler license] shall not apply to
the following types of distributions . . . [*](i) The sale,
purchase or trade of a prescription drug, or an offer
to sell, purchase or trade of a prescription drug by a
pharmacy practice site to another pharmacy practice
site or to authorized prescribing practitioners, except
that the total gross dollar volume of such transfers
shall not exceed five percent (5%) of the total medical and
prescription orders sales revenue of either the
transferor or transferee pharmacy during any twelve
(12) consecutive month period . . . ”
Therefore, instead of transferring pursuant to a prescription
for “office use only,” pharmacists are advised to invoice
the medication or medical device while complying with section (i),
and hold this readily retrievable record for two years.
In this manner, the medication can then be delivered to the
prescribing practitioner’s office or pharmacy.
Furthermore, the rules change/add when dealing with a
controlled substance. For a Schedule II medication, Drug
Enforcement Administration (DEA) Form 222 must be
completed between the seller and buyer, while one copy is
kept in the pharmacy for two years per Title 21, Code of
Federal Regulations (CFR) 1307.11, which may be found at
the following Web link: www.deadiversion.usdoj.gov/21cfr/
cfr/1307/1307_11.htm. An invoice with the following information
must also be kept for Scheduled III through V medication
including the name, address, and DEA registration number of
both parties, the name, strength, quantity, and dosage form of
the drugs, and the date of the transaction, pursuant to CFR
1304.22. CFR 1304.22 may be found at the following Web
link: www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_22.
htm. It is advised to obtain a signature of each registrant
on the invoice. This record must be kept for two years per
DEA CFR 1304.04., found at the following Web link: www
.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_04.htm.
According to CFR 1307.11, the pharmacy must make certain
that the distribution “. . . does not exceed 5% of total dosage
units of controlled drugs dispensed and distributed during the
same calendar year unless licensed as a distributor by DEA .
. . ” This regulation is in addition to the Tennessee Board of
Pharmacy rule stated previously, which refers to 5% of total
order sales revenue. (See asterisked section of Rule 1140-
09-.01 referenced at the beginning of this article.)

Tuesday, June 12, 2012

Tennessee Law Regarding Beyond-Use or Expiration Date on Compounded Drugs

Tennessee Board of Pharmacy recently reminded all pharmacy personnel of the state law requiring them to check compounding medications and ingredients that are past the beyond-use r expiration dates.

In its June 2012 newsletter found here, the Board stated:

Expired Medications Continue to Be Found on Pharmacy Shelves

As a reminder to all pharmacy personnel, it is advised to segregate all expired medications from stock, mark for destruction, and immediately destroy or return these items to a reverse distributor for destruction. Also, do not forget to check compounding medications and ingredients that are past the beyond-use or expiration date. Refer to Tennessee Board of Pharmacy Rule 1140-03-.11, which states:
The owner or pharmacist in charge of a pharmacy practice site shall immediately return or destroy all outdated, defective, or deteriorated prescription drugs and devices and related materials; except that the destruction of controlled substances listed in any schedule shall be performed by a board approved agent or vendor.

Historically, the Board has approved issuance of a letter of warning and/or civil penalties, depending on the facts associated with the violation.