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Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Showing posts with label Texas. Show all posts
Showing posts with label Texas. Show all posts
Friday, January 25, 2013
Texas Pharmacy Board Meeting Feb. 5, 2013 Agenda
Thursday, January 17, 2013
Texas Board Surveys Pharmacies About Compounding Practices, Will Seek Legislative Support for Additional Inspectors
Topics: Compounding
The Texas Board has in place compounding regulations that include most of United States Pharmaecopia (USP) Chapter 797 standards and some more detailed requirements not included in USP 797 (such as training for pharmacists and pharmacy technicians and specific recall procedures). In addition, the Board’s inspection process includes sampling compounded products for testing. The Board has the authority to sample both sterile and nonsterile products for testing. In Texas, nonsterile products are tested for potency, and sterile products are tested for potency, sterility, and pyrogenicity. Since the NECC incident, Texas has added testing for fungi to the requirements. Product samples are processed by an outside lab and the Board tracks data from the results. When a failure is detected, the Board will take action to resolve the issue with the pharmacy. Or, if testing were to determine that a product would be an imminent danger to the public, the Board would require the pharmacy to immediately recall the product and cease all compounding of that product. Of note, the Board has never had a product prepared under sterile conditions fail the sterility testing, including samples taken from entities compounding high volumes of drug products.
The Board indicates that there are currently pharmacies in Texas that compound products for distribution to out-of-state entities. The Texas Board has instructed inspectors to place a high priority on the inspection of all pharmacies that compound sterile products, including those that are distributing products to out-of-state entities. The Board has formed a task force to assist it in a thorough review of all of the laws and rules related to compounding and to make recommendations for changes to these rules and/or laws.
Source found here
Wednesday, January 16, 2013
Thursday, January 10, 2013
In Fight for Safe Compounding, a Salvo From NABP: 6 inspection done in 4 states--California, New Jersey, Texas and Utah--
by Bruce and Joan
Buckley
Inspectors from the National Association of Boards of Pharmacy (NABP) and
state pharmacy boards descended on six compounding pharmacies in four states
during the first two weeks of December as part of a broad, unified effort to
bolster the safety of customized medicines being shipped across state lines.
The inspections were carried out in California, New Jersey, Texas and Utah as public and political pressure for increased federal and state regulation of pharmacy compounders continued to mount in the wake of the fungal meningitis outbreak that, by mid-December, had sickened more than 650 individuals in 19 states and claimed nearly 40 lives.
The dual inspection campaign is set to continue well into 2013. It is part of the association’s contractual agreement with the Iowa State Board of Pharmacy to strengthen surveillance of compounding pharmacies licensed by Iowa but located outside its borders.
“We’re moving full bore ahead,” Carmen Catizone, MS, RPh, DPh, the executive director of the association, told Pharmacy Practice News. “The response from the states has been incredible. They’ve said, ‘This is an issue we own and we’re going to move quickly on it.’”
Preliminary findings from the inspections suggest that the New England Compounding Center (NECC), whose tainted methylprednisolone was the source of the meningitis outbreak, is by no means the only pharmacy to compound drugs that are seldom if ever tied to a specific prescription. Four of the six compounders were found to distribute non-patient-specific, preservative-free sterile injectables, which can be at odds with “traditional” compounding—that is, the preparation of medications prescribed in small quantities for specific individuals. Two of the pharmacies produced very large volumes of non-patient specific sterile drugs, Dr. Catizone reported.
The findings have been sent to Iowa, he said, and the state “is going to be making some determinations.” Dr. Catizone praised Iowa’s “innovative” initiative. “They were able to think outside the box and say, ‘We can’t hire staff to do this, but we have the funding and we can use it in a way that gets the outcomes accomplished.’” He said other states were weighing similar agreements with NABP.
The NABP approach—to preserve individual states’ ownership of traditional pharmacy compounding oversight while broadening their ability to monitor nonresident compounders who ship product into their states—appears to cross over into FDA turf, which is oversight of interstate-shipped medications.
The FDA, meanwhile, is pressing Congress for new legislation that will reinforce the agency’s hand in policing practices that go beyond prescription-driven compounding. But some pharmacy sources worry that the FDA’s push for new authority may threaten states’ traditional role and raise the risk for a possible “federalization” of compounding practice. “I am absolutely terrified that the FDA is going to get in the middle of this, and more importantly, I’m more afraid that Congress is going to get into the middle of this and they’re going to muck this thing up,” said Eric Kastango, RPh, MBA, the president and the CEO of Clinical IQ, speaking at the American Society of Health-System Pharmacists’ Midyear Clinical Meeting last month.
Others have raised doubts about whether a budget-minded Congress would allocate funds that the FDA needs to hire more inspectors and expand its national oversight of compounders. The FDA has moved to ease these concerns. In December, agency officials met with pharmacy and health department regulators from all 50 states to solicit input on how federal and state agencies might work together to “close gaps” in the “regulatory framework,” as Margaret Hamburg, MD, the FDA Commissioner, put it.
Pharmacy board officials who spoke at the two-hour FDA public hearing that followed their early meetings at the agency’s headquarters in Silver Spring, Md., expressed confidence in their capacity to regulate compounding pharmacies in their own states, but some said that they were challenged by the difficulty of controlling nonresident compounders. “We know what happens in pharmacies in Arkansas,” said John Clay Kirtley, PharmD, the executive director of the Arkansas State Board of Pharmacy. “We don’t necessarily know about what is happening in specific pharmacies in other states that ship into our state.”
Several board officials noted that insufficient funding often hampers states’ regulatory efforts. Jay Campbell, RPh, JD, the executive director of the North Carolina Board of Pharmacy, said that whereas his board and others in the Southeast region generally have the resources to carry out their missions, others around the country “are dealing with revenue challenges.” He said it was important for state lawmakers to recognize that pharmacy boards must be adequately funded “and not simply be viewed as a revenue stream” for general purposes.
Despite concerns about the potential for federal encroachment on what traditionally has been state regulatory terrain, some board officials saw areas where federal and state collaboration might prevent future public health calamities like the one caused by NECC. Cody Wiberg, PharmD, MS, RPh, the executive director of the Minnesota Board of Pharmacy, suggested that “joint investigations” by the FDA and state boards might be a way to ensure better enforcement of federal and state compounding standards. In most states, he said, pharmacy boards “are regulatory licensing agencies. We’re not law enforcement agencies. We can’t initiate criminal proceedings; the FDA can. In some of these really horrible situations, [that may] get the attention of folks even more” than separate actions by federal or state regulators alone, he noted.
At the federal level, Senate and House committees have launched investigations into the causes of the NECC disaster, laying the groundwork for legislative remedies later in 2013. At least two bills have been introduced in the House. The one gaining the most attention was initiated by Rep. Edward J. Markey (D-Mass.), in whose district NECC’s manufacturing facility is located. Under the bill, most compounding pharmacies that engage in mass production would be regulated by the FDA as drug manufacturers.
Continue reading here
The inspections were carried out in California, New Jersey, Texas and Utah as public and political pressure for increased federal and state regulation of pharmacy compounders continued to mount in the wake of the fungal meningitis outbreak that, by mid-December, had sickened more than 650 individuals in 19 states and claimed nearly 40 lives.
The dual inspection campaign is set to continue well into 2013. It is part of the association’s contractual agreement with the Iowa State Board of Pharmacy to strengthen surveillance of compounding pharmacies licensed by Iowa but located outside its borders.
“We’re moving full bore ahead,” Carmen Catizone, MS, RPh, DPh, the executive director of the association, told Pharmacy Practice News. “The response from the states has been incredible. They’ve said, ‘This is an issue we own and we’re going to move quickly on it.’”
Preliminary findings from the inspections suggest that the New England Compounding Center (NECC), whose tainted methylprednisolone was the source of the meningitis outbreak, is by no means the only pharmacy to compound drugs that are seldom if ever tied to a specific prescription. Four of the six compounders were found to distribute non-patient-specific, preservative-free sterile injectables, which can be at odds with “traditional” compounding—that is, the preparation of medications prescribed in small quantities for specific individuals. Two of the pharmacies produced very large volumes of non-patient specific sterile drugs, Dr. Catizone reported.
The findings have been sent to Iowa, he said, and the state “is going to be making some determinations.” Dr. Catizone praised Iowa’s “innovative” initiative. “They were able to think outside the box and say, ‘We can’t hire staff to do this, but we have the funding and we can use it in a way that gets the outcomes accomplished.’” He said other states were weighing similar agreements with NABP.
The NABP approach—to preserve individual states’ ownership of traditional pharmacy compounding oversight while broadening their ability to monitor nonresident compounders who ship product into their states—appears to cross over into FDA turf, which is oversight of interstate-shipped medications.
The FDA, meanwhile, is pressing Congress for new legislation that will reinforce the agency’s hand in policing practices that go beyond prescription-driven compounding. But some pharmacy sources worry that the FDA’s push for new authority may threaten states’ traditional role and raise the risk for a possible “federalization” of compounding practice. “I am absolutely terrified that the FDA is going to get in the middle of this, and more importantly, I’m more afraid that Congress is going to get into the middle of this and they’re going to muck this thing up,” said Eric Kastango, RPh, MBA, the president and the CEO of Clinical IQ, speaking at the American Society of Health-System Pharmacists’ Midyear Clinical Meeting last month.
Others have raised doubts about whether a budget-minded Congress would allocate funds that the FDA needs to hire more inspectors and expand its national oversight of compounders. The FDA has moved to ease these concerns. In December, agency officials met with pharmacy and health department regulators from all 50 states to solicit input on how federal and state agencies might work together to “close gaps” in the “regulatory framework,” as Margaret Hamburg, MD, the FDA Commissioner, put it.
Pharmacy board officials who spoke at the two-hour FDA public hearing that followed their early meetings at the agency’s headquarters in Silver Spring, Md., expressed confidence in their capacity to regulate compounding pharmacies in their own states, but some said that they were challenged by the difficulty of controlling nonresident compounders. “We know what happens in pharmacies in Arkansas,” said John Clay Kirtley, PharmD, the executive director of the Arkansas State Board of Pharmacy. “We don’t necessarily know about what is happening in specific pharmacies in other states that ship into our state.”
Several board officials noted that insufficient funding often hampers states’ regulatory efforts. Jay Campbell, RPh, JD, the executive director of the North Carolina Board of Pharmacy, said that whereas his board and others in the Southeast region generally have the resources to carry out their missions, others around the country “are dealing with revenue challenges.” He said it was important for state lawmakers to recognize that pharmacy boards must be adequately funded “and not simply be viewed as a revenue stream” for general purposes.
Despite concerns about the potential for federal encroachment on what traditionally has been state regulatory terrain, some board officials saw areas where federal and state collaboration might prevent future public health calamities like the one caused by NECC. Cody Wiberg, PharmD, MS, RPh, the executive director of the Minnesota Board of Pharmacy, suggested that “joint investigations” by the FDA and state boards might be a way to ensure better enforcement of federal and state compounding standards. In most states, he said, pharmacy boards “are regulatory licensing agencies. We’re not law enforcement agencies. We can’t initiate criminal proceedings; the FDA can. In some of these really horrible situations, [that may] get the attention of folks even more” than separate actions by federal or state regulators alone, he noted.
At the federal level, Senate and House committees have launched investigations into the causes of the NECC disaster, laying the groundwork for legislative remedies later in 2013. At least two bills have been introduced in the House. The one gaining the most attention was initiated by Rep. Edward J. Markey (D-Mass.), in whose district NECC’s manufacturing facility is located. Under the bill, most compounding pharmacies that engage in mass production would be regulated by the FDA as drug manufacturers.
Continue reading here
Saturday, December 15, 2012
Lack of Texas State Board of Pharmacy Inspectors is Concerning
Compounding pharmacies are allowed to mix or combine several drugs under sterile conditions for the purpose of treating specific patients’ needs; however, recently the sterility of compounding pharmacies has been questioned.
Because these pharmacies are not closely regulated by the FDA, individual states are responsible for regulations. But due to budget cuts, states like Texas have decreased the overall number of inspections of pharmacies while the number of Texas pharmacies has increased to an estimated 6,300. However, not all of these pharmacies are compounding pharmacies.
Texas, like most states, does not require pharmacies to have a separate registration if they compound medicine. The state pharmacy board doesn’t exactly know the number of facilities that mix medicine, which is concerning to officials in Texas and may bring about a better tracking system in the future.
Because the number of pharmacies in Texas has increased by 1,200 over the last ten years, it would make sense that the number of Texas State Board of Pharmacy inspectors would increase as well. However, the number of inspectors has remained at six, which means that even if each inspector inspected two pharmacies per day, they still wouldn’t be able to meet their goal of inspecting every pharmacy every two years.
Source found here
Thursday, November 8, 2012
Texas Board of Pharmacy Discussed Compounding at November 2012 Meeting
Agency Name: | Texas State Board of Pharmacy |
Date of Meeting: | 11/06/2012 |
Time of Meeting: | 9:00:00 AM (Local Time) |
Committee: | |
Status: | Active |
Street Location: | 333 Guadalupe Street, Suite 2-225 |
City Location: | Austin |
Meeting State: | TX |
TRD ID: | 2012007448 |
Submit Date: | 10/25/2012 |
Emergency Meeting?: | No |
Additional Information From: | Becky Damon, Executive Assistant 512-305-8026 Becky.Damon@tsbp.state.tx.us |
Agenda: |
A. Announcements
* Meeting Procedures
* Board Members
* Staff
* Continuing Education
B. Discussion and Approval of Minutes
* TSBP Board Business Meeting Held August 7, 2012
* Temporary Suspension Hearings
C. Discussion of and Possible Action Regarding Rules
C.1 Final Adoption of Rules
C.1.1 Amendments to §291.17 Concerning Inventory Requirements
C.1.2 Amendment to §291.74 Concerning Automated Devices and Systems
C.1.3 Amendments to §291.93 Concerning Labeling Prescriptions for Partner Therapy in Class D Pharmacies
C.1.4 Amendments to §291.104 Concerning Submission of Controlled Substance Prescription Information to the Texas Department of Public Safety by Class E Pharmacies
C.2 Proposal of Rules
C.2.1 Amendments to §291.31 Concerning Definitions
C.2.2 Amendments to §291.32 Concerning Personnel
C.2.3 Amendments to §295.8 Concerning Continuing Education Requirements
C.3 Rule Reviews in Accordance with Government Code, Section §2001.039
C.3.1 For Proposal
C.3.1.1 Chapter 297 Concerning Pharmacy Technicians (§§297.1-297.9)
C.3.1.2 Chapter 291 Concerning Pharmacies (Services Provided by Pharmacies(§§291.120-291.121, 291.123, 291.125, 291.127, 291.129, 291.131, 291.133)
D. Discussion of and Possible Action Concerning the Following Reports and Discussions
D.1 Financial Update
D.1.1 Review of FY2012 Expenditures
D.1.2 Review of Board Member Travel Budget
D.1.3 Update on Legislative Appropriations Request for FY2014-2015
D.2 Update Concerning Program to Aid Impaired Pharmacists and Pharmacy Students
D.2.1 Update on Number of Participating Individuals
D.2.2 Professional Recovery Network (PRN)
D.2.2.1 Presentation and Discussion Concerning PRN Expenditures and Activities by PRN Director Courtney Bolin
D.2.2.2 Review and Approval of Professional Recovery Network Program Audit
D.3 Discussion Concerning Problems With Sterile Compounding at an Out-of-State Compounding Pharmacy
D.4 Discussion Concerning Biosimilar Drug Products
D.5 Discussion Concerning Community Pharmacy Accreditation
D.6 Discussion Concerning Health Information Exchanges and/or Private Entities Maintaining Patient Records
D.7 Report on Appeals of Disciplinary Actions
D.8 Report on Dissemination of Information to Board Members Prior to Informal Conferences
D.9 Report on Shared Regulatory Data Base Project
D.10 Discussion Concerning Board Member E-Mail Addresses
D.11 Discussion of Possible Statutory Changes for Consideration During the 83rd Session of the Texas Legislature
E. Disciplinary Orders
E.1 Consideration of Proposals for Decision
E.1.1 In the Matter of Anne Akinyi Odim, Pharmacist License #40536
E.1.1.1 Executive Session Concerning the Proposal For Decision in the Matter of Anne Akinyi Odim, Pharmacist License #40536
E.2 Report on Agreed Board Orders Entered by Executive Director
E.3 Discussion of and Action on Proposed Agreed Board Orders and Default Orders
E.4 Executive Session to Consider Confidential Agreed Board Orders
F. Consideration of and Possible Action Concerning the Following Enforcement Reports
F.1 Consideration of Petition(s) to Serve as a Preceptor
F.1.1 Petition from Susan Nguyen-Thiem, R.Ph.
F.1.2 Petition from Joseph Adam Isbell, R.Ph.
F.1.3 Petition from Nancy Robin Duffle Golden, R.Ph.
F.1.4 Petition from Jaime Ponce Anaya, R.Ph.
F.2 Report on Complaints Closed and Dismissed During the Previous Quarter
F.3 Report on Status of Active/Pending Complaints
G. Miscellaneous
G.1 Items to be Placed on Agenda for February 2013 Board Meeting
G.2 Discussion of and Possible Action on Recent Conferences and Events
* National Association of Chain Drug Store (NACDS)
2012 Pharmacy & Technology Conference, Denver, CO
August 25-28, 2012
* Council on Licensure, Enforcement and Regulation (CLEAR)
Annual Education Conference, San Francisco, CA
September 6-8, 2012
* MALTA-GON
Annual Conference, Tulsa, OK
September 9-12, 2012
* Academy of Managed Care Pharmacy (AMCP)
Education Conference, Cincinnati, OH
October 3-5, 2012
* National Community Pharmacists Association (NCPA)
Annual Convention, San Diego, CA
October 13-17, 2012
* National Association of Board of Pharmacy/American
Association of Colleges of Pharmacy (NABP/ACCP)
District VI, VII, and VIII Annual Meeting, Little Rock, AR
October 21-24, 2012
G.3 Discussion of and Possible Action on Upcoming Conferences and Events
* Technician Informal Conference, Austin, November 28, 2012
(Mendoza)
* American Society of Consultant Pharmacists (ASCP)
Annual Meeting, National Harbor, MD
November 7-9, 2012
* Informal Conference, Austin, December 4-6, 2012
(Wiesner)
* Technician Informal Conference, Austin, December 13, 2012
(Stine)
* American Society of Health-System Pharmacists (ASHP)
Mid-Year Conference, Las Vegas, NV
December 2-6, 2012
* Informal Conference, Austin, January 8-10, 2013
(Tipton)
* Technician Informal Conference, Austin, January 24, 2013
(Stine)
__________
THE TEXAS STATE BOARD OF PHARMACY MAY ENTER EXECUTIVE SESSION TO CONSIDER ANY AGENDA ITEM WHEN PERMITTED BY TEXAS LAW.
Persons with disabilities who plan to attend this meeting and who may need auxiliary aids or services such as interpreters for persons who are deaf or hearing impaired, readers, large print or Braille, are requested to contact Cathy Stella at (Voice) 512/305-8000, (FAX) 512/305-8075, or TDD 1-800/735-2989. Requests for reasonable accommodations should be made five working days prior to the meeting so that appropriate arrangements can be made.
Sunday, September 2, 2012
Blue Cross Blue Shield of Texas: Information on Compounding
Introduction
Pharmacy Compounding is an ancient practice in which pharmacists combine, mix or alter ingredients to create unique medications that meet specific needs of individual patients. Compounding is a practice that continues to attract the scrutiny of the U.S Food and Drug Administration (FDA) – mainly because of instances where compounded drugs have endangered public health.
The FDA considers virtually all compounded drugs as unapproved new drugs for which safety and efficacy have not been demonstrated with the type of data the FDA requires to approve a new drug. However, the FDA also considers "traditional compounding" to be a valuable service and does not take enforcement action against these practices. The FDA defines traditional compounding as customizing a drug for someone who is allergic to a dye or preservative in an FDA approved medicine, or compounding a liquid dosage form specifically for a younger patient, etc. Compounding does not generally include mixing or reconstituting commercial products in accordance with the manufacturer’s instructions or the product’s approved labeling.
Red Flags and Enforcement Activities by the FDA
The emergence over the past 10-15 years of firms with pharmacy licenses making and distributing unapproved new drugs in a way that is clearly outside the bounds of traditional pharmacy practice is of great concern to the FDA. FDA enforcement has been directed to those pharmacies whose activities raise the kinds of concerns normally associated with a drug manufacturer and whose compounding practices result in significant violations of the new drug, adulteration, or misbranding provisions of the federal Food, Drug, and Cosmetic Act (FDCA). In addition, unlike commercial drug manufacturers, pharmacies are not required to report adverse events associated with compounded drugs. In a May 2007 consumer newsletter, the FDA reported knowing of more than 200 adverse events involving 71 compounded products since 1990. Examples of some of these adverse events included: three deaths due to contaminated compounded intravenous solutions, and blinding of two patients as well as damaged eyesight to others from a bacterially contaminated compounded product used in cataract surgery. In a 2001 FDA survey of compounded drug products, the agency found 34% of the products tested failed standard quality tests (usually failing potency analyses) as opposed to a less than 2% failure rate for commercially produced drug samples. Examples of medications included in the testing sample included sterile injectables (e.g. dipyridamole, papaverine, phentolamine, etc.), pellet inplants (e.g. estradiol), ophthalmic solutions/ointments (e.g. ciprofloxacin, dexamethasone, timolol, etc.), inhalation (e.g. tobramycin), and oral products (e.g. progesterone, estradiol, etc.). As a consequence, the FDA has issued a number of warning letters to pharmacies that specialize in female hormone products (e.g. ‘Bioidentical hormone replacement therapies’), anti-infective inhalation products, sustained-release/delayed-release/extended-release products, and local anesthetic pain products. FDA Warning Letters have also been sent in cases where the FDA believes pharmacy communications (e.g. advertisements, website information, etc.) contain false and misleading claims about product safety, effectiveness, and superiority to FDA approved and commercially available products. When contemplating further action against compounding pharmacies the FDA considers whether the pharmacy engages in the following acts:
- Compounding drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions.
- Compounding drugs that were withdrawn or removed from the market for safety reasons.
- Compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs (e.g. estriol) without an FDA sanctioned investigational new drug application (IND).
- Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA registered facility.
- Receiving, storing, or using drug components not guaranteed or otherwise determined to meet official compendia requirements.
- Using commercial scale manufacturing or testing equipment for compounded drug products.
- Compounding drugs for third parties who resell to individual patients or offering compounded drug products at wholesale to other state licensed persons or commercial entities for resale.
- Compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products. In certain circumstances, it may be appropriate for a pharmacist to compound a small quantity of a drug that is only slightly different than an FDA-approved drug that is commercially available. In these circumstances, FDA will consider whether there is documentation of the medical need for the particular variation of the compound for the particular patient.
- Failing to operate in compliance with applicable state law regulating the practice of pharmacy.
Saturday, September 1, 2012
The New Texas Health Care Privacy Law (HB 300) and HIPAA/HITECH Compliance: What You Need To Know Now
Registration
Schedule:
Wednesday, September 26, 2012
12PM CENTRAL
(1:00 ET / 10:00 PT / 11:00 MT )
Duration: 60 minutes
$45 for Members
$70 for Non-members
Already Registered?
Refer to confirmation e-mail for connection instructions.
Wednesday, September 26, 2012
12PM CENTRAL
(1:00 ET / 10:00 PT / 11:00 MT )
Duration: 60 minutes
$45 for Members
$70 for Non-members
Already Registered?
Refer to confirmation e-mail for connection instructions.
Tell a Colleague!
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If you're unable to find the answer you need, please call 800-701-5161 (M-F, 8am-6pm CT) or e-mail customer service
Summary
For more information on this seiminar click here.
This lesson is a knowledge-based CE activity and is targeted to pharmacists and technicians. This program has been approved for 1.0 contact hours of continuing education credit (0.1 CEUs).
Texas Pharmacy Association (154) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program has been assigned ACPE number 0154-0000-12-012-L03 and is accredited for 1.0 Contact Hours (0.1 CEUs).
Description: This program will cover existing Texas privacy laws and information on the new legislation.
At the completion of this program, pharmacists and technicians will be able to:
Texas Pharmacy Association (154) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program has been assigned ACPE number 0154-0000-12-012-L03 and is accredited for 1.0 Contact Hours (0.1 CEUs).
Description: This program will cover existing Texas privacy laws and information on the new legislation.
At the completion of this program, pharmacists and technicians will be able to:
- Identify the key components and requirements of HIPAA and the new Texas health care privacy law for Texas pharmacists, pharmacy technicians, pharmacies and other Texas entities.
- Appraise the significance of pharmacy accountability and potential enforcement, audit, and civil penalty consequences for privacy breaches.
- Comply with federal and state privacy and security laws, regulations and rules for the protection of identifiable protected health information.
Texas Pharmacy Association Pharmacy Law Symposium
Texas Pharmacy Association
presents:
Texas Pharmacy Law Symposium
This program is for pharmacists.
This program is aimed at giving pharmacy professionals a better understanding of Texas and Federal drug laws. Students & reciprocating pharmacists should take this program to prepare for the state law exam.
When:Saturday - February 16, 2013
Where: Texas Association of School Boards (TASB) Building, 12007 Research Blvd., Austin, TX 78759
CLICK HERE to view a list of area hotels.
If you need to take the course prior to this date, click here to view TPA's online Texas Pharmacy Law Symposium.
Where: Texas Association of School Boards (TASB) Building, 12007 Research Blvd., Austin, TX 78759
CLICK HERE to view a list of area hotels.
If you need to take the course prior to this date, click here to view TPA's online Texas Pharmacy Law Symposium.
Learning Objectives:
Upon completion of this program, participant will be able to:
Upon completion of this program, participant will be able to:
1. Identify the major provisions of the federal Food, Drug and Cosmetic Act that relate to the practice of pharmacy.
2. Compare and contrast the requirements of the federal Controlled Substances Act and theTexas Controlled Substances Act.
3. Distinguish between dispensing and distribution of controlled substances and the record-keeping requirements for each.
4. Describe the legal requirements for dispensing prescriptions for controlled substances, dangerous drugs and non-prescription medicines.
5. Explain theTexas Drug Product Substitution Act.
6. Explain the requirements for pharmacist and pharmacy licenses inTexas .
2. Compare and contrast the requirements of the federal Controlled Substances Act and the
3. Distinguish between dispensing and distribution of controlled substances and the record-keeping requirements for each.
4. Describe the legal requirements for dispensing prescriptions for controlled substances, dangerous drugs and non-prescription medicines.
5. Explain the
6. Explain the requirements for pharmacist and pharmacy licenses in
Agenda:
8:00 a.m. – 12:00 p.m.: Law Review programFor more information, click here.
12:00 p.m. – 1:00 p.m.: Lunch break
1:00 p.m. – 5:30 p.m.: Law Review program / Q&A
Saturday, August 25, 2012
Warning Letter to Sogeval Laboratories in Coppell, TX
March 13, 2012
2012-DAL-UTL-15
CERTIFIED MAIL:
RETURN RECEIPT REQUESTED
Thomas L. Bell, President and CEO
Sogeval Laboratories, Inc.
635 Fritz Drive, Suite 210
Coppell, TX 75019
Dear Mr. Bell:
During the May 9 through 20, 2011, inspection of your establishment at 635 Fritz Drive, Suite 210, Coppell, Texas, an investigator from the Food and Drug Administration determined that your firm is an own-label distributor of veterinary drug products. These products are drugs within the meaning of section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1)(B) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
The above-stated inspection revealed that your firm's veterinary drugs are adulterated under section 501(a)(2)(B) of the Act, 21 U.S.C. § 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packaging or holding fails to conform to, or is not operated or administered in conformity with Current Good Manufacturing Practice (CGMP) regulations as specified in Title 21, Code of Federal Regulations, Parts 210 and 211 (21 C.F.R Parts 210 and 211). No distinction is made between animal and human drugs, and the failure to comply with CGMP constitutes a failure to comply with the requirements of the Act.
In addition, our October 11 to November 4, 2011 inspection at Sogeval Laboratories, Incorporated, located at 4027 Tampa Road, Suite 3000, Oldsmar, Florida, identified numerous additional CGMP violations.
Please note that we have reviewed Ms. Lemaire's response dated June 2, 2011 in response to FDA's May 2011 inspection at Coppell, Texas and November 22, 2011 in response to FDA's October inspection in Oldsmar, Florida. We have included applicable comments following each item listed below.
The Coppell location
CGMP violations
Your firm distributes under its own label, drug products that are
manufactured for you by contract manufacturers. Your firm has responsibility for
complaint handling and additional quality control unit (QCU) functions. Your
firm's operations must satisfy the requirements of 21 C.F.R. §§ 211.198 and
211.22, but fail to do so. Specifically,1. Your firm's QCU failed to ensure a thorough investigation in accordance with 21 C.F.R. § 211.192 with conclusions and follow up accomplished as required by 21 C.F.R. § 211.198(a).
For example, the QCU failed to investigate or did not fully investigate complaints in numerous documented instances. Specifically, nineteen (19) consumer complaints were received by your firm from July 2009 to May 2011, for DUOXO Microcellular Cleaning Solution, DUOXO Spot-on, DUOXO Microcellular Solution, DUOXO Seborrhea Shampoo, and DOUXO Calm Emulsion Spray. The complaints included: animal ruptured ear drum, animal skin reactions, respiratory distress in humans, and a related human death. We have concluded your company did not conduct timely, comprehensive investigations. Your firm's management, including the QCU, was not proactive in response to consumer complaints. Quality problems must be thoroughly investigated, root cause determined, and appropriate corrective and preventive actions implemented. Furthermore, your firm does not have a written procedure for conducting investigations when complaints are received. We acknowledge your commitment to develop an SOP for complaint handling; however, your response is inadequate because you do not define a timeframe for completion or define what will be further developed in the SOP.
2. Your firm has failed to follow written responsibilities and procedures applicable to the QCU [21 C.F.R. § 211.22(d)].
Your firm does not have documentation addressing the basic roles, responsibilities, and procedures for your QCU. We acknowledge your commitment to develop an SOP to define the scope of responsibilities of the QCU; however, your response is inadequate because it fails to 1) describe changes that would be implemented in your procedures in the Quality Manual to ensure an effective QC process and, 2) include any analysis of the effectiveness of your procedure. We cannot assess the adequacy of the above corrective actions since the SOPs have not been submitted.
3. The QCU has not fulfilled its responsibility nor exercised its authority to approve or reject drug products manufactured, processed, packed, or held under contract by another company [21 C.F.R. § 211.22(a)].
For example, your firm has been an own-label distributor for contract manufactured veterinary drug products since 2008. However, only two audits have been conducted of these contract manufacturing firms since that time. Our inspection raises concerns about the effectiveness of the audits. Please comment on how future audits will ensure the QCU will identify and correct deficiencies and prevent recurrences. Further, your firm should have agreements in place with your contract manufacturers. We are also concerned about your firm's fundamental understanding of what is required of your QCU and the regulatory expectations to handle specific agreements that delineate responsibilities to each party (e.g., quality control responsibilities). Your firm is ultimately responsible for the quality of your products. Regardless of who manufactures your products, you are required to ensure these products meet predefined specifications prior to distribution and are manufactured in accordance with the Act, and its implementing regulations, including CGMP regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Part 211.
The Oldsmar facility
CGMP violations
1. Your firm's QCU failed to ensure a thorough investigation in accordance
with 21 C.F.R. § 211.192 with conclusions and follow up accomplished as required
by 21 C.F.R. § 211.198(a).For example,
a) Your firm failed to adequately investigate Adverse Event #2011-054, dated July 12, 2011, regarding human suffering an adverse reaction (asthmatic attacks) allegedly involving use of DOUXO Chlorhexidine PS Shampoo, lot# 003404.
b) Your firm failed to adequately investigate Adverse Event #2011-053, dated July 25, 2011, regarding human suffering adverse reaction (hives, breathing problems) allegedly involving use of PhytoVet P Anti-Itch Shampoo, lot #10911A.
c) Your firm conducted a recall of DOUXO Calm Shampoo 3L, lot # 006901, Exp 09/12, after product complaint of foul odor, dated September 1, 2011. A retain sample of this lot revealed microbial growth. However, no action was taken to determine cause of the microbial growth.
We have concluded that your company did not conduct timely, comprehensive investigations to numerous adverse events received at your distribution facility. Each investigation should include a root cause determination, corrective action plan, and evaluation of product impact.
We acknowledge in your response that you plan to further develop a new SOP for complaint investigation. However, your response is inadequate because you do not define a timeframe for completion or define what will be further developed in the SOP.
2. Your firm's written procedures to control issuance of labels are incomplete [21 C.F.R. § 211.125(f)] and your firm failed to conduct reconciliation between labels issued, used, and returned and product produced [21 C.F.R. § 211.125(c)].
For example,
a) Your firm's Labeling Control Procedure, SOP-OP501.01TR-R01-15-11, lacks information regarding control of issuance of labeling to drug product labeling operations.
b) Your firm does not document: 1) the quantity of labels issued to or returned unused from the production floor, 2) quantity of labels obtained for use or returned unused by each employee or for each production line and, 3) differences in quantity of labels found after (b)(4) inventory.
Your response stated the SOP will be revised to include label issuance details; however, the response failed to include what specific details will be included in the updated SOP. Furthermore, your response did not include the revised SOP.
3. Your firm has failed to follow written responsibilities and procedures applicable to the QCU [21 C.F.R. § 211.22(d)].
Your firm does not have documentation addressing the basic roles, responsibilities, and procedures for your QCU. We acknowledge your commitment to develop an SOP to define the scope of responsibilities of the QCU; however, your response is inadequate because it fails to 1) describe changes that would be implemented in your procedures in the Quality Manual to ensure an effective QC process and, 2) include any analysis of the effectiveness of your procedure. We cannot assess the adequacy of the above corrective actions since the SOPs have not been submitted.
Be advised that we will confirm the implementation and adequacy of all corrective actions upon reinspection of your facilities.
Neither this letter nor the observations noted in this letter are intended to be an all inclusive statement of deficiencies that may exist at your facilities. It is your responsibility to ensure that all facilities under your control comply with all of the requirements of the Act and the regulations promulgated under it.
We remind you that under Section 512 of the Act, 21
U.S.C. 360b, to be legally marketed new animal drugs require approved or
conditionally approved new animal drug applications, approved abbreviated new
animal drug applications, listings on the Index of Legally Marketed Unapproved
New Animal Drugs for Minor Species (Index Listings), or investigational
exemptions. We note that your firm markets its topical drug products without
approved applications, index listings, or investigational exemptions. You should
be aware that unapproved products that lack a required application or index
listing are subject to FDA enforcement action to remove them from the market at
any time. We also remind you that all drugs, whether marketed with approval or
not, must, among other things, be listed with the FDA by a registered firm;
manufactured according to CGMP; and have labels and labeling that meet the
requirements of the Act and its implementing regulations. You may obtain
information on the drug application approval process on our web page www.fda.gov/cvm1.
Please notify this office in writing, within 30 working days of receipt of
this letter, of the specific steps that you have taken to correct the noted
violations, including an explanation of each step being taken to prevent the
recurrence of similar violations. If corrective actions cannot be completed
within 30 working days, state the reason for delay and provide timeframes or a
schedule detailing when these corrections will be completed.
Your reply should be sent to the Food and Drug
Administration, Dallas District Office, 4040 North Central Expressway, Suite
300, Dallas, Texas 75204, to the attention of Rose Ashley, Compliance Officer.
If you have any questions about the content of this letter please contact Rose
Ashley at (210) 541-9450, Ext. 1118 or email at Rose.Ashley@fda.hhs.gov.
Sincerely,/s/
Reynald R. Rodriguez, Jr.
Dallas District Director
RRR/rma
Friday, July 27, 2012
August Meeting Agenda of Texas Board of Pharmacy Includes Recall Procedure Amendments Again
To view the August 2012 agenda for the Texas Board of Pharmacy meeting, click here. On the agenda again in August for discussion are the amendments relating to the recall of compounded preparations
RULE ANALYSIS
Introduction: THESE AMENDMENTS ARE SUBMITTED TO THE BOARD FOR CONSIDERATION AS ADOPTED RULES
Short Title: Recall Procedures
Rule Numbers: §§291.131, 291.133
Statutory Authority: Texas Pharmacy Act, Chapter 551-566 and 568-569, Occupations Code:
(1) Section 551.002 specifies that the purpose of the Act is to protect the public through the effective control and regulation of the practice of pharmacy; and
(2) Section 554.051 gives the Board the authority to adopt rules for the proper administration and enforcement of the Act.
Purpose: The amendments, if adopted, clarify the requirements for the recall of compounded preparations.
Background: Board staff presents these recommendations to clarify the recall procedures for pharmacies compounding sterile and non-sterile preparations.
The Board reviewed and voted to propose the amendments during the May 8, 2012, meeting. The proposed amendments were published in the June 22, 2012, issue of the Texas Register at 37 TexReg 4523.
Sunday, July 8, 2012
New Rules in Texas Relating to Veterinary Compounding
The Texas State Board of Veterinary Medical Examiners have adopted rules impacting veterinarian compounding in Texas. A complete set of all the new rules adopted in Texas can be found here. The following rule was adopted in the Spring of 2012 and became effective June 14, 2012. The rules are intended to limit veterinarians from compounding significant quantities of drugs in advance of diagnosis for business profit reason without having established a veterinarian-client relationship for the patient and diagnosing a condition or disease in that patient. The adopted rule includes limitations on extralabel drug use in food-producing animals, based on federal regulations and is intended to parallel the requirements for compounded drugs. The new rule 573.44 provides:
Here are the boards comments, which can be found here, on that new rules:
22 TAC §573.44
RULE §573.45 EXTRA-LABEL OR OFF-LABEL USE OF DRUGS provides:
The board's comments about rule 573.45 are as follows.
RULE §573.44 COMPOUNDING DRUGS
(a) A veterinarian may only compound drugs for a specific animal or herd with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship.
(b) A veterinarian may only prescribe compounded drugs to treat a specific occurrence of a disease or condition, which threatens the health of the animal or will cause suffering or death if left untreated, that the veterinarian has observed and diagnosed in the particular patient for whom the compounded drugs are prescribed. The amount of a drug that a veterinarian compounds or orders compounded must not exceed the established need for specific compounded drugs for patients with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship.
(c) Labeling Requirements.
(1) All compounded drugs must bear the labeling information required under §573.40 of this title (relating to Labeling of Medications Dispensed), as well as the following information:
(A) date on which the drug was compounded;
(B) name and strength of medically active ingredients;
(C) identity of treated animals;
(D) withdrawal/withholding times if needed; and
(E) condition or disease to be treated.
(2) In addition to the information listed in paragraph (1) of this subsection, compounded drugs dispensed to the client must also state a date dispensed and an expiration date, which should not exceed the length of the prescribed treatment.
(d) Limitations on Compounded Products.
(1) A veterinarian shall not compound or order a drug compounded if there is a FDA-approved,
commercially available animal or human drug that, when used as labeled or in an extra-label fashion in its available dosage form and concentration, will appropriately treat the patient.
(2) A veterinarian shall only compound or order compounded products with FDA-approved commercially available animal or human drugs as the active ingredients.
(3) A veterinarian shall not promote and/or distribute compounded drugs that are essentially similar to FDAapproved products.
(4) A veterinarian must ensure the safety and efficacy of a compounded drug, including but not limited to avoiding known drug incompatibilities and inappropriate combinations, and must use a pharmacist to perform drug compounding when the complexity of the compounding exceeds the veterinarian's knowledge, skill, facilities, or available equipment.
(e) Compounding for Food Producing Animals.
(1) For animals intended for human consumption, a veterinarian must establish an extended withdrawal interval for the compounded product sufficient to ensure food safety and may not compound from any drugs prohibited for use in food producing animals. The withdrawal period must be supported by scientific information, and the veterinarian shall note the method used to determine the withdrawal interval in the patient records.
(2) A veterinarian shall not compound or order a drug compounded if the compounded drug results in
violative food residue, or any residue that may present a risk to public health.
(3) Compounding from a human drug for use in food-producing animals is not permitted if an approved animal drug can be used for compounding.
(4) Veterinarians shall ensure that procedures are in place to maintain the identity of treated animals, and shall note those procedures in the patient records.
(f) Limitations on Promotion and Sale of Compounded Drugs.
(1) A veterinarian shall not prepare for sale any compounded drugs which employ fanciful names or trade names, colorings or other additives, or that in any way imply that the compounds have some unique effectiveness or composition.
(2) A veterinarian shall not advertise, promote, display, resell, or in any other way market prepared
compounded drugs.
(3) A veterinarian shall not offer compounded drugs to other state licensed veterinarians, pharmacists or other commercial entities for resale.
Source Note: The provisions of this §573.44 adopted to be effective June 14, 2012, 37 TexReg 4229
Here are the boards comments, which can be found here, on that new rules:
22 TAC §573.44
The Board adopts new §573.44, regarding Compounding Drugs, which sets out the limited circumstances in which a veterinarian can compound a drug. The adopted new rule parallels current state and federal regulations on the compounding of drugs by veterinarians while emphasizing issues that are of particular significance for veterinarians, such as the importance of the veterinary-client-patient relationship and the limitations on drugs compounded for foodproducing animals. The adopted rule is structured by subject-area, to clarify the limitations that apply to all compounded products, the limitations on compounding for food producing animals, and the limitations on promotion and sale of compounded drugs. The new adopted rule strengthens the requirement that a veterinarian must establish and maintain a veterinarian-client
-patient relationship with any animal for which the veterinarian compounds drugs. The Board intends the adopted rule to limit drug compounding by veterinarians only to treat a specific occurrence of a disease or condition that the veterinarian has diagnosed in a specific patient, and to prohibit veterinarians from compounding on any other basis or in quantities greater than those needed for the treatment of the particular disease occurrence in the specific diagnosed patient. The Board's concern is that some veterinarians compound significant quantities of drugs in advance of diagnosis for business profit reasons without first diagnosing the condition or disease the compounded drug is designed to treat in a particular patient with whom the veterinarian has established and maintained a veterinarian-client-patient relationship. Compounding drugs for
office use is allowed under the rule, but only in amounts that do not exceed the established historical need for specific compounded drugs for patients with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship. The adopted rule includes more detailed provisions requiring that a veterinarian only compound products made with FDA-approved drugs as active ingredients, and not promote or distribute compounds that are essentially the same as other FDA-approved drugs. The subsection of the adopted rule regarding compounding for food-producing animals parallels existing federal and state law on the subject by requiring that the veterinarian set withdrawal times that are based on scientific
information and note the method used to determine the withdrawal period in the patient records, and ensure that procedures are in place to maintain the identity of any food-producing animal that receives a compounded drug. With regard to labeling requirements for compounded drugs, the new adopted rule eliminates redundancies in the labeling information required for all drugs under §573.44, and requires that the label for compounded drugs include both name and strength of medically active ingredients.
RULE §573.45 EXTRA-LABEL OR OFF-LABEL USE OF DRUGS provides:
(a) Extra-label or off-label use is the actual or intended use of a drug in an animal that is not in accordance with the approved labeling, and includes, but is not limited to:
(1) compounded drugs;
(2) use in species not listed in the labeling;
(3) use for diseases or other conditions not listed in the labeling;
(4) use at dosage levels, frequencies, or routes of administration other than those stated in the labeling; and
(5) deviation from the labeled withdrawal time based on these different uses.
(b) A veterinarian must use his or her discretion in the off-label use of drugs for animals. In exercising such discretion, a veterinarian shall consider, to the extent possible:
(1) whether the off-label use of a drug meets the community standard of humane care and treatment set out in §573.22 of this title (relating to Professional Standard of Care);
(2) the established safety of the off-label usage;
(3) the inclusion of a drug in a standard veterinary formulary;
(4) analyses of off-label usage in the veterinary medical literature and in articles and commentaries written by the veterinarian's peers in the veterinary medical profession;
(5) information provided by the drug's manufacturer, vendor or the FDA as to whether off-label usage of a drug may present a risk to public health; and
(6) any other sources of pertinent information
(c) If anticipated off-label use of a drug is not commonly accepted or used by average veterinarians in the community in which the veterinarian practices or if the off-label usage does not have an established safety record, the veterinarian shall orally or in writing inform the client that the off-label usage is not commonly accepted or used in the veterinary community and that such usage could pose a risk to the e health of the animal.
Any oral notification shall be recorded in the patient records.
(d) Extra-Label Drug Use in Food Producing Animals.
(1) For animals intended for human consumption, a veterinarian must establish an extended withdrawal interval sufficient to ensure food safety. The withdrawal period must be supported by scientific information, and the veterinarian shall note the method used to determine the withdrawal interval in the patient records.
(2) A veterinarian shall not prescribe an extra-label drug in a manner that will result in violative food residue, or any residue that may present a risk to public health.
(3) Veterinarians shall ensure that procedures are in place to maintain the identity of treated animals, and shall note those procedures in the patient records.
Source Note: The provisions of this §573.45 adopted to be effective June 14, 2012,
The board's comments about rule 573.45 are as follows.
22 TAC §573.45
The Board adopts new §573.45, regarding Extra-Label or Off-Label Use of Drugs, which sets out the conditions under which a veterinarian may prescribe a drug for an off-label use. The adopted new rule includes compounded drugs explicitly among the list of extra-label or offlabel uses for drugs. Although compounding is commonly considered an off-label use, some licensees have expressed confusion over whether the limitations on extra-label use applied to compounded drugs as well as approved drugs. The adopted rule includes limitations on extralabel drug use in food-producing animals, based on federal regulations and is intended to parallel the requirements for compounded drugs set out in adopted new §573.44.
Thursday, June 28, 2012
Texas State Board of Pharmacy Proposed Amendments
SUBCHAPTER G. SERVICES PROVIDED BY PHARMACIES
22 TAC §291.131, §291.133
The Texas State Board of Pharmacy proposes amendments to §291.131, concerning Pharmacies Compounding Non-Sterile Preparations, and §291.133, concerning Pharmacies Compounding Sterile Preparations. The proposed amendments, if adopted, clarify the requirements for the recall of compounded preparations.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rules are in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rules.
Ms. Dodson has determined that, for each year of the first five-year period the rules will be in effect, the public benefit anticipated as a result of enforcing the rules will be to ensure that the proper recall procedures are being practiced by pharmacies that are compounding sterile and non-sterile preparations. There is no fiscal impact for individuals, small or large businesses, or to other entities which are required to comply with these sections.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8008. Comments must be received by 5:00 p.m., July 31, 2012.
The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.131.Pharmacies Compounding Non-Sterile Preparations.
(a) - (c) (No change.)
(d) Operational Standards.
(1) - (6) (No change.)
(7) Drugs, components, and materials used in non-sterile compounding.
(A) - (H) (No change.)
(I) A pharmacy may not compound a preparation that contains ingredients appearing on a federal or state agency [Food and Drug
Administration ] list of drug products withdrawn or removed from the
market for safety reasons.
(8) - (10) (No change.)
(e) - (f) (No change.)
(g) Recall Procedures.
(1) The pharmacy shall have written procedures for the recall of any compounded non-sterile preparations provided to a patient, to a practitioner for office use, or a pharmacy for administration. Written procedures shall include, but not be limited to the requirements as specified in paragraph (3) of this subsection.
(2) The pharmacy shall immediately initiate a recall of any non-sterile preparation compounded by the pharmacy upon identification of a potential or confirmed harm to a patient.
(3) If the pharmacy identifies a potential or confirmed harm to a patient, the pharmacist-in-charge shall ensure that:
(A) each practitioner, facility, and/or pharmacy to which the preparation was distributed is notified, in writing, of the recall;
(B) each patient to whom the preparation was dispensed is notified, in writing, of the recall;
(C) if the preparation is prepared as a batch, the board is notified of the recall, in writing;
(D) if the preparation is distributed for office use, the Texas Department of State Health Services, Drugs and Medical Devices Group, is notified of the recall, in writing;
(E) the preparation is quarantined; and
(F) the pharmacy keeps a written record of the recall including all actions taken to notify all parties and steps taken to ensure corrective measures.
[(1) The pharmacy shall have written procedure for the recall of any
compounded non-sterile preparations provided to a patient, to a practitioner for
office use, or to a pharmacy for administration. The recall procedures shall
require:]
[(A) notification to each practitioner, facility, and/or pharmacy to which
the preparation was distributed;]
[(B) notification to each patient to whom the preparation was dispensed;]
[(C) quarantine of the product if there is a suspicion of harm to a patient;
and]
[(D) a recall if there is probable or confirmed harm to a patient.]
[(2) If the pharmacy identifies a suspicion of, probable, or confirmed harm
to a patient, the pharmacy shall immediately notify and provide information as
required by the board to the following:]
[(A) the Texas Department of State Health Services, Drugs and Medical Devices
Group, if the preparation is distributed for office use; and]
[(B) the board.]
(4) [(3)] The board may require a pharmacy to
initiate [institute ] a recall if there is potential
for [probable ] or confirmed harm to a patient.
§291.133.Pharmacies Compounding Sterile Preparations.
(a) - (c) (No change.)
(d) Operational Standards.
(1) - (9) (No change.)
(10) Drugs, components, and materials used in sterile compounding.
(A) - (G) (No change.)
(H) A pharmacy may not compound a preparation that contains ingredients appearing on a federal or state agency [Food and Drug
Administration ] list of drug products withdrawn or removed from the
market for safety reasons.
(11) - (13) (No change.)
(e) - (f) (No change.)
22 TAC §291.131, §291.133
The Texas State Board of Pharmacy proposes amendments to §291.131, concerning Pharmacies Compounding Non-Sterile Preparations, and §291.133, concerning Pharmacies Compounding Sterile Preparations. The proposed amendments, if adopted, clarify the requirements for the recall of compounded preparations.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rules are in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rules.
Ms. Dodson has determined that, for each year of the first five-year period the rules will be in effect, the public benefit anticipated as a result of enforcing the rules will be to ensure that the proper recall procedures are being practiced by pharmacies that are compounding sterile and non-sterile preparations. There is no fiscal impact for individuals, small or large businesses, or to other entities which are required to comply with these sections.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8008. Comments must be received by 5:00 p.m., July 31, 2012.
The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.131.Pharmacies Compounding Non-Sterile Preparations.
(a) - (c) (No change.)
(d) Operational Standards.
(1) - (6) (No change.)
(7) Drugs, components, and materials used in non-sterile compounding.
(A) - (H) (No change.)
(I) A pharmacy may not compound a preparation that contains ingredients appearing on a federal or state agency [
(8) - (10) (No change.)
(e) - (f) (No change.)
(g) Recall Procedures.
(1) The pharmacy shall have written procedures for the recall of any compounded non-sterile preparations provided to a patient, to a practitioner for office use, or a pharmacy for administration. Written procedures shall include, but not be limited to the requirements as specified in paragraph (3) of this subsection.
(2) The pharmacy shall immediately initiate a recall of any non-sterile preparation compounded by the pharmacy upon identification of a potential or confirmed harm to a patient.
(3) If the pharmacy identifies a potential or confirmed harm to a patient, the pharmacist-in-charge shall ensure that:
(A) each practitioner, facility, and/or pharmacy to which the preparation was distributed is notified, in writing, of the recall;
(B) each patient to whom the preparation was dispensed is notified, in writing, of the recall;
(C) if the preparation is prepared as a batch, the board is notified of the recall, in writing;
(D) if the preparation is distributed for office use, the Texas Department of State Health Services, Drugs and Medical Devices Group, is notified of the recall, in writing;
(E) the preparation is quarantined; and
(F) the pharmacy keeps a written record of the recall including all actions taken to notify all parties and steps taken to ensure corrective measures.
(4) [
§291.133.Pharmacies Compounding Sterile Preparations.
(a) - (c) (No change.)
(d) Operational Standards.
(1) - (9) (No change.)
(10) Drugs, components, and materials used in sterile compounding.
(A) - (G) (No change.)
(H) A pharmacy may not compound a preparation that contains ingredients appearing on a federal or state agency [
(11) - (13) (No change.)
(e) - (f) (No change.)
Thursday, May 10, 2012
Website with Links to All the State Laws Relating to Compounding
The Compounding Pharmacy Compliance website contains links to all the state laws relating to compounding. Click here to view the links. This website also contains other useful information. For example, this website points out that Texas and South Carolina allow the "office use" of compounded medications, but requires a specific contract between pharmacy and practitioner. The specific requirements that must be found in these contracts can be found in each state's rules.
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