SENATE RULES COMMITTEE | AB 377| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ THIRD READING Bill No: AB 377 Author: Solorio (D) Amended: 8/6/12 in Senate Vote: 21 SENATE BUSINESS, PROF. & ECON. DEV. COMM. : 9-0, 6/13/11 AYES: Price, Emmerson, Corbett, Correa, Hernandez, Negrete McLeod, Vargas, Walters, Wyland SENATE APPROPRIATIONS COMMITTEE : 6-0, 8/13/12 AYES: Kehoe, Walters, Alquist, Lieu, Price, Steinberg NO VOTE RECORDED: Dutton ASSEMBLY FLOOR : 70-0, 5/12/11 (Consent) - See last page for vote SUBJECT : Pharmacy SOURCE : California Hospital Association DIGEST : This bill authorizes a centralized hospital packaging pharmacy to prepare medications, by performing specified functions for administration only to inpatients within its own general acute care hospital, or one or more general acute care hospitals under the same ownership and located within 75 miles of each other. ANALYSIS : Existing law: CONTINUED AB 377 Page 2 1. Provides for the practice of pharmacy and the licensing and regulation of pharmacies and pharmacists by the Board of Pharmacy (Board) within the Department of Consumer Affairs. 2. Defines "hospital pharmacy" as a pharmacy licensed by the Board, located within any licensed hospital, institution or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay. 3. Provides that "hospital pharmacy" also includes a pharmacy that may be located outside of the hospital, in another physical plant that is regulated under a hospital's consolidated license issued by the Department of Corrections and Rehabilitations or Department of Youth Authority. Specifies that the pharmacy in another physical plant shall provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the hospital is located. Specifies that the pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. 4. State that any pharmacy that contracts to compound a drug for parenteral therapy, pursuant to a prescription, for delivery to another pharmacy, must report that contractual arrangement to the Board within 30 days of commencing that compounding. This bill: 1. This bill allows a centralized hospital packaging pharmacy to prepare medications for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership and located within a 75-mile radius of each other. 2. Authorizes a centralized hospital to perform the following specialized functions if each unit dose is AB 377 Page 3 barcoded as specified: A. Preparing unit dose packages for single administration to inpatients from bulk containers. B. Preparing compounded unit dose drugs for parenteral therapy for administration to inpatients. C. Preparing compounded unit dose drugs for administration to inpatients. 3. Defines "common ownership" to mean that the ownership information on file with the Board for the licensed pharmacy is consistent with the ownership information on file for the other licensed pharmacy or pharmacies. 4. Requires, in addition to pharmacy license requirement described in current law, a centralized hospital packaging pharmacy to obtain a specialty license from the Board prior to engaging in the functions authorized by this bill. 5. Requires the Board, before issuing and renewing the specialty license, to inspect the pharmacy and ensure that the pharmacy is in compliance with this bill and regulations it has established. 6. States a license to perform the functions described in this bill shall only be issued to a pharmacy that is licensed by the Board as a hospital pharmacy, and that the license shall be renewed annually and is not transferrable. 7. Sets the fee for issuance or annual renewal of a centralized hospital packaging pharmacy license at $600 and allows it to be increased by the Board to $800. 8. Allows a centralized hospital packaging pharmacy to prepare and store a limited quantity of the unit dose drugs in advance of receipt of a patient-specific prescription in a quantity as is necessary to ensure continuity of care for an identified population of inpatients of the general acute care hospital based on a AB 377 Page 4 documented history of prescriptions for that patient population. 9. Requires any unit dose medication produced by a centralized hospital packaging pharmacy to be barcoded to be readable at the inpatient's bedside. Upon reading the barcode, the following information shall be retrievable: A. The date the medication was prepared. B. The components used in the drug product. C. The lot number or control number. D. The expiration date. E. The National Drug Code Directory lot number. F. The name of the centralized hospital packaging pharmacy. 10.Requires the label for each unit dose medication produced by a centralized hospital packaging pharmacy to contain all of the following: A. The expiration date. B. The established name of the drug. C. The quantity of the active ingredient. D. Special storage or handling requirements. 11.Requires all compounding and packaging functions be performed only in the licensed centralized hospital packaging pharmacy and that pharmacy shall comply with all applicable federal and state statutes and regulations, including, but not limited to, regulations regarding compounding and, when appropriate, sterile injectable compounding. 12.Requires a centralized hospital packaging pharmacy and the pharmacists working in the pharmacy be responsible AB 377 Page 5 for the integrity, potency, quality, and labeled strength of any unit dose drug product prepared by the centralized hospital packaging pharmacy. Background Existing law requires medications for a hospital's patients to be prepared by a licensed pharmacy located on the hospital's premises. Automated processes implemented by a hospital or health system have the potential to provide additional patient protection through a reduction in medication errors. Many medication errors in hospitals have resulted from inadequate and inconsistent labeling and a lack of proper mechanisms to track medication through the distribution process to the patient. Recent reports show that technology like bar-coding facilitates more efficient medication administration and decreases medication errors. According to a study published in the New England Journal of Medicine, "Effect of Bar-Code Technology on the Safety of Medication Administration," use of the bar-code substantially decreased the rate of errors as well as potential adverse drug events. The report also concluded that the bar-code electronic medication administration is an important intervention to improve patient safety. Food and Drug Administration (FDA). Repackaging, distribution, and compounding in advance of a patient prescription are activities currently available only to licensed manufacturers, which are regulated by the United States FDA. Last year, in an email pertaining to a Virginia hospital using a model as proposed in this bill, which is virtually identical to AB 2077 (Soloria, 2010), the FDA stated that "Ýthe proposed health facility pharmacy] system does not need to register as a repacker/relabeler as long as they are servicing their own hospitals within the state of California and repackaged drugs are not commercially distributed and used only within your hospital facilities." While there has not been an official change in FDA policy, it is clear in the FDA's Compliance Policy Guide (460.200) as follows: "FDA will continue to defer to state authorities regarding pharmacy compounding of human drugs." Board Compounding Regulations . New regulations governing AB 377 Page 6 compounding took effect last summer. According to the Board, a Workgroup on Compounding was formed in 2004 comprised of board members, Board staff and industry representatives. The workgroup recognized that current pharmacy regulations addressing compounding only govern the physical circumstances, procedures and record keeping requirements for general compounding and do not address quality, strength or purity. The Board adopted regulations in Article 7 of Division 17 of Title 16 of the California Code of Regulations (commencing with Section 1751) to implement provisions for pharmacies that compound sterile injectable products as required in statute. As there were no similar provisions in regulation for general compounding, the Board approved the addition of language that will establish parameters and provide uniformity for pharmacies that carry out compounding in general (including sterile injectable). Pharmacies that compound sterile injectable products must go above and beyond the requirements for compounding in general. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: Yes According to the Senate Appropriations Committee, minor costs annually to the Board from the Pharmacy Board Contingent Fund, offset by fees. Potentially major costs annually to the Department of Public Health from the Licensing and Certification Program Fund. SUPPORT : (Verified 8/14/12) California Hospital Association (source) AmerisourceBergen Board of Pharmacy California Pharmacists Association California Society of Health-System Pharmacists Los Angeles County Mercy Sharp University of California, San Francisco School of Pharmacy AB 377 Page 7 ASSEMBLY FLOOR : AYES: Achadjian, Allen, Ammiano, Atkins, Beall, Bill Berryhill, Block, Blumenfield, Bonilla, Bradford, Brownley, Buchanan, Butler, Charles Calderon, Campos, Carter, Chesbro, Cook, Davis, Dickinson, Donnelly, Eng, Feuer, Fletcher, Fong, Fuentes, Furutani, Beth Gaines, Galgiani, Gatto, Gordon, Grove, Hagman, Halderman, Hall, Harkey, Hayashi, Hill, Huber, Hueso, Huffman, Jeffries, Jones, Knight, Lara, Logue, Ma, Mansoor, Mendoza, Miller, Monning, Morrell, Nestande, Nielsen, Norby, Olsen, Pan, Perea, V. Manuel Pérez, Silva, Skinner, Smyth, Solorio, Swanson, Valadao, Wagner, Wieckowski, Williams, Yamada, John A. Pérez NO VOTE RECORDED: Alejo, Cedillo, Conway, Garrick, Gorell, Roger Hernández, Bonnie Lowenthal, Mitchell, Portantino, Torres JJA:do 8/14/12 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END ****
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
Monday, August 20, 2012
California Senate Rules Committee: Proposed Law Regarding Compounding At Centralized Hospital Packaging Pharmacy
Franklin Pharmacy: Was It a Manufacturing Plant
Pen N Sword blog has a detailed description of Franklin Pharmacy. The blog begins with:
To read the rest of the Pen N Sword blog click here.
Travel south on Hwy 43 into Russellville and you may easily miss Franklin Pharmacy. It sits at the northern entrance to the small town, located just off the four-lane in a low-lying area not easily observed. A large billboard displays an arrow pointing downward to the two year old complex. Why such a strange location?
Franklin Pharmacy is not just a drug store, but also a manufacturing plant. Among their many compounded products is Optimal Pain Control or OPC, a pain relief cream that is individually tailored to each patient and that has made what locals call a large fortune for owner Tim Aaron. Connected to the drug store is a large metal building where hundreds of workers produce this golden goose, or at least did until last week.
To read the rest of the Pen N Sword blog click here.
Sunday, August 19, 2012
ASPL Pharmacy Law Track and Annual Business Meeting
is scheduled for March 1-4, 2013, in Los Angeles, California. Save the date. More information can be found here.
DEA has announced approved certifying organizations to enable e-prescribing of controlled substances
On August 1, 2012, the DEA announced that it has approved the certification processes for controlled substances e-prescribing systems that have been developed by Drummond Group and iBeta LLC, and that current approvals are posted on the DEA website. Approval of the certification process is the final regulatory step at the federal level to allow CSA e-prescribing, but please notes that some states have yet to modify their statutes to allow for e-prescribing, particularly of Schedule II drugs. [DOJ, DEA, Docket No. DEA-364, Electronic prescriptions for controlled substances: notice of approved certification processes. 77 Fed. Reg. 45688-45689, August 1, 2012;http://1.usa.gov/NSLMro].
2012 Developments in Pharmacy Law Seminar XXIII
The American Society for Pharmacy Law in conjunction with the National Alliance of State
Pharmacy Associations will host the 2012 Developments in Pharmacy Law Seminar XXIII on November 15-18, 2012, at the Ventana Canyon Resort - Tucson, Arizona. The current CE offered includes specific information regarding human and veterinary compounding laws:
8:15 am - 9:15 am 2012 Regulatory Enforcement Update
This past year has seen new and bold actions by law enforcement and
regulators to challenge the practices of pharmacies. The prescription
drug abuse problem continues to cast a pall on the legitimate practice
of pharmacy, and the federal government, through the DEA and FDA,
have stepped up regulatory enforcement actions at pharmacies. It will
be the aim of this presentation to review these legal developments
and to provide guidance regarding measures that can be undertaken
by pharmacies and their counsel to protect the pharmacy and offset
the actions of the regulators.
William E. Fassett, PhD, RPh, Washington State University College of
Pharmacy; Ronald Friedman, JD, Lane Powell (1 credit hour)
9:15am – 10:15 am Developments in Controlled Substances
Regulation and a Foggy Crystal Ball
This presentation will provide additional details about the history of
DEA regulatory interpretation and reaction to judicial decisions, the
rationale for DEA enforcement actions, and some predictions about
the future directions for DEA rule-making and enforcement.
D. Linden Barber, JD; Larry P. Cote, JD, Quarles & Brady LLP (1 credit
hour)
10:15 am – 10.30 am Break
10:30 am – 12:00 pm Social Media Land Mines for Pharmacists
The growth of social media has challenged attorneys to apply
traditional legal principals to new technology. This program will briefly
describe the various forms of social media and explain application
of legal principals related to defamation, privacy, trade secret,
employment, the litigation process, and attorney ethics to the still
evolving world of social media.
Randy Dryer, JD, Parsons, Behle & Latimer (1.5 credit hours)
12:00 pm – 1:00 pm Lunch - ASPL
1:00 pm – 3:00 pm Case Law Update
Again this past twelve months, courts, including the U.S. Supreme
Court, have made far reaching decisions that will impact pharmacies,
pharmacists, and the pharmaceutical industry. This annual
presentation will discuss the Supreme Court’s decisions to uphold
PPACA, as well as court decisions that address the scope of pharmacists’
duty to warn, the reach of the DEA authority, employee and employer
rights, privacy and patient communications, conscientious objection
sanctions, and other topics.
Roger Morris, RPh, JD, Quarles & Brady LLP; William J. Stilling, RPh, JD,
Parsons Behle & Latimer (2 credit hours)
3:15 pm – 4:45 pm HIPAA and HITECH: More Privacy and
Security Regulations and Their Impact on Pharmacy Compliance,
Patient Counseling, and Law Firms
The passage of the Health Information Technology for Economic
and Clinical Health (HITECH) Act in 2009 heralded new privacy and
security requirements and more onerous penalties and enforcement
of HIPAA. HHS has issued several versions of rules to implement
the security breach, business associate, and penalty provisions.
This presentation will explain how these provisions affect how
pharmacies must comply, the impact of HIPAA and HITECH on patient
counseling, and how lawyers must comply with privacy and security
requirements as business associates.
Kevin N. Nicholson, RPh, JD, NACDS; Susan A. Buckna, JD, Shopko
Stores Operating Company (1.5 credit hours)
6:30 pm – 9:30 pm Reception/Dinner - ASPL/NASPA
Saturday, November 17, 2012
7:00 am – 8:00 am Breakfast - ASPL/NASPA
8:00 am– 9:30am Legislative & Regulatory Update
This annual session will provide an overview of recently enacted and
proposed laws and regulations that affect pharmacy.
Brian Gallagher, BS Pharm, JD, American Pharmacists Association
(1.5 credit hours)
9:30 am – 10:30 am Ethical Decision Making for Attorneys
and Pharmacists
As professional both pharmacists and lawyers face times in their day
when ethical decisions need to be made. In this program we will
explore selected parts of the legal Code of Professional Responsibility
and the Pharmacist Code of Ethics as principles that can be applied
to ethical decision making for both professions. We will explore
teaching from Aristotle to General Patton and others to construct
an ethical decision making algorism.
Kenneth R. Baker, RPh, JD, Ken Baker Consulting (1 credit hour)
10:30 am – 10:45 am Break
10:45 am – 12:15 pm Veterinary and Human Compounding
Since the Food and Drug Administration Modernization Act (FDAMA)
of 1997 was passed, confusion has reigned over the legal parameters
for pharmacy compounding. Contradictory court decisions, FDA’s
interpretation and enforcement of laws, and dissonance between
FDAMA and FDA guidelines, have all contributed to the confusion.
Similar factors have confounded compounders of veterinary
products. This presentation will explain the laws, regulations, and
court decisions affecting human and veterinary compounding so
attendees can better understand the law and enforcement in these
areas. Held in cooperation with the Food and Drug Law Institute.
Mark S. Brown, JD, King and Spalding LLP (1.5 credit hours)
1:30 pm– 4:00 pm Pharmacy Law Educators
This years pharmacy law education session will include a presentation
and workshop component. The presentation will discuss active
learning in and outside of the classroom while the workshops will
include groups developing potential exercises and assignments that
can be used for pharmacy law professors.Sunday, November 18, 2012
7:00 am – 8:00 am Breakfast ASPL
8:00 am– 9:00 am Trends in the Regulation of Automation
This session will examine the types of automation available and
application in patient care settings. The speakers will review select
states’ regulation of automation, including an examination of the five
W’s – Who can utilize automation, What medications may be stored,
Why automation is used, Where automation is permitted, and When
automation can be used; as well as potential federal Anti-Kickback
Statute, Stark Law, and DEA issues.
Anne M. O’Brien, JD; Edward D. Rickert, BPharm, RPh, JD, Krieg
DeVault (1 credit hour)
9:00 am – 10:00 am Drug Manufacturer Coupon Co-Pay
Programs: Legal, Policy and Business Considerations
As drug manufacturers face rigorous formulary reviews for their
products, stern generic and brand competition, and loss of
exclusivity, the advancement of coupon co-pay programs have given
them a new and forceful tool in their armamentarium to increase
market share and drive profit. The presentation will review the legal,
policy, and business aspects of Drug Manufacturer Coupon Co-Pay
Programs and assess the value for the relevant stakeholders.
Matthew Seamon, PharmD, JD, Association Professor Nova
Southeastern University College of Pharmacy, Of Counsel Fuerst Ittlmen
(1 credit hour)
10:00 am – 10:15 am Break
10:15 am – 11:15 am Medication Therapy Management:
Nuts, Bolts, and Legal Considerations
Medicare Part D requires prescription drug programs to provide
Medication Therapy Management (MTM) for Medicare beneficiaries.
This presentation will discuss the requirements for MTM, how
pharmacists carry out MTM programs, recent changes in the Part
D regulations governing MTM, the legal requirements and risks of
MTM as this type of monitoring and intervention spreads to the
private sector.
Doug Burgoyne, PharmD, RPh, VRx Pharmacy Services (1 credit
hour)
11:15 am – 12:15 pm Challenges to Compliance in Current
Regulatory Framework
As the regulatory environment becomes more complex, pharmacies
are more frequently being investigated by administrative agencies.
This program will discuss the ten most common compliance
issues that are being faced by pharmacies before state boards of
pharmacy, state controlled substance authorities, the Food and
Drug Administration, and the Drug Enforcement Administration.
It will also provide a framework for conducting self-audits of
pharmacy operations practices and strategies for responding to
agency investigations.
Laura Carpenter, RPh, JD, LLM, Carpenter Law Firm PC; Michael
Simko, JD, Walgreens (1 credit hour)
Register Today at www.aspl.org
Pharmacy Associations will host the 2012 Developments in Pharmacy Law Seminar XXIII on November 15-18, 2012, at the Ventana Canyon Resort - Tucson, Arizona. The current CE offered includes specific information regarding human and veterinary compounding laws:
8:15 am - 9:15 am 2012 Regulatory Enforcement Update
This past year has seen new and bold actions by law enforcement and
regulators to challenge the practices of pharmacies. The prescription
drug abuse problem continues to cast a pall on the legitimate practice
of pharmacy, and the federal government, through the DEA and FDA,
have stepped up regulatory enforcement actions at pharmacies. It will
be the aim of this presentation to review these legal developments
and to provide guidance regarding measures that can be undertaken
by pharmacies and their counsel to protect the pharmacy and offset
the actions of the regulators.
William E. Fassett, PhD, RPh, Washington State University College of
Pharmacy; Ronald Friedman, JD, Lane Powell (1 credit hour)
9:15am – 10:15 am Developments in Controlled Substances
Regulation and a Foggy Crystal Ball
This presentation will provide additional details about the history of
DEA regulatory interpretation and reaction to judicial decisions, the
rationale for DEA enforcement actions, and some predictions about
the future directions for DEA rule-making and enforcement.
D. Linden Barber, JD; Larry P. Cote, JD, Quarles & Brady LLP (1 credit
hour)
10:15 am – 10.30 am Break
10:30 am – 12:00 pm Social Media Land Mines for Pharmacists
The growth of social media has challenged attorneys to apply
traditional legal principals to new technology. This program will briefly
describe the various forms of social media and explain application
of legal principals related to defamation, privacy, trade secret,
employment, the litigation process, and attorney ethics to the still
evolving world of social media.
Randy Dryer, JD, Parsons, Behle & Latimer (1.5 credit hours)
12:00 pm – 1:00 pm Lunch - ASPL
1:00 pm – 3:00 pm Case Law Update
Again this past twelve months, courts, including the U.S. Supreme
Court, have made far reaching decisions that will impact pharmacies,
pharmacists, and the pharmaceutical industry. This annual
presentation will discuss the Supreme Court’s decisions to uphold
PPACA, as well as court decisions that address the scope of pharmacists’
duty to warn, the reach of the DEA authority, employee and employer
rights, privacy and patient communications, conscientious objection
sanctions, and other topics.
Roger Morris, RPh, JD, Quarles & Brady LLP; William J. Stilling, RPh, JD,
Parsons Behle & Latimer (2 credit hours)
3:15 pm – 4:45 pm HIPAA and HITECH: More Privacy and
Security Regulations and Their Impact on Pharmacy Compliance,
Patient Counseling, and Law Firms
The passage of the Health Information Technology for Economic
and Clinical Health (HITECH) Act in 2009 heralded new privacy and
security requirements and more onerous penalties and enforcement
of HIPAA. HHS has issued several versions of rules to implement
the security breach, business associate, and penalty provisions.
This presentation will explain how these provisions affect how
pharmacies must comply, the impact of HIPAA and HITECH on patient
counseling, and how lawyers must comply with privacy and security
requirements as business associates.
Kevin N. Nicholson, RPh, JD, NACDS; Susan A. Buckna, JD, Shopko
Stores Operating Company (1.5 credit hours)
6:30 pm – 9:30 pm Reception/Dinner - ASPL/NASPA
Saturday, November 17, 2012
7:00 am – 8:00 am Breakfast - ASPL/NASPA
8:00 am– 9:30am Legislative & Regulatory Update
This annual session will provide an overview of recently enacted and
proposed laws and regulations that affect pharmacy.
Brian Gallagher, BS Pharm, JD, American Pharmacists Association
(1.5 credit hours)
9:30 am – 10:30 am Ethical Decision Making for Attorneys
and Pharmacists
As professional both pharmacists and lawyers face times in their day
when ethical decisions need to be made. In this program we will
explore selected parts of the legal Code of Professional Responsibility
and the Pharmacist Code of Ethics as principles that can be applied
to ethical decision making for both professions. We will explore
teaching from Aristotle to General Patton and others to construct
an ethical decision making algorism.
Kenneth R. Baker, RPh, JD, Ken Baker Consulting (1 credit hour)
10:30 am – 10:45 am Break
10:45 am – 12:15 pm Veterinary and Human Compounding
Since the Food and Drug Administration Modernization Act (FDAMA)
of 1997 was passed, confusion has reigned over the legal parameters
for pharmacy compounding. Contradictory court decisions, FDA’s
interpretation and enforcement of laws, and dissonance between
FDAMA and FDA guidelines, have all contributed to the confusion.
Similar factors have confounded compounders of veterinary
products. This presentation will explain the laws, regulations, and
court decisions affecting human and veterinary compounding so
attendees can better understand the law and enforcement in these
areas. Held in cooperation with the Food and Drug Law Institute.
Mark S. Brown, JD, King and Spalding LLP (1.5 credit hours)
1:30 pm– 4:00 pm Pharmacy Law Educators
This years pharmacy law education session will include a presentation
and workshop component. The presentation will discuss active
learning in and outside of the classroom while the workshops will
include groups developing potential exercises and assignments that
can be used for pharmacy law professors.Sunday, November 18, 2012
7:00 am – 8:00 am Breakfast ASPL
8:00 am– 9:00 am Trends in the Regulation of Automation
This session will examine the types of automation available and
application in patient care settings. The speakers will review select
states’ regulation of automation, including an examination of the five
W’s – Who can utilize automation, What medications may be stored,
Why automation is used, Where automation is permitted, and When
automation can be used; as well as potential federal Anti-Kickback
Statute, Stark Law, and DEA issues.
Anne M. O’Brien, JD; Edward D. Rickert, BPharm, RPh, JD, Krieg
DeVault (1 credit hour)
9:00 am – 10:00 am Drug Manufacturer Coupon Co-Pay
Programs: Legal, Policy and Business Considerations
As drug manufacturers face rigorous formulary reviews for their
products, stern generic and brand competition, and loss of
exclusivity, the advancement of coupon co-pay programs have given
them a new and forceful tool in their armamentarium to increase
market share and drive profit. The presentation will review the legal,
policy, and business aspects of Drug Manufacturer Coupon Co-Pay
Programs and assess the value for the relevant stakeholders.
Matthew Seamon, PharmD, JD, Association Professor Nova
Southeastern University College of Pharmacy, Of Counsel Fuerst Ittlmen
(1 credit hour)
10:00 am – 10:15 am Break
10:15 am – 11:15 am Medication Therapy Management:
Nuts, Bolts, and Legal Considerations
Medicare Part D requires prescription drug programs to provide
Medication Therapy Management (MTM) for Medicare beneficiaries.
This presentation will discuss the requirements for MTM, how
pharmacists carry out MTM programs, recent changes in the Part
D regulations governing MTM, the legal requirements and risks of
MTM as this type of monitoring and intervention spreads to the
private sector.
Doug Burgoyne, PharmD, RPh, VRx Pharmacy Services (1 credit
hour)
11:15 am – 12:15 pm Challenges to Compliance in Current
Regulatory Framework
As the regulatory environment becomes more complex, pharmacies
are more frequently being investigated by administrative agencies.
This program will discuss the ten most common compliance
issues that are being faced by pharmacies before state boards of
pharmacy, state controlled substance authorities, the Food and
Drug Administration, and the Drug Enforcement Administration.
It will also provide a framework for conducting self-audits of
pharmacy operations practices and strategies for responding to
agency investigations.
Laura Carpenter, RPh, JD, LLM, Carpenter Law Firm PC; Michael
Simko, JD, Walgreens (1 credit hour)
Register Today at www.aspl.org
Saturday, August 18, 2012
The minutes from the May 2012 Texas State Board of Pharmacy have been posted. The minutes relating to compounded preparations are as follows:
Rules Concerning Recall Procedures for Compounded Preparations
(§§291.131 and 291.133) (Tab 13)
Ms. Benz directed the Board’s attention to suggested amendments to
§§291.131 and 291.133 and explained the amendments clarify the
requirements for the recall of compounded preparations. Ms. Benz
recommended that the proposed rule be changed so that written
notifications to the Board concerning recalls be limited to batch
preparations only.
Following discussion, the motion was made by Mr. Wetherbee to
approve for proposal amendments to §§291.131 and 291.133 with
changes recommended by Board staff. The motion was seconded by
Ms. Mendoza and passed unanimously.Entire minutes can be viewed here.
Dr. Loyd Allen's Editorial on Reimbursement Discrimination
In the current issue of Compounding Today, Dr. Loyd Allen makes some excellent points about reimbursement discrimination when it comes to FDA approved drugs versus compounded drugs. For example, Dr. Allen states:
To read the rest of Dr. Allen's comments click here.
They will pay for compounded medications when the patient is in the hospital (intravenous admixtures, TPN solutions, oncology cocktails, etc.) but will not pay for medications from an independent pharmacy for the same patient. To make things even more conflicting, in some cases it is the same independent pharmacies that are preparing the medications for the hospitals due to drug shortages, etc.
FDA Rules Apply to Veterinarians
Uh…Yeah…It DOES apply to you!
16ThursdayAug 2012
By David G. Miller, RPh, IACP Executive Vice President & CEO
Weekend before last, Sarah (IACP Vice President of Government Affairs) and I had the opportunity to give a presentation at the annual convention of the American Veterinary Medical Association (AVMA). Our original topic was to give an overview of the US v. Franck’s Lab, Inc. case.
To read the rest of David Miller's comments click here
Report Says China and India are emerging as global superpowers in the API industry
China and India are emerging as global superpowers in the API industry offering promising features, says RNCOS.
According to a new research report by RNCOS, entitled “Global Biotech API Market Analysis”, China and India are emerging as global superpowers in the API industry. The availability of cheap resources, such as infrastructure, labor, raw materials, etc accompanied by the advancing pharma expertise is one of the key factors backing this growth. Both the economies present a very bright opportunity for CRAMS as several pharma manufacturers outsource their APIs and intermediaries to these two low-end economies. While generics are a mainstay for the API industry in both the countries, India is posing a threat to India as its generic API industry has outshone that of China.
The rapidly evolving pharma market and increasing demands for drugs worldwide is primarily driving growth in the global API market. While the generic and the branded APIs represent equal share in the API merchant market, the growth of generics is expected to be incessant. The initiatives by the government to cut down on burgeoning costs have resulted in the active promotion of the generics market. Biotechnological APIs are also expected to evolve in the market. The rising patent expiries among the biopharmaceutical products in Europe and the US will increase the demand for bulk drugs. Further a latest report by RNCOS, also foresees the worldwide API market size to be likely to register a healthy CAGR of around 8% during 2012-2015.
The report spread in over 55 pages provides a proper understanding of the API market globally along with an idea about its current state. The key industry drivers have been covered in details along with the current and future market projections for the time period of 2012-2015. The major segments and sub-segments of the API industry have been covered along with the description of the API industry in the most promising geographies of India, China, Italy and Taiwan. The report also analyzes the opportunity assessment for companies in the global APIs market in terms of therapeutic segments and countries’ comparative index. An analysis of the emerging areas, competitive landscape, and regulatory stringency further provides a holistic understanding of the global API market.
For FREE SAMPLE of this report visit: http://www.rncos.com/Report/IM424.htm
The rapidly evolving pharma market and increasing demands for drugs worldwide is primarily driving growth in the global API market. While the generic and the branded APIs represent equal share in the API merchant market, the growth of generics is expected to be incessant. The initiatives by the government to cut down on burgeoning costs have resulted in the active promotion of the generics market. Biotechnological APIs are also expected to evolve in the market. The rising patent expiries among the biopharmaceutical products in Europe and the US will increase the demand for bulk drugs. Further a latest report by RNCOS, also foresees the worldwide API market size to be likely to register a healthy CAGR of around 8% during 2012-2015.
The report spread in over 55 pages provides a proper understanding of the API market globally along with an idea about its current state. The key industry drivers have been covered in details along with the current and future market projections for the time period of 2012-2015. The major segments and sub-segments of the API industry have been covered along with the description of the API industry in the most promising geographies of India, China, Italy and Taiwan. The report also analyzes the opportunity assessment for companies in the global APIs market in terms of therapeutic segments and countries’ comparative index. An analysis of the emerging areas, competitive landscape, and regulatory stringency further provides a holistic understanding of the global API market.
For FREE SAMPLE of this report visit: http://www.rncos.com/Report/IM424.htm
Source is found here.
IACP Calendar of Seminars, Conferences and Courses
The International Academy of Compounding Pharmacists has a wonderful calendar with dates for all the upcoming seminars, conferences, and courses related to compounding. The calendar can be viewed here.
Correct coding of compound drugs for BCBST in Tennessee
Any legend drug altered from its manufactured form for use by a specific
patient is considered a compound. Since compounded medications do not have an
NDC number, specific HCPCS Level II codes may not be used. Eligible compound
drugs must be billed with the most appropriate HCPCS Level II unclassified/not otherwise classified code. An example of a compounded medication is bevacizumab (Avastin®) for intravitreal
injection. Bevacizumab is supplied from the manufacturer in 400 mg and 100 mg
vials with a concentration of 25 mg / mL. It is typically repackaged into single dose
syringes with a concentration of 1.25 mg /0.05 mL for intravitreal injection and must
be prepared under sterile conditions by a compounding pharmacy prior to ocular use.
Effective Aug. 1, 2012, for each date of service compound drugs are administered,
instilled, inserted, or implanted, a reasonable compounding fee will be
reimbursed for commercial and BlueAdvantage claims if the pharmacy
compounding fee is submitted on a separate line item billed with the appropriate HCPCS
code for Pharmacy compounding and dispensing services. Billing guidelines for compound drugs can be reviewed in the billing and reimbursement section of the BlueCross
BlueShield of Tennessee Provider Administration Manual found online at
www.bcbst.com.
Article is found here.
Should Sales Reps for Compounded Drugs be Paid a Salary or a Commission? Should This Be a Factor that the FDA and State Boards of Pharmacy Consider?
In running across a recent advertisement for a job for veterinary compounding pharmacy in Texas as a pharmaceutical sales representative, I observed that the job was based on a commission like other pharmaceutical sales jobs. A friend in the business and I then had a discussion about whether these jobs, pharmaceutical sales representative jobs for compounding pharmacies, should be commission or salary. The friend is probably one of the few in the industry who is paid a salary for his work as a pharmaceutical sales representative for a compounding pharmacy. He strongly believes that this is the correct position and that if one is paid a commission for this type of work it indicates that the pharmacy is manufacturing because compounded drugs for both humans and animals are suppose to be patient-specific and not produced in mass-quantities. If one is being paid a commission does this indicate the company is manufacturing instead of producing patient-specific compounds? Should this be a factor that the FDA and the state boards of pharmacy examine? How many sales representatives for compounding pharmacies are paid a salary instead of a commission? I am interested in what readers have to say about this issue. Readers please comment.
BREAKING NEWS: Indicted pharmacist found dead
BREAKING NEWS: Indicted pharmacist found dead: Unsealed charges paint picture of drug conspiracy, multimillion-dollar insurance fraud
Franklin Pharmacy Suspending Its Compounding Operation in Russellville: It Employed Close ot 200 People
Closing of compounding center to affect many
Published 6:00am Saturday, August 18, 2012
When the state unemployment numbers were released Friday, Franklin County’s jobless claims for July held steady at 9.7 percent, just slightly above the 9.6 percent reported in June.
The county’s July rate represents 1,315 individuals, but that number is certain to rise on the heels of Thursday’s announcement that Franklin Pharmacy would be suspending its compounding operation in Russellville.
Though company officials have not commented publicly, several employees of the pharmacy confirmed Friday that they were sent home Thursday and told that the compounding operation would be closed. Close to 200 people were employed there and it is uncertain how many will remain.
The announcement was made one week after federal and state agencies raided Franklin Pharmacy and two others, Russellville Pharmacy and Sheffield Pharmacy.
To read remainder of article click here
The county’s July rate represents 1,315 individuals, but that number is certain to rise on the heels of Thursday’s announcement that Franklin Pharmacy would be suspending its compounding operation in Russellville.
Though company officials have not commented publicly, several employees of the pharmacy confirmed Friday that they were sent home Thursday and told that the compounding operation would be closed. Close to 200 people were employed there and it is uncertain how many will remain.
The announcement was made one week after federal and state agencies raided Franklin Pharmacy and two others, Russellville Pharmacy and Sheffield Pharmacy.
To read remainder of article click here
Friday, August 17, 2012
FDA Question and Answers Regarding Compounded Memopausal Hormone Therapy
Compounded Menopausal Hormone Therapy Questions and Answers
Pharmacy CompoundingMenopausal Hormone Therapy and “Bio-identical” HormonesFDA’s Enforcement Action Against Compounded “BHRT” drugsFDA’s Response to Wyeth’s Citizen Petition
Pharmacy Compounding
1. What is pharmacy compounding?
FDA regards traditional pharmacy compounding as the combining or altering of ingredients by a pharmacist, in response to a licensed practitioner’s prescription, to produce a drug tailored to an individual patient’s special medical needs. In its simplest form, traditional compounding may involve reformulating a drug, for example, by removing a dye or preservative in response to a patient allergy. In the case of menopausal hormone therapy, an FDA approved progesterone product contains peanut oil. Progesterone compounded without peanut oil in response to a prescription for a specific patient who is allergic to this ingredient might allow the patient to safely use the drug.
2. Is combining two or more drugs considered compounding?
FDA would consider the combining of two or more FDA-approved drugs into a single medication, in a manner not described in a drug’s FDA-approved labeling, to be compounding if it is done by a pharmacist in response to a licensed practitioner’s prescription and produces a medication tailored to an individual patient’s special medical needs.
3. Is pharmacy compounding beneficial for patients?
It can be. Traditional pharmacy compounding enhances patient treatment with individually-tailored drugs when a physician deems that an FDA-approved drug may not be available or appropriate for that patient's care. Thus, traditional compounding is an important component of patient care.
4. What are the risks associated with compounded drugs?
Compounded drugs can pose both direct and indirect health risks. Direct health risks include unsafe compounded products. Compounded drugs may be unsafe and compounded drugs made using poor quality compounding practices may be sub- or super‑potent, contaminated, or otherwise adulterated. Indirect health risks include the possibility that patients will use ineffective compounded drugs instead of FDA-approved drugs that have been shown to be safe and effective.Some pharmacists are well-trained and well-equipped to compound certain medications safely. But not all pharmacists have the same level of skills and equipment, and some drugs may be inappropriate for compounding. In some cases, compounders may lack sufficient controls (e.g., equipment, training, testing, or facilities) to ensure product quality or to compound complex drugs like sterile or extended-release drugs. The quality of the drugs that these pharmacists compound is unknown and these drugs pose potential risks to the patients who take them.When pharmacy compounders both operate like drug manufacturers and engage in high‑volume distribution, the risk of patient harm increases. Over the past several years, FDA has become aware of serious adverse events, including deaths, associated with compounded drugs. For example:
- In December 2006, FDA issued warning letters to five firms about their standardized compounded, high‑strength topical anesthetic creams. Two deaths were connected to the topical anesthetics compounded by two of the pharmacies.
- In August 2006, FDA warned three firms to stop manufacturing and distributing thousands of doses of unapproved inhalation drugs under the guise of compounding. Warning letters to these firms identify a range of serious concerns including inadequate quality control, concerns about potency, and compounding copies of FDA-approved drugs.
- In March 2006, FDA issued a warning letter to a Maryland firm regarding its compounding of cardioplegia solutions – used in open-heart surgery – that were contaminated. The contaminated solutions caused severe systemic infections in five patients at a hospital in Virginia. Three of the five patients died from their infections.
5. Does FDA want to prevent pharmacy compounding?
No. FDA believes that pharmacists engaging in traditional compounding provide a valuable medical service that is important to patient health. FDA has no interest in ending traditional pharmacy compounding and focuses instead on the subset of inappropriate compounding described in FDA’s Pharmacy Compounding CPG. The CPG is available on FDA’s pharmacy compounding Web page.
U.S. Drug Shortage:Pfizer and India
Pfizer Seen Circling Agila With U.S. Drug Shortages
A shortage of injectable drugs in the U.S. means India's Strides Arcolab Ltd.
could sell a division that makes generic cancer treatments and antibiotics for
more than the entire company's market value.
Raid closes alleged drug shop in Kansas
Posted on 17 August 2012. Tags: Chris Hoover, Drugs
A local business was raided last Monday by Lyon County authorities and the Kansas Bureau of Investigation for alleged involvement in a synthetic drug ring. The KBI coordinated with local authorities to conduct a seven-month long investigation into the suspected sale of synthetic cannabinoids XR-11 and Ur-144, also known as potpourri, at Blitzed Detox Shop, located at 5 E. 7th Ave, and other business in Kansas.
To read the remainder of this blog entry click here.
To read the remainder of this blog entry click here.
Thursday, August 16, 2012
What Information is Available
The NABP August 2012 Newsletter deals with Information on What's Available, written by Dale J. Atkinson, J.D. The article addresses open records act and pharmacy boards. To view the article, click here.
K-V v. Keck: State of South Carolina's Motion in Opposition
K-V v. Keck: State of South Carolina's Motion to Dismiss
To view the State of South Carolina's Motion to Dismiss, click here.
A Pharmacist's Duty To Warn
To review a summary of state law prepared by the National Association of Chain Drug Stores, click here.
Wednesday, August 15, 2012
State of South Carolina Files Motion to Dismiss for Failure to State a Claim in K-V v. Keck
08/13/2012 | 22 | MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM by Anthony Keck. Response to Motion due by 8/30/2012. (Attachments: # 1 Memo in Support of Motion to Dismiss)No proposed order.(Strom, Joseph) (Entered: 08/13/2012) |
08/13/2012 | 23 | RESPONSE in Opposition re 6 MOTION for Preliminary Injunction Response filed by Anthony Keck.Reply to Response to Motion due by 8/23/2012 (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4, # 5 Exhibit 5, # 6 Exhibit 6)(Strom, Joseph) (Entered: 08/13/2012) |
Oral Argument in Franck's Now Set for 11/2/2012 in Atlanta
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DOMPERIDONE COMPOUNDING PERMISSIBLE ONLY AS PART OF AN INVESTIGATIONAL NEW DRUG APPLICATION (IND).
Statement from the North Carolina Board of Pharmacy found here:
TUESDAY, AUGUST 14, 2012
DOMPERIDONE COMPOUNDING PERMISSIBLE ONLY AS PART OF AN INVESTIGATIONAL NEW DRUG APPLICATION (IND). Board staff have received calls and questions about the compounding of domperidone. Domperidone is not a drug approved for human use in the United States. Accordingly, any domperidone product dispensed in the United States outside of an IND is unapproved, adulterated and misbranded under both federal and North Carolina law. Notwithstanding misleading Internet information to the contrary, it is not legal in the United States to acquire, compound, dispense, or administer domperidone outside of an IND. The FDA has long provided clear guidance on this point, which may be found here: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm073070.htm
As FDA’s information further states, "FDA has determined that domperidone should not be compounded or used to enhance breast milk production in lactating women." Domperidone may be useful for "some patients with severe gastrointestinal disorders . . . that are refractory to standard therapy." A physician who would like to prescribe domperidone for this indication may contact FDA to open an Investigational New Drug Application (IND). An FDA-authorized IND would "allow the importation, interstate shipment, and administration of the drug even though it is not approved for sale in the U.S."
Pharmacists are expected to conform their conduct to these legal requirements.
Tuesday, August 14, 2012
Seminar on How to Survive a DEA Inspection for Compounding Controlled Substances
How to Survive a DEA Inspection Series: Compounding Controlled Substances
Published by International Academy of Compounding Pharmacists and Texas Pharmacy Association
Summary
Part Four of a Four-Part Series.
The responsibilities to enforced federal laws and regulations on the compounding of controlled substances by a pharmacy are placed on the Drug Enforcement Administration (DEA) through their Office of Diversion Control (Diversion).
Since the focus of any DEA compliance inspection is record-keeping, a compounding pharmacy will need to be prepared for that unannounced inspection that will focus on the purpose for compounding medications containing controlled substances and records required by DEA to be maintained by the pharmacy.
Attendees will familiarize themselves with the types of actions taken by DEA Diversion personnel at a compounding pharmacy. The focus of any compounding pharmacy is whether the pharmacy is compounding for a specific patient or group of patients needing a medication or the manufacturing of a controlled substance medication.
Learning Objectives:
At the conclusion of this program, the pharmacist and technician attendee will be able to:
The responsibilities to enforced federal laws and regulations on the compounding of controlled substances by a pharmacy are placed on the Drug Enforcement Administration (DEA) through their Office of Diversion Control (Diversion).
Since the focus of any DEA compliance inspection is record-keeping, a compounding pharmacy will need to be prepared for that unannounced inspection that will focus on the purpose for compounding medications containing controlled substances and records required by DEA to be maintained by the pharmacy.
Attendees will familiarize themselves with the types of actions taken by DEA Diversion personnel at a compounding pharmacy. The focus of any compounding pharmacy is whether the pharmacy is compounding for a specific patient or group of patients needing a medication or the manufacturing of a controlled substance medication.
Learning Objectives:
At the conclusion of this program, the pharmacist and technician attendee will be able to:
- Identify the authority of Drug Enforcement Administration (DEA) Office of Diversion Control (Diversion) personnel to conduct an unannounced inspection at a compounding pharmacy and records that will be inspected or copied by their personnel.
- Discuss administrative or civil actions taken by DEA for failure of a pharmacy to maintain compounding records for Schedules II through V prescriptions filled or compounded by the pharmacy.
- Identify DEA record-keeping violations pertaining to: Inventory of Controlled Substances, Batch Records, Power of Attorney forms and other records required to be maintained by the compounding pharmacy.
- Discuss the failure of specific DEA Diversion offices to understand the difference between anticipatory compounding versus manufacturing and how a compounding pharmacy can handle such issue when DEA enters the pharmacy.
FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed: GAO-10-961:
GAO-10-961: GAO Highlights: Highlights of GAO-10-961, a report to the Committee on Oversight and Government Reform, House of Representatives. Why GAO Did This Study: Globalization has placed increasing demands on the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), in ensuring the safety and effectiveness of drugs marketed in the United States. Drugs manufactured in more than 100 countries were offered for entry into the United States in fiscal year 2009. FDA inspects drug manufacturing establishments in order to ensure that the safety and quality of drugs are not jeopardized by poor manufacturing practices. In 1998 GAO identified weaknesses in FDA’s foreign drug inspection program. In 2008 GAO found, among other things, that from fiscal years 2002 through 2007, FDA inspected relatively few foreign establishments each year. GAO also determined that, because of inaccurate information in its databases, FDA did not know how many foreign drug establishments were subject to inspection. In 2008 GAO recommended that FDA increase inspections of foreign drug establishments and improve information it receives to manage the foreign drug inspection program. This report examines FDA’s progress since 2008 in (1) conducting more foreign drug inspections, and (2) improving its information on foreign drug establishments. GAO analyzed information from FDA databases, reviewed documents related to FDA’s efforts to both improve these databases and supplement its existing information on foreign drug establishments, examined staffing and funding information, and interviewed FDA officials. What GAO Found: FDA increased the number of foreign drug inspections it conducted from fiscal year 2007 to 2009, but still conducts relatively fewer foreign drug inspections each year than it conducts domestically. In fiscal year 2009, FDA conducted 424 foreign inspections, compared to 333 and 324 inspections conducted in fiscal years 2007 and 2008, respectively. Using a list FDA developed to prioritize foreign establishments for inspection, GAO estimated that FDA inspected 11 percent of foreign establishments on this list in fiscal year 2009. At this rate, GAO estimated it would take FDA about 9 years to inspect all establishments on this list once. In contrast, in that same year, FDA conducted 1,015 domestic inspections, inspecting approximately 40 percent of domestic establishments. GAO estimated that at this rate FDA inspects domestic establishments approximately once every 2.5 years. Further, FDA’s approach in selecting establishments for inspection is inconsistent with GAO’s 2008 recommendation that FDA inspect, at a comparable frequency, those establishments that are identified as having the greatest public health risk potential if they experience a manufacturing defect, regardless of whether they are a foreign or domestic establishment. Instead, its foreign inspections continue to be driven by the establishments listed on an application for a new drug, instead of those already producing drugs for the U.S. market. FDA is taking steps to improve the information it receives from the drug establishment registration and import databases the agency uses to manage its foreign drug inspection program. For example, FDA is working to obtain more accurate information for its database that contains information about foreign establishments registered to market their drugs in the United States. In addition, FDA has an initiative underway to eliminate duplicate information from its database containing information about foreign establishments whose drugs are offered for import into the United States. However, these efforts are in the early stages. In addition, FDA is exploring other options for obtaining better information about foreign drug establishments, such as by collaborating with foreign regulatory authorities to exchange information about planned inspections and the results of completed inspections. In 1998, and again in 2008, GAO reported that FDA needed to conduct more inspections of foreign establishments and that it was vital that the agency strengthen the data it uses to manage its foreign drug inspection program. FDA has begun to respond to GAO’s recommendations; however, it has not yet fully addressed these weaknesses at a time when the volume of imported drugs and the number of foreign establishments producing these drugs have been increasing. Given the long-standing nature of these challenges and the nation’s reliance on drugs manufactured overseas, it is urgent that FDA implement GAO’s prior recommendations to better protect public health. HHS reviewed a draft of this report and agreed that more progress is needed in order to meet the challenge of safeguarding the nation’s drug supply in today’s global marketplace. To read the remainder of the report, click here.
FDA REGULATION OF FOREIGN-MANUFACTURED DRUGS and US Customs Role
Although the testimony below was given before Congress in 2007, it has been updated in 2011 and is very helpful in understanding the FDA's foreign drug inspection program.
The statement is found here.
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