Saturday, January 3, 2015
Friday, January 2, 2015
Third Question of the Day January 2, 2015 Does Congress Need To Hold Additional Hearings like this one now that more and more compounding pharmacies and pharmacists are involved in these promotions and marketing: Swindlers, Hucksters and Snake Oil Salesmen: The Hype and Hope of Marketing Anti-Aging Products to Seniors United States Senate Special Committee on Aging September 10, 2001
complete testimony found here
Canadian Animal Health Institute Facts and Information on using Hormones in the Beef Industry
- CAHI Factsheet “Hormones: A Safe, Effective Production Tool for the Beef Industry”
- Beef Information Centre Factsheet “Understanding Hormone Use In Beef”
Department of Justice Animal Drug Prosecutions -- Generally
7 Healthcare Storylines for 2015 Seven key moments of 2014 foreshadow what will be driving the pharmacy benefit conversation in 2015 (including wastful spending on compounded medications). - See more at: http://lab.express-scripts.com/insights/industry-updates/7-healthcare-storylines-for-2015#sthash.83ajcJSX.dpuf
Second Question of the Day January 2, 2015 Is this something Texas should be proud of? Why or why not?
AUSTIN, Texas, Sept. 9, 2014 /PRNewswire-USNewswire/ -- The Texas Medical Board licensed a record 3,994 new physicians for the fiscal year that ended last month. The board licensed 400 more doctors t...
FDA Warns Compounder for Extensive Quality Violations
Drug Industry Daily
The FDA has warned a Mississippi compounder for not disinfecting its clean room equipment and for other serious manufacturing violations, capping a busy year for the agency’s compounding pharmacy enforcement.
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Feds step up review of complaints from patients who say they were harmed 2015 plan targets oversight gaps SYDNEY FREEDBERG, SCRIPPS NEWS 8:03 AM, JAN 2, 2015 5 HOURS AGO
WASHINGTON, D.C. - Every year, the federal government reviews 100,000 complaints from patients who say they were harmed while receiving medical care. They got surgery they didn't need, drugs that made them sicker, care that took too long to deliver.
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Look at this Question on InvestorHub
Two questions - First, will compounding coverage change drastically as of today? I've heard a lot of private payors indicated their new formularies won't cover compounding. Any thoughts on long-term future of pricate payor coverage? and Second, are all of the sales generated by "employees" or independent contractors? If employees, any idea how many? And if contractors, has there been any discussion about the practical legal risk since it's not a safe harbored transaction?? I know 1099 is common in medical sales but also heard I could be considered a state or fed kickback... Any thoughts? I have not yet invested in SCRC. I'd like to know these two things before deciding to do so. Hopefully someone on this board knows more.
quoted from here
FDA Manual of Policies and Procedures (MAPP) 4100.1 CDER Co-Sponsorship Agreements for Events
- Manual of Policies and Procedures (MAPP) 4100.1 CDER Co-Sponsorship Agreements for Events (PDF - 565KB)
Kudos to the Louisiana Board of Pharmacy--Look at this List of Disciplinary Action-including Oklahoma Compounding LLC for dispensing over 180 prescriptions without the required permit and Randal Riverside Corporation dba Matlock Pharmacy for dispensing over 900 prescriptions without required permit--assessed $50,000 fine
Disciplinary Actions (15-01-481)
During its November 2014 meeting, the Board took final action
in the following matters.
Medical Arts Pharmacy Services, Inc, dba Medical Arts
Pharmacy (PHY Applicant): For its forgery of the name and
signature of the pharmacist-in-charge (PIC) on its application
for a pharmacy permit, the Board denied the application and
refused to issue the permit.
Louisiana CVS Pharmacy, LLC, dba CVS Pharmacy No. 5306
(PHY.005788 and CDS.039634): For its failure to appoint a
replacement PIC for 15 months, for the continued operation
of the pharmacy without a PIC, and for its fraudulent renewal
application, the Board suspended the pharmacy permit and
state CS license for two years and stayed the execution of the
suspension, then placed both credentials on probation for two
years, effective November 13, 2014, and further, assessed a fine
of $100,000 plus administrative and investigative costs.
Louisiana CVS Pharmacy, LLC, dba CVS Pharmacy No. 5612
(PHY.005769): For its failure to appoint a replacement PIC for
five months, and for the continued operation of the pharmacy
without a PIC, the Board assessed a fine of $25,000 plus administrative
and investigative costs.
Norman August Higginbotham (PST.015486): For his failure
to properly perform the required tasks as departing PIC of CVS
Pharmacy No. 5612, the Board issued a letter of reprimand, and
further, assessed a fine of $2,500 plus administrative costs.
Louisiana CVS Pharmacy, LLC, dba CVS Pharmacy No. 1939
(PHY.006316): For its failure to appoint a replacement PIC for
one month, and for the continued operation of the pharmacy
without a PIC, the Board assessed a fine of $15,000 plus administrative
and investigative costs.
Louisiana CVS Pharmacy, LLC, dba CVS Pharmacy No. 8999
(PHY.006285): For its failure to appoint a replacement PIC for
one month, and for the continued operation of the pharmacy
without a PIC, the Board assessed a fine of $15,000 plus administrative
and investigative costs.
Louisiana CVS Pharmacy, LLC, dba CVS Pharmacy No. 1017
(PHY.006018): For its failure to appoint a replacement PIC for
one month, and for the continued operation of the pharmacy
without a PIC, the Board assessed a fine of $15,000 plus administrative
and investigative costs.
Vital Care of Miss-Lou, Inc, dba Vital Care (PHY.006301): For
its failure to obtain a new pharmacy permit when the ownership
changed in 2012, and for the continued operation of the pharmacy
without its own valid pharmacy permit, the Board assessed
a fine of $5,000 plus administrative and investigative costs.
Tanya Lynnette Black (CPT.006606): Board accepted the
voluntary surrender of the credential, resulting in the active
suspension of the technician certificate for an indefinite period
of time, effective September 10, 2014.
Institutional Pharmacy Solutions, LLC, dba Institutional
Pharmacy Solutions (PHY.006424): For its improper possession
of prescription records dispensed by another pharmacy,
and for the improper reporting of prescription transaction data
to the state PMP, the Board assessed a fine of $25,000 plus
administrative and investigative costs.
OK Compounding, LLC, dba OK Compounding (PHY Applicant):
For dispensing over 180 prescriptions into Louisiana
without the required permit to do so, and for its resident state
pharmacy permit being placed on probation, the Board denied
the application and refused to issue the permit, and further,
permanently prohibited the acceptance of any future application
for a pharmacy permit, and furthermore, assessed a fine
of $5,000 plus administrative costs.
Crystal Tavaralynne Hobdy (CPT.008861): For her repeated
failure to disclose criminal history record information on
multiple renewal applications, the Board suspended the technician
certificate for three years and stayed the execution of the
suspension, then placed the certificate on probation for three
years, effective November 13, 2014, and further, assessed administrative
costs.
Randal Riverside Corporation dba Matlock Pharmacy
(PHY.006883): For dispensing over 900 prescriptions into
Louisiana without the required permit to do so, and for its
repeated denials of that activity, the Board suspended the
pharmacy permit for five years and stayed the execution of the
suspension, then placed the pharmacy permit on probation for
five years, effective November 13, 2014, and further, assessed
a fine of $50,000 plus administrative and investigative costs.
Medco Health Solutions of Willingboro, LLC, dba Medco
Health Solutions of Willingboro (PHY.004730): For its failure
to obtain a new pharmacy permit when the ownership changed
in 2009, and for the continued operation of the pharmacy without
its own valid pharmacy permit, the Board assessed a fine of
$20,000 plus administrative and investigative costs.Continued from page 4
Medco Health Solutions of Las Vegas, LLC, dba Medco Health
Solutions of Las Vegas (PHY.003521): For its failure to obtain
a new pharmacy permit when the ownership changed in 2009,
and for the continued operation of the pharmacy without its own
valid pharmacy permit, the Board assessed a fine of $20,000
plus administrative costs.
Medco Health Solutions of Fairfield, LLC, dba Medco Health
Solutions of Fairfield (PHY.004237): For its failure to obtain
a new pharmacy permit when the ownership changed in 2009,
and for the continued operation of the pharmacy without its own
valid pharmacy permit, the Board assessed a fine of $20,000
plus administrative costs.
Medco Health Solutions of Columbus West, Ltd, dba Medco
Health Solutions of Columbus West (PHY.003595): For its
failure to obtain a new pharmacy permit when the ownership
changed in 2009, and for the continued operation of the pharmacy
without its own valid pharmacy permit, the Board assessed
a fine of $20,000 plus administrative costs.
Medco Health Solutions of Hidden River, LLC, dba Medco
Health Solutions of Hidden River (PHY.004927): For its
failure to obtain a new pharmacy permit when the ownership
changed in 2009, and for the continued operation of the pharmacy
without its own valid pharmacy permit, the Board assessed
a fine of $20,000 plus administrative costs.
Medco Health Solutions of Texas, LLC, dba Medco Health
Solutions of Fort Worth (PHY.003606): For its failure to
obtain a new pharmacy permit when the ownership changed in
2009, and for the continued operation of the pharmacy without
its own valid pharmacy permit, the Board assessed a fine of
$20,000 plus administrative costs.
Medco Health Solutions of Columbus North, Ltd, dba Medco
Health Solutions of Dublin (PHY.004530): For its failure to
obtain a new pharmacy permit when the ownership changed in
2009, and for the continued operation of the pharmacy without
its own valid pharmacy permit, the Board assessed a fine of
$20,000 plus administrative costs.
Medco Health Solutions of Netpark, LLC, dba Medco Health
Solutions of Netpark (PHY.004853): For its failure to obtain
a new pharmacy permit when the ownership changed in 2009,
and for the continued operation of the pharmacy without its own
valid pharmacy permit, the Board assessed a fine of $20,000
plus administrative and investigative costs.
Medco Health Solutions of North Versailles, LLC, dba Medco
Health Solutions of North Versailles (PHY.003580): For its
failure to obtain a new pharmacy permit when the ownership
changed in 2009, and for the continued operation of the pharmacy
without its own valid pharmacy permit, the Board assessed
a fine of $20,000 plus administrative costs.
Tiffany Cathleen Luse Upshaw (PST.018936): Board granted
request for reinstatement of the previously suspended license,
then placed the license on probation for five years, effective
November 13, 2014, subject to certain terms enumerated in the
consent agreement.
Casey Ann Kendall (PST.017305): Board granted request for
probation modification, then removed all probationary terms
and restored the license to active and unrestricted status.
Edward John Rabalais (PST.009897): Board granted request for
probation modification, then removed all probationary terms and
restored the license to active and unrestricted status.
Bobby Trondell Thompson (PST.020854): Board approved application
for licensure by reciprocity, then placed the license on
probation for five years, effective November 13, 2014, subject to
certain terms enumerated in the consent agreement.
Lakyn Hope Manuel (CPT.009959): For her failure to disclose
criminal history record information on her most recent renewal
application, the Board assessed a fine of $250 plus administrative
costs.
Colin Michael Browder (CPT.010907): For his alleged diversion
of CS from his employer pharmacy, the Board revoked the
technician certificate, effective October 9, 2014, and further,
permanently prohibited the acceptance of any future application
for the reinstatement of the certificate, or for any other credential
issued by the Board.
Bonnie Irene Sherman (CPT.011152): For her failure to disclose
criminal history record information on her most recent renewal
application, the Board assessed a fine of $250 plus administrative
costs.
Cassandra Leticia Rochelle Thomas (CPT.006932): For her
failure to disclose criminal history record information on her
most recent renewal application, the Board assessed a fine of
$250 plus administrative costs.
Nicole Graham Russo (CPT.009361): For her failure to disclose
criminal history record information on her most recent renewal
application, the Board assessed a fine of $250 plus administrative
costs.
Jennifer Violet Gibson (CPT.010456): Board accepted the
voluntary surrender of the credential, resulting in the active
suspension of the technician certificate for an indefinite period
of time, effective November 5, 2014.
Myrna Lynn Williams (PST.013793): Board accepted the
voluntary surrender of the credential, resulting in the active
suspension of the license for an indefinite period of time, effective
September 2, 2014.
Jerry Samuel Adkins (PST.014585): Board accepted the voluntary
surrender of the credential, resulting in the active suspension
of the license for an indefinite period of time, effective
October 24, 2014.
Sara Lynn Henning (CPT.009568): Board accepted the voluntary
surrender of the credential, resulting in the active suspension
of the certificate for an indefinite period of time, effective
October 30, 2014.
During the same meeting, the Board granted conditional
approval for the reinstatement of an expired certificate for one
technician, pending satisfaction of certain terms enumerated in
his or her consent agreement. The Board also issued a letter of
reprimand to one pharmacist. Finally, the Board suspended the
controlled dangerous substance licenses for eight physicians whose
medical licenses were suspended by the Louisiana State Board of
Medical Examiners.
source
During its November 2014 meeting, the Board took final action
in the following matters.
Medical Arts Pharmacy Services, Inc, dba Medical Arts
Pharmacy (PHY Applicant): For its forgery of the name and
signature of the pharmacist-in-charge (PIC) on its application
for a pharmacy permit, the Board denied the application and
refused to issue the permit.
Louisiana CVS Pharmacy, LLC, dba CVS Pharmacy No. 5306
(PHY.005788 and CDS.039634): For its failure to appoint a
replacement PIC for 15 months, for the continued operation
of the pharmacy without a PIC, and for its fraudulent renewal
application, the Board suspended the pharmacy permit and
state CS license for two years and stayed the execution of the
suspension, then placed both credentials on probation for two
years, effective November 13, 2014, and further, assessed a fine
of $100,000 plus administrative and investigative costs.
Louisiana CVS Pharmacy, LLC, dba CVS Pharmacy No. 5612
(PHY.005769): For its failure to appoint a replacement PIC for
five months, and for the continued operation of the pharmacy
without a PIC, the Board assessed a fine of $25,000 plus administrative
and investigative costs.
Norman August Higginbotham (PST.015486): For his failure
to properly perform the required tasks as departing PIC of CVS
Pharmacy No. 5612, the Board issued a letter of reprimand, and
further, assessed a fine of $2,500 plus administrative costs.
Louisiana CVS Pharmacy, LLC, dba CVS Pharmacy No. 1939
(PHY.006316): For its failure to appoint a replacement PIC for
one month, and for the continued operation of the pharmacy
without a PIC, the Board assessed a fine of $15,000 plus administrative
and investigative costs.
Louisiana CVS Pharmacy, LLC, dba CVS Pharmacy No. 8999
(PHY.006285): For its failure to appoint a replacement PIC for
one month, and for the continued operation of the pharmacy
without a PIC, the Board assessed a fine of $15,000 plus administrative
and investigative costs.
Louisiana CVS Pharmacy, LLC, dba CVS Pharmacy No. 1017
(PHY.006018): For its failure to appoint a replacement PIC for
one month, and for the continued operation of the pharmacy
without a PIC, the Board assessed a fine of $15,000 plus administrative
and investigative costs.
Vital Care of Miss-Lou, Inc, dba Vital Care (PHY.006301): For
its failure to obtain a new pharmacy permit when the ownership
changed in 2012, and for the continued operation of the pharmacy
without its own valid pharmacy permit, the Board assessed
a fine of $5,000 plus administrative and investigative costs.
Tanya Lynnette Black (CPT.006606): Board accepted the
voluntary surrender of the credential, resulting in the active
suspension of the technician certificate for an indefinite period
of time, effective September 10, 2014.
Institutional Pharmacy Solutions, LLC, dba Institutional
Pharmacy Solutions (PHY.006424): For its improper possession
of prescription records dispensed by another pharmacy,
and for the improper reporting of prescription transaction data
to the state PMP, the Board assessed a fine of $25,000 plus
administrative and investigative costs.
OK Compounding, LLC, dba OK Compounding (PHY Applicant):
For dispensing over 180 prescriptions into Louisiana
without the required permit to do so, and for its resident state
pharmacy permit being placed on probation, the Board denied
the application and refused to issue the permit, and further,
permanently prohibited the acceptance of any future application
for a pharmacy permit, and furthermore, assessed a fine
of $5,000 plus administrative costs.
Crystal Tavaralynne Hobdy (CPT.008861): For her repeated
failure to disclose criminal history record information on
multiple renewal applications, the Board suspended the technician
certificate for three years and stayed the execution of the
suspension, then placed the certificate on probation for three
years, effective November 13, 2014, and further, assessed administrative
costs.
Randal Riverside Corporation dba Matlock Pharmacy
(PHY.006883): For dispensing over 900 prescriptions into
Louisiana without the required permit to do so, and for its
repeated denials of that activity, the Board suspended the
pharmacy permit for five years and stayed the execution of the
suspension, then placed the pharmacy permit on probation for
five years, effective November 13, 2014, and further, assessed
a fine of $50,000 plus administrative and investigative costs.
Medco Health Solutions of Willingboro, LLC, dba Medco
Health Solutions of Willingboro (PHY.004730): For its failure
to obtain a new pharmacy permit when the ownership changed
in 2009, and for the continued operation of the pharmacy without
its own valid pharmacy permit, the Board assessed a fine of
$20,000 plus administrative and investigative costs.Continued from page 4
Medco Health Solutions of Las Vegas, LLC, dba Medco Health
Solutions of Las Vegas (PHY.003521): For its failure to obtain
a new pharmacy permit when the ownership changed in 2009,
and for the continued operation of the pharmacy without its own
valid pharmacy permit, the Board assessed a fine of $20,000
plus administrative costs.
Medco Health Solutions of Fairfield, LLC, dba Medco Health
Solutions of Fairfield (PHY.004237): For its failure to obtain
a new pharmacy permit when the ownership changed in 2009,
and for the continued operation of the pharmacy without its own
valid pharmacy permit, the Board assessed a fine of $20,000
plus administrative costs.
Medco Health Solutions of Columbus West, Ltd, dba Medco
Health Solutions of Columbus West (PHY.003595): For its
failure to obtain a new pharmacy permit when the ownership
changed in 2009, and for the continued operation of the pharmacy
without its own valid pharmacy permit, the Board assessed
a fine of $20,000 plus administrative costs.
Medco Health Solutions of Hidden River, LLC, dba Medco
Health Solutions of Hidden River (PHY.004927): For its
failure to obtain a new pharmacy permit when the ownership
changed in 2009, and for the continued operation of the pharmacy
without its own valid pharmacy permit, the Board assessed
a fine of $20,000 plus administrative costs.
Medco Health Solutions of Texas, LLC, dba Medco Health
Solutions of Fort Worth (PHY.003606): For its failure to
obtain a new pharmacy permit when the ownership changed in
2009, and for the continued operation of the pharmacy without
its own valid pharmacy permit, the Board assessed a fine of
$20,000 plus administrative costs.
Medco Health Solutions of Columbus North, Ltd, dba Medco
Health Solutions of Dublin (PHY.004530): For its failure to
obtain a new pharmacy permit when the ownership changed in
2009, and for the continued operation of the pharmacy without
its own valid pharmacy permit, the Board assessed a fine of
$20,000 plus administrative costs.
Medco Health Solutions of Netpark, LLC, dba Medco Health
Solutions of Netpark (PHY.004853): For its failure to obtain
a new pharmacy permit when the ownership changed in 2009,
and for the continued operation of the pharmacy without its own
valid pharmacy permit, the Board assessed a fine of $20,000
plus administrative and investigative costs.
Medco Health Solutions of North Versailles, LLC, dba Medco
Health Solutions of North Versailles (PHY.003580): For its
failure to obtain a new pharmacy permit when the ownership
changed in 2009, and for the continued operation of the pharmacy
without its own valid pharmacy permit, the Board assessed
a fine of $20,000 plus administrative costs.
Tiffany Cathleen Luse Upshaw (PST.018936): Board granted
request for reinstatement of the previously suspended license,
then placed the license on probation for five years, effective
November 13, 2014, subject to certain terms enumerated in the
consent agreement.
Casey Ann Kendall (PST.017305): Board granted request for
probation modification, then removed all probationary terms
and restored the license to active and unrestricted status.
Edward John Rabalais (PST.009897): Board granted request for
probation modification, then removed all probationary terms and
restored the license to active and unrestricted status.
Bobby Trondell Thompson (PST.020854): Board approved application
for licensure by reciprocity, then placed the license on
probation for five years, effective November 13, 2014, subject to
certain terms enumerated in the consent agreement.
Lakyn Hope Manuel (CPT.009959): For her failure to disclose
criminal history record information on her most recent renewal
application, the Board assessed a fine of $250 plus administrative
costs.
Colin Michael Browder (CPT.010907): For his alleged diversion
of CS from his employer pharmacy, the Board revoked the
technician certificate, effective October 9, 2014, and further,
permanently prohibited the acceptance of any future application
for the reinstatement of the certificate, or for any other credential
issued by the Board.
Bonnie Irene Sherman (CPT.011152): For her failure to disclose
criminal history record information on her most recent renewal
application, the Board assessed a fine of $250 plus administrative
costs.
Cassandra Leticia Rochelle Thomas (CPT.006932): For her
failure to disclose criminal history record information on her
most recent renewal application, the Board assessed a fine of
$250 plus administrative costs.
Nicole Graham Russo (CPT.009361): For her failure to disclose
criminal history record information on her most recent renewal
application, the Board assessed a fine of $250 plus administrative
costs.
Jennifer Violet Gibson (CPT.010456): Board accepted the
voluntary surrender of the credential, resulting in the active
suspension of the technician certificate for an indefinite period
of time, effective November 5, 2014.
Myrna Lynn Williams (PST.013793): Board accepted the
voluntary surrender of the credential, resulting in the active
suspension of the license for an indefinite period of time, effective
September 2, 2014.
Jerry Samuel Adkins (PST.014585): Board accepted the voluntary
surrender of the credential, resulting in the active suspension
of the license for an indefinite period of time, effective
October 24, 2014.
Sara Lynn Henning (CPT.009568): Board accepted the voluntary
surrender of the credential, resulting in the active suspension
of the certificate for an indefinite period of time, effective
October 30, 2014.
During the same meeting, the Board granted conditional
approval for the reinstatement of an expired certificate for one
technician, pending satisfaction of certain terms enumerated in
his or her consent agreement. The Board also issued a letter of
reprimand to one pharmacist. Finally, the Board suspended the
controlled dangerous substance licenses for eight physicians whose
medical licenses were suspended by the Louisiana State Board of
Medical Examiners.
source
Whole Lot of Changes to Pharmacy Law Happening in Louisiana Including News Rules Relating to Compounding
Status Report on Rulemaking Activities
(15-01-480)
The Board continues to promulgate new rules as well as revisions
to existing rules. For its clients who have provided their
email addresses, the Board sends electronic Notices of Rulemaking
Activity about these issues.
♦ Regulatory Project 2014-3 ~ Pharmacy Records. The Board
published its Notice of Intent to substantially revise its rules
for pharmacy record keeping on March 20, 2014. After two
public hearings and some revisions to the original proposal,
the Board published the final rule in November 2014, with a
delayed effective date of January 1, 2015. The rule substantially
revised and updated Subchapter B – Pharmacy Records of
Chapter 11 – Pharmacies of the Board’s rules. In addition, the
project made related changes to the records section of Chapter
12 – Automated Medication Systems as well as §1509 – Drug
Distribution Control of Chapter 15 – Hospital Pharmacy.
The rule establishes the standard for positive identification (as
opposed to simple identification) to identify an individual who
prescribes, dispenses, or administers a prescription drug. The
rule then outlines the types of records that require positive identification
and those for which simple identification is sufficient.
The rule identifies two general types of pharmacy dispensing
information systems and requires pharmacies to use one or the
other. Regardless of the type used, the rule identifies the data
elements that must be maintained in the pharmacy dispensing
information system. The rule describes the requirement for
backup and support systems, procedures for purging information
systems, and maintaining audit trails, as well as data
retention requirements and timelines for data production when
requested by the Board. The rule also describes requirements
for the filing of prescription forms and certain allowances for
prescriptions received by facsimile, computer facsimile, and
in electronic format.
♦ Regulatory Project 2014-4 ~ Pharmacy Compounding. During
its August 2014 meeting, the Board received a recommendation
from its Regulation Revision Committee taking note of the
recently enacted federal legislation (Drug Quality and Security
Act of 2013) that limits state-licensed pharmacies to compounding
activities in response to patient-specific prescriptions, with
no authority for compounding preparations in response to purchase
orders from practitioners. The Board voted to allow the
previous emergency rule to expire on August 4, and further,
voted to issue a new emergency rule that became effective on
August 8. That emergency rule seeks to harmonize the Board’s
rule with the recently enacted federal legislation. The Board
republished that emergency rule in December 2014, while pursuing
the promulgation of a permanent rule. The Board completed
that process and will publish the final rule on January 20, 2015.
(15-01-480)
The Board continues to promulgate new rules as well as revisions
to existing rules. For its clients who have provided their
email addresses, the Board sends electronic Notices of Rulemaking
Activity about these issues.
♦ Regulatory Project 2014-3 ~ Pharmacy Records. The Board
published its Notice of Intent to substantially revise its rules
for pharmacy record keeping on March 20, 2014. After two
public hearings and some revisions to the original proposal,
the Board published the final rule in November 2014, with a
delayed effective date of January 1, 2015. The rule substantially
revised and updated Subchapter B – Pharmacy Records of
Chapter 11 – Pharmacies of the Board’s rules. In addition, the
project made related changes to the records section of Chapter
12 – Automated Medication Systems as well as §1509 – Drug
Distribution Control of Chapter 15 – Hospital Pharmacy.
The rule establishes the standard for positive identification (as
opposed to simple identification) to identify an individual who
prescribes, dispenses, or administers a prescription drug. The
rule then outlines the types of records that require positive identification
and those for which simple identification is sufficient.
The rule identifies two general types of pharmacy dispensing
information systems and requires pharmacies to use one or the
other. Regardless of the type used, the rule identifies the data
elements that must be maintained in the pharmacy dispensing
information system. The rule describes the requirement for
backup and support systems, procedures for purging information
systems, and maintaining audit trails, as well as data
retention requirements and timelines for data production when
requested by the Board. The rule also describes requirements
for the filing of prescription forms and certain allowances for
prescriptions received by facsimile, computer facsimile, and
in electronic format.
♦ Regulatory Project 2014-4 ~ Pharmacy Compounding. During
its August 2014 meeting, the Board received a recommendation
from its Regulation Revision Committee taking note of the
recently enacted federal legislation (Drug Quality and Security
Act of 2013) that limits state-licensed pharmacies to compounding
activities in response to patient-specific prescriptions, with
no authority for compounding preparations in response to purchase
orders from practitioners. The Board voted to allow the
previous emergency rule to expire on August 4, and further,
voted to issue a new emergency rule that became effective on
August 8. That emergency rule seeks to harmonize the Board’s
rule with the recently enacted federal legislation. The Board
republished that emergency rule in December 2014, while pursuing
the promulgation of a permanent rule. The Board completed
that process and will publish the final rule on January 20, 2015.
Whole Lot of Changes Happening in Montana Relating to Pharmacy Law
Proposed Rule Notice
On October 23, 2014, the Montana Board of Pharmacy published a
proposed rule, Montana Administrative Rule Notice No. 24-174-65, to
amend and transfer existing rules related to sterile compounding, interns,
technicians, prescriptions, and the Montana Prescription Drug Registry
(MPDR) program, and to adopt a new rule related to quality assurance.
The notice is available online at www.pharmacy.mt.gov (click on “Regulations,”
then “Rule Notices”).
A public hearing was held on November 13, 2014, and comments were
due November 21, 2014. At the next Board meeting on January 9, 2015,
the Board will discuss the comments received and consider action steps
for final adoption and publication.
General summaries of the proposed rules are listed below.
Proposed Amendments
♦ 24.174.301 Definitions – Updates and adds several new definitions
to accurately reflect current sterile compounding terminology and
standards of practice.
♦ 24.174.411 Pharmacist Meal/Rest Breaks – Clarifies that a pharmacist
may also authorize an intern to remain in the prescription department.
♦ 24.174.602 Internship Requirements – Allows interns additional time
to notify the Board of any address change, similar to the time allotted
to a pharmacist preceptor.
♦ 24.174.701 Registration Requirements – Allows technicians-intraining
additional time to notify the Board of any address change,
similar to the time allotted to a pharmacist preceptor.
♦ 24.174.903 Patient Counseling – Removes the effective date of the
patient counseling area requirements, which became effective in 2003.
♦ 24.174.1101 Personnel – Amends the rule by including additional
requirements when compounding drugs that align with standards
of pharmacy practice, as published by United States Pharmacopeial
Convention (USP).
♦ 24.174.1111 Drug Distribution and Control in an Institutional
Facility – Amends and clarifies the rule regarding requirements for
information that must be obtained and maintained.
♦ 24.174.1115 Use of Contingency Kits in Certain Institutional Facilities
– Clarifies that contingency kit contents and related records must
be made available for Board inspection.
♦ 24.174.1704 Requirements for Submitting Prescription Registry
Information to the Board – Clarifies which pharmacies must report
information to the MPDR and when that information must be reported.
Additionally, the proposed amendment clarifies requirements for
resubmitting corrected data and clarifies the process for submitting
zero reports.
♦ 24.174.2403 Legal Suspension or Revocation – Clarifies that interns
cannot work without supervision.
Proposed Amendments and Transfers
♦ 24.174.510 Prescription Requirements – Defines chart order and
transfers the rule from Subchapter 5 regarding Licensing to Subchapter
8 regarding Pharmacies.
♦ 24.174.514 Transfer of Prescriptions – Amends the process for
transferring prescriptions, including the involvement of interns in
current pharmacy practice, limiting the transfer of prescriptions for
controlled substances (CS), requiring pharmacies to maintain retrievable
audit trails, and removing the requirement that pharmacists obtain
and maintain forms when patients object to electronic transmission
of their records. Additionally, the proposed rule change transfers the
rule from Subchapter 5 regarding Licensing to Subchapter 8 regarding
Pharmacies.
♦ 24.174.523 Transmission of Prescriptions by Electronic Means –
Strikes the word “only” with regard to when a pharmacist may directly
dispense a Schedule II CS pursuant to a prescription. Additionally,
allows for a prescription by electronic means. The proposed rule also
transfers the rule from Subchapter 5 regarding Licensing to Subchapter
8 regarding Pharmacies. (Note: The 2015 Montana Legislative Session
will be considering statutory revisions seeking full electronic prescribing
authority for CS in Montana.)
♦ 24.174.1121 Sterile Products – Updates drug compounding
standards to align with standards of pharmacy practice as published
by USP. Additionally, the proposed rule change transfers the rule from
Subchapter 11 regarding Institutional Pharmacies to Subchapter 8
regarding Pharmacies.
Proposed New Rule
♦ New Rule I Quality Assurance Program Requirements – Establishes
a requirement for pharmacies to implement quality assurance programs.
Proposed Transfer of Rules from Subchapter 5 Regarding
Licensing to Subchapter 8 Regarding Pharmacies
♦ 24.174.511 (Labeling for Prescriptions), 512 (Records of Dispensing),
513 (Copy of Prescription), 515 (Emergency Prescription Refills), 520
(Prescription Required for Schedule V), 521 (Returned Prescription),
and 522 (Alternate Delivery of Prescriptions).
2015 Montana Legislative Session
The 64th Session of the Montana Legislature starts in Helena, MT, on
January 5, 2015, and is scheduled to end by April 27, 2015. Information
about legislators, bills, committees, and the Session activities is available
online at http://leg.mt.gov/css/default.asp. As of November 2014, there
have been two bills introduced that would impact the Board:
♦ Senate Bill 7, Revise and extend the prescription drug registry fee; and
♦ Senate Bill 8, Allow electronic prescribing of controlled substances
prescriptions.
In addition, information about the 2013 Senate Joint Resolution 20, an
interim study on prescription drug abuse and prevention in Montana, as well as the work of the Children, Families, Health, & Human Services
Interim Committee 2013-2014 is available online at http://leg.mt.gov/css/
Committees/Interim/2013-2014/Children-Family/default.asp. The Board
provided several presentations and a report about the MPDR program
throughout the 2013-2014 Interim Committee discussions.
quoted from here
On October 23, 2014, the Montana Board of Pharmacy published a
proposed rule, Montana Administrative Rule Notice No. 24-174-65, to
amend and transfer existing rules related to sterile compounding, interns,
technicians, prescriptions, and the Montana Prescription Drug Registry
(MPDR) program, and to adopt a new rule related to quality assurance.
The notice is available online at www.pharmacy.mt.gov (click on “Regulations,”
then “Rule Notices”).
A public hearing was held on November 13, 2014, and comments were
due November 21, 2014. At the next Board meeting on January 9, 2015,
the Board will discuss the comments received and consider action steps
for final adoption and publication.
General summaries of the proposed rules are listed below.
Proposed Amendments
♦ 24.174.301 Definitions – Updates and adds several new definitions
to accurately reflect current sterile compounding terminology and
standards of practice.
♦ 24.174.411 Pharmacist Meal/Rest Breaks – Clarifies that a pharmacist
may also authorize an intern to remain in the prescription department.
♦ 24.174.602 Internship Requirements – Allows interns additional time
to notify the Board of any address change, similar to the time allotted
to a pharmacist preceptor.
♦ 24.174.701 Registration Requirements – Allows technicians-intraining
additional time to notify the Board of any address change,
similar to the time allotted to a pharmacist preceptor.
♦ 24.174.903 Patient Counseling – Removes the effective date of the
patient counseling area requirements, which became effective in 2003.
♦ 24.174.1101 Personnel – Amends the rule by including additional
requirements when compounding drugs that align with standards
of pharmacy practice, as published by United States Pharmacopeial
Convention (USP).
♦ 24.174.1111 Drug Distribution and Control in an Institutional
Facility – Amends and clarifies the rule regarding requirements for
information that must be obtained and maintained.
♦ 24.174.1115 Use of Contingency Kits in Certain Institutional Facilities
– Clarifies that contingency kit contents and related records must
be made available for Board inspection.
♦ 24.174.1704 Requirements for Submitting Prescription Registry
Information to the Board – Clarifies which pharmacies must report
information to the MPDR and when that information must be reported.
Additionally, the proposed amendment clarifies requirements for
resubmitting corrected data and clarifies the process for submitting
zero reports.
♦ 24.174.2403 Legal Suspension or Revocation – Clarifies that interns
cannot work without supervision.
Proposed Amendments and Transfers
♦ 24.174.510 Prescription Requirements – Defines chart order and
transfers the rule from Subchapter 5 regarding Licensing to Subchapter
8 regarding Pharmacies.
♦ 24.174.514 Transfer of Prescriptions – Amends the process for
transferring prescriptions, including the involvement of interns in
current pharmacy practice, limiting the transfer of prescriptions for
controlled substances (CS), requiring pharmacies to maintain retrievable
audit trails, and removing the requirement that pharmacists obtain
and maintain forms when patients object to electronic transmission
of their records. Additionally, the proposed rule change transfers the
rule from Subchapter 5 regarding Licensing to Subchapter 8 regarding
Pharmacies.
♦ 24.174.523 Transmission of Prescriptions by Electronic Means –
Strikes the word “only” with regard to when a pharmacist may directly
dispense a Schedule II CS pursuant to a prescription. Additionally,
allows for a prescription by electronic means. The proposed rule also
transfers the rule from Subchapter 5 regarding Licensing to Subchapter
8 regarding Pharmacies. (Note: The 2015 Montana Legislative Session
will be considering statutory revisions seeking full electronic prescribing
authority for CS in Montana.)
♦ 24.174.1121 Sterile Products – Updates drug compounding
standards to align with standards of pharmacy practice as published
by USP. Additionally, the proposed rule change transfers the rule from
Subchapter 11 regarding Institutional Pharmacies to Subchapter 8
regarding Pharmacies.
Proposed New Rule
♦ New Rule I Quality Assurance Program Requirements – Establishes
a requirement for pharmacies to implement quality assurance programs.
Proposed Transfer of Rules from Subchapter 5 Regarding
Licensing to Subchapter 8 Regarding Pharmacies
♦ 24.174.511 (Labeling for Prescriptions), 512 (Records of Dispensing),
513 (Copy of Prescription), 515 (Emergency Prescription Refills), 520
(Prescription Required for Schedule V), 521 (Returned Prescription),
and 522 (Alternate Delivery of Prescriptions).
2015 Montana Legislative Session
The 64th Session of the Montana Legislature starts in Helena, MT, on
January 5, 2015, and is scheduled to end by April 27, 2015. Information
about legislators, bills, committees, and the Session activities is available
online at http://leg.mt.gov/css/default.asp. As of November 2014, there
have been two bills introduced that would impact the Board:
♦ Senate Bill 7, Revise and extend the prescription drug registry fee; and
♦ Senate Bill 8, Allow electronic prescribing of controlled substances
prescriptions.
In addition, information about the 2013 Senate Joint Resolution 20, an
interim study on prescription drug abuse and prevention in Montana, as well as the work of the Children, Families, Health, & Human Services
Interim Committee 2013-2014 is available online at http://leg.mt.gov/css/
Committees/Interim/2013-2014/Children-Family/default.asp. The Board
provided several presentations and a report about the MPDR program
throughout the 2013-2014 Interim Committee discussions.
quoted from here
Thursday, January 1, 2015
Oklahoma Board of Pharmacy Revokes Pharmacists License for aking or filing a report or record that he knew or should have known to be false; billing or charging for quantities greater than delivered or for a brand when a generic or a compounded product is dispensed; and submitting fraudulent billing or reports to a third-party payer of prescription drugs
Guy Sheneman, DPh #9806 – Case No. 1295: Admitted
to guilt on 45 counts, including making or filing a report
or record that he knew or should have known to be false;
billing or charging for quantities greater than delivered
or for a brand when a generic or a compounded product
is dispensed; and submitting fraudulent billing or reports
to a third-party payer of prescription drugs (for example,
intentional billing for Aggrenox® name brand when aspirin
81 mg was dispensed; billing for Flovent® HFA when
Ventolin® HFA was dispensed; billing for Abilify® when
n-acetylcysteine was dispensed; billing for Lunesta® when
zolpidem was dispensed). During the partial period audited
by the Board, there was an aggregate overbilling of about
$351,496.85. Respondent agrees that he will never again
own a pharmacy, an interest in a pharmacy, or an interest
in an entity that owns a pharmacy. Respondent agrees to
never work in a pharmacy again in any position, whether
paid or unpaid. Revoked.
quoted from here
to guilt on 45 counts, including making or filing a report
or record that he knew or should have known to be false;
billing or charging for quantities greater than delivered
or for a brand when a generic or a compounded product
is dispensed; and submitting fraudulent billing or reports
to a third-party payer of prescription drugs (for example,
intentional billing for Aggrenox® name brand when aspirin
81 mg was dispensed; billing for Flovent® HFA when
Ventolin® HFA was dispensed; billing for Abilify® when
n-acetylcysteine was dispensed; billing for Lunesta® when
zolpidem was dispensed). During the partial period audited
by the Board, there was an aggregate overbilling of about
$351,496.85. Respondent agrees that he will never again
own a pharmacy, an interest in a pharmacy, or an interest
in an entity that owns a pharmacy. Respondent agrees to
never work in a pharmacy again in any position, whether
paid or unpaid. Revoked.
quoted from here
Oklahoma Board of Pharmacy Reminds of Specific Regulations Regarding Clinical Drug Studies
15.03. Clinical Drug Studies
The federal government has very specific regulations
that deal with drug studies involving human patients. These
regulations include requirements and documentation for
informed consent by the study participants. In most cases,
each clinical trial in the US must be approved and monitored
by an Institutional Review Board (IRB) to ensure that the
risks are minimal and are worth any potential benefits. An
IRB is an independent committee that consists of physicians,
statisticians, and members of the community who ensure that
clinical trials are ethical and that the rights of participants
are protected. Federal regulation requires all institutions in
the US that conduct or support biomedical research involving
people to have an IRB initially approve and periodically
review the research. A clinical study is led by a principal
investigator, who is often a doctor. Members of the research
team regularly monitor the participants’ health to determine
the study’s safety and effectiveness. Charging patients for
medications in a clinical trial is governed by 21 CFR 312.8(a)
and (b). In most cases, a study sponsor must obtain prior
written authorization from Food and Drug Administration
to charge for drugs used in an investigational drug study,
and under 21 CFR 312.8(d)(1), a sponsor may recover only
the direct costs of making its investigational drug available.
Pharmacies and pharmacists must exercise caution in
their involvement in a business model that purports to be a
“study” or “survey” involving human patients, and ensure
that if they are involved in such a study, they have followed
all applicable federal regulations. In the absence of a real
“study,” a pharmacist or pharmacy that pays a prescriber to
write prescriptions as a study director or medical advisor
may be in violation of Board regulations and rules as well as
both state and federal anti-kickback statutes. Additionally,
prescribers who are requested to be participants in a drug
“study” should request and review a copy of the official IRB
study protocols and applicable federal study approvals before
accepting a role in the study. In the absence of following the
federal regulations that apply to human drug studies, prescribers
may also be charged with state and federal law violations
quoted from here
The federal government has very specific regulations
that deal with drug studies involving human patients. These
regulations include requirements and documentation for
informed consent by the study participants. In most cases,
each clinical trial in the US must be approved and monitored
by an Institutional Review Board (IRB) to ensure that the
risks are minimal and are worth any potential benefits. An
IRB is an independent committee that consists of physicians,
statisticians, and members of the community who ensure that
clinical trials are ethical and that the rights of participants
are protected. Federal regulation requires all institutions in
the US that conduct or support biomedical research involving
people to have an IRB initially approve and periodically
review the research. A clinical study is led by a principal
investigator, who is often a doctor. Members of the research
team regularly monitor the participants’ health to determine
the study’s safety and effectiveness. Charging patients for
medications in a clinical trial is governed by 21 CFR 312.8(a)
and (b). In most cases, a study sponsor must obtain prior
written authorization from Food and Drug Administration
to charge for drugs used in an investigational drug study,
and under 21 CFR 312.8(d)(1), a sponsor may recover only
the direct costs of making its investigational drug available.
Pharmacies and pharmacists must exercise caution in
their involvement in a business model that purports to be a
“study” or “survey” involving human patients, and ensure
that if they are involved in such a study, they have followed
all applicable federal regulations. In the absence of a real
“study,” a pharmacist or pharmacy that pays a prescriber to
write prescriptions as a study director or medical advisor
may be in violation of Board regulations and rules as well as
both state and federal anti-kickback statutes. Additionally,
prescribers who are requested to be participants in a drug
“study” should request and review a copy of the official IRB
study protocols and applicable federal study approvals before
accepting a role in the study. In the absence of following the
federal regulations that apply to human drug studies, prescribers
may also be charged with state and federal law violations
quoted from here
Beware of your Requirements as an Oklahoma Licensed PIC--Phantom PICS Will Not be Tolerated
15.02. Phantom PICs
The Board has received several questions from Oklahomalicensed
pharmacists who have been approached by outof-state
pharmacies asking them to be employed as their
pharmacist-in-charge (PIC) for their Oklahoma license, and
suggesting to the pharmacists that they do not have to actually
work at the pharmacy. A term for this might be an “absent”
or “phantom” PIC. This situation is no doubt occurring more
frequently due to the new requirement that nonresident pharmacies
that do sterile compounding must have an Oklahomalicensed
PIC. In one case, the Oklahoma-licensed pharmacist
was not even living in the United States at the time of the
employment offer; the pharmacy just wanted a pharmacist
with an Oklahoma license to sign its application or renewal
in a fraudulent attempt to meet the legal requirement. The
required PIC duties for an Oklahoma-licensed pharmacist
include accepting the full responsibility of all aspects of the
pharmacy’s operation, responsibility for controlled and noncontrolled
drugs in the pharmacy, as well as
(A) supervision of all employees as they relate to the
practice of pharmacy;
(B) establishment of policies and procedures for safekeeping
of pharmaceuticals that satisfy Board requirements,
including security provisions when the
pharmacy is closed;
(C) maintaining a proper record-keeping system for the
purchase, sale, delivery, possession, storage, and
safekeeping of drugs;
(D) proper display of all licenses;
(E) annual controlled drug inventory; and
(F) maintenance of prescription files.
Notably, OAC 535:15-3-2(b)(4) states: “A pharmacy
manager shall work sufficient hours in the pharmacy to exercise
control and meet the responsibilities of the pharmacy
manager.”
OAC 535:15-3-2(c)(1) states: “Where the actual identity
of the filler of a prescription is not determinable, the manager
of the pharmacy and the pharmacy where the prescription was
filled will be the subject of any charges filed by the Board
of Pharmacy.” And OAC 535:15-3-2(c)(4) states that the
pharmacy manager must “[e]stablish and maintain effective
controls against the diversion of prescription drugs into other
than legitimate medical, scientific, or industrial channels as
provided by federal, state or local laws or rules.”
It would not be possible for a PIC to exercise and fulfill
these responsibilities without being physically present in the
pharmacy a substantial amount of time. Keep in mind the
legal aspects of the responsibilities that are assumed if you
are approached by a pharmacy for a position as “phantom”
or “absent” PIC
quoted from here
The Board has received several questions from Oklahomalicensed
pharmacists who have been approached by outof-state
pharmacies asking them to be employed as their
pharmacist-in-charge (PIC) for their Oklahoma license, and
suggesting to the pharmacists that they do not have to actually
work at the pharmacy. A term for this might be an “absent”
or “phantom” PIC. This situation is no doubt occurring more
frequently due to the new requirement that nonresident pharmacies
that do sterile compounding must have an Oklahomalicensed
PIC. In one case, the Oklahoma-licensed pharmacist
was not even living in the United States at the time of the
employment offer; the pharmacy just wanted a pharmacist
with an Oklahoma license to sign its application or renewal
in a fraudulent attempt to meet the legal requirement. The
required PIC duties for an Oklahoma-licensed pharmacist
include accepting the full responsibility of all aspects of the
pharmacy’s operation, responsibility for controlled and noncontrolled
drugs in the pharmacy, as well as
(A) supervision of all employees as they relate to the
practice of pharmacy;
(B) establishment of policies and procedures for safekeeping
of pharmaceuticals that satisfy Board requirements,
including security provisions when the
pharmacy is closed;
(C) maintaining a proper record-keeping system for the
purchase, sale, delivery, possession, storage, and
safekeeping of drugs;
(D) proper display of all licenses;
(E) annual controlled drug inventory; and
(F) maintenance of prescription files.
Notably, OAC 535:15-3-2(b)(4) states: “A pharmacy
manager shall work sufficient hours in the pharmacy to exercise
control and meet the responsibilities of the pharmacy
manager.”
OAC 535:15-3-2(c)(1) states: “Where the actual identity
of the filler of a prescription is not determinable, the manager
of the pharmacy and the pharmacy where the prescription was
filled will be the subject of any charges filed by the Board
of Pharmacy.” And OAC 535:15-3-2(c)(4) states that the
pharmacy manager must “[e]stablish and maintain effective
controls against the diversion of prescription drugs into other
than legitimate medical, scientific, or industrial channels as
provided by federal, state or local laws or rules.”
It would not be possible for a PIC to exercise and fulfill
these responsibilities without being physically present in the
pharmacy a substantial amount of time. Keep in mind the
legal aspects of the responsibilities that are assumed if you
are approached by a pharmacy for a position as “phantom”
or “absent” PIC
quoted from here
]Introduction to Pharmacy Practice
T]Introduction to Pharmacy Practice - ASHP
www.ashp.org/.../chpt-2...
American Society of Health‑System Pharmacists
Are Pharmacy Schools the New Law Schools? |
Are Pharmacy Schools the New Law Schools? | Erin L ...
https://www.linkedin.com/.../20140805004233-7180835-are-p...LinkedInAug 5, 2014 - If you're not following what is happening in law schools right now, it's not ... like a law review–by the students in healthcare–not professors.
Third Question of the Day January 1, 2015 The Washington Post Article linked below mentioned states that were cracking down on compounding pharmacies. How many state boards of pharmacy followed up and disciplined compounding pharmacies that were resident pharmacies who haave been disciplined by other states? If readers know of examples where a compounding pharmacy was disciplined in one state such as Colorado but a resident of another states such as Arizona or Texas and the resident state board of pharmacy took no action please comment. Are these states lacking in authority, resources, both, or just on willing to take action?
Passing synthetic drug law priority for East Texas legislators
http://www.news-journal.com/news/local/passing-synthetic-drug-law-priority-for-east-texas-l...
Dec 14, 2014 ... Rusk County's state representative said he plans to lead the House charge against synthetic drugs in the legislative session that begins next ...
Lawmakers seek solutions to prescription drug epidemic
Lawmakers seek solutions to prescription drug epidemic
Texas legislators seeking an antidote for prescription drug abuse are expected to propose that doctors be encouraged — but not required, as some have urged — to use an online database that can identify patients who are “doctor shopping” for drugs.
Second Question of the Day January 1, 2015 Aren't the advertisements and notices stating there is a "right" or "entitlement" to compounded medications totally contrary to the law that says compounded medications are based on need? If we have a "right" or "entitlement" to drugs of choice what does this do to the laws regarding illegal substances? If there are no or should be no federal regulations of compounded drugs and we have a "right" to them according to these advertisements then does that "individual right" trump the health and safety of the public? Where do compounders draw the line or is there any line at all in their opinion? Are is it simply their right as compounders to make compounded medications and our right at US citizens to use compounded medications if we choose--even if untested, ineffective, and could cause harm to pets or humans? Will the new group of compounding pharmacist emerging who do not like the current messages advocated and who want compounding to based solely on legitimate need and not on entitlement theory be able to change the profession?
Question of the Day January 1, 2015 IACP and others continue to advocate that the DQSA and the FDA have hindered treatment options because traditional compounding pharmacies cannot provide office use compounding. Very few states allow office use compounding. How have all the states that do not allow office use compounding been able to function for all the years prior to the DQSA? Why hasn't the focus been on changing all these state laws in the past? And why haven't states changed these laws if compounded office use is so essential?
Washington State Health Care Authority Policy on Compounded Drugs Effective January 1, 2015
Prescription Drug Program Provider Guide - Health Care ... 
www.hca.wa.gov/medicaid/billing/.../prescription_drug_program_bi.pdf
Important Comment from Reader Regarding DQSA working....
A regulatory framework is only as effective as the agency enforcing it. Practically all of the nation's 50,000+ community pharmacies, together with the thousands more hospital and clinic pharmacies, engage in some level of compounding, at least occasionally. FDA simply lacks the personnel, infrastructure, and institutional expertise to operate at this level.
Further, FDA oversight is not a panacea. FDA's track record, even with commercially manufactured drugs, is ... mixed: Thalidimide, Vioxx, Heparin, Crestor, Duract, Pisocor, Rezulin, Baycol, Accutane, to name a few.
And state enforcement is not "less" these days. Many states have tightened regulations and more importantly, practically every state has gotten more serious about enforcement and (especially) inspections. Why? Mostly because state pharmacy boards understand FDA's limited front-line capabilities.
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