Showing posts with label proposed legislation. Show all posts
Showing posts with label proposed legislation. Show all posts

Wednesday, March 6, 2013

Bill Introduced in Texas Allowing Out-of-State Inspections

83R10338 MAW-F
 
 By: Van de PutteS.B. No. 1100
 
 
 
A BILL TO BE ENTITLED
 
AN ACT
 relating to the licensing and inspection of certain out-of-state
 pharmacies by the Texas State Board of Pharmacy; authorizing fees.
        BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
        SECTION 1.  Subchapter B, Chapter 556, Occupations Code, is
 amended by adding Section 556.0551 to read as follows:
        Sec. 556.0551.  INSPECTION OF LICENSED OUT-OF-STATE
 PHARMACY. (a) The board may conduct a random inspection of a
 pharmacy that holds a Class E pharmacy license and that compounds
 sterile prescription drugs for delivery to patients in this state
 as necessary to ensure compliance with the safety standards and
 other requirements of this subtitle and board rules.
        (b)  The board by rule shall set fees in amounts reasonable
 and necessary to cover the costs incurred by the board in inspecting
 a pharmacy as provided by Subsection (a).
        SECTION 2.  Section 560.052, Occupations Code, is amended by
 amending Subsection (c) and adding Subsection (g) to read as
 follows:
        (c)  To qualify for a Class E pharmacy license, an applicant,
 in addition to satisfying the other requirements of this chapter,
 must provide to the board:
              (1)  evidence that the applicant holds a pharmacy
 license, registration, or permit in good standing issued by the
 state in which the pharmacy is located;
              (2)  the name of the owner and pharmacist-in-charge of
 the pharmacy for service of process;
              (3)  evidence of the applicant's ability to provide to
 the board a record of a prescription drug order dispensed by the
 applicant to a resident of this state not later than 72 hours after
 the time the board requests the record;
              (4)  an affidavit by the pharmacist-in-charge that
 states that the pharmacist has read and understands the laws and
 rules relating to a Class E pharmacy;
              (5)  proof of creditworthiness; and
              (6)  except as provided by Subsection (f) or (g), an
 inspection report issued:
                    (A)  not more than two years before the date the
 license application is received; and
                    (B)  by the pharmacy licensing board in the state
 of the pharmacy's physical location[, except as provided by
 Subsection (f)].
        (g)  A Class E pharmacy license may not be issued to a
 pharmacy that compounds sterile prescription drugs for delivery to
 patients in this state unless the pharmacy has been inspected by the
 board to ensure the pharmacy meets the safety standards and other
 requirements of this subtitle and board rules. The board by rule
 shall set fees in amounts reasonable and necessary to cover the
 costs incurred by the board in inspecting an applicant as required
 by this subsection.
        SECTION 3.  Not later than November 1, 2013, the Texas State
 Board of Pharmacy shall adopt rules as required by Section
 556.0551, Occupations Code, as added by this Act, and Section
 560.052, Occupations Code, as amended by this Act.
        SECTION 4.  Section 560.052, Occupations Code, as amended by
 this Act, applies only to an application for a pharmacy license
 submitted to the Texas State Board of Pharmacy on or after the
 effective date of this Act. An application submitted before the
 effective date of this Act is governed by the law in effect on the
 date the application was submitted, and the former law is continued
 in effect for that purpose.
        SECTION 5.  This Act takes effect September 1, 2013.

Tuesday, March 5, 2013

TN drug compounding bill loses safeguard Meningitis culprit broke the same rule this bill would erase

March 5, 2013

Six months after moldy medicine caused an outbreak of a deadly new form of meningitis, Congress does not have a single bill before it to improve regulation of compounding pharmacies, and the only legislation proposed in Tennessee would strip away an important safeguard.
The one proposal pending before the Tennessee General Assembly would eliminate the requirement that compounded drugs be prepared only with a patient-specific prescription.
New England Compounding Center, the maker of the moldy medicine, violated this requirement when it mass-produced and sold steroid drugs that were injected into people’s spines as a pain treatment, federal and state regulators have charged.
The sponsor of the state legislation, Sen. Ferrell Haile, R-Gallatin, is a pharmacist.
“Right now I cannot compound for more than one individual at a time,” Haile said. “That’s why we had all this stuff coming in from other states.”
The effort by Haile is in direct contrast to the situation in California, where the state pharmacy board and some legislators are working to eliminate an existing provision in California law that mirrors the provision in Haile’s bill.
Virginia Herold of the California Pharmacy Board said a pending bill would eliminate a so-called prescriber’s exemption allowing production of compounded drugs without patient-specific prescriptions under certain circumstances.
Traditionally, compounding was used by pharmacists to create a custom medication specifically for one patient.
continue reading here

Opinion March 5, 2013 Senate in Oklahoma approved Safe Compounding Act The Norman Transcript


NORMAN — By a vote of 42-0, the full Senate has approved my proposal to ensure that out-of-state compounding pharmacies doing business in Oklahoma are held to high standards of safety.
The Safe Compounding Act will require out-of-state compounding pharmacies that deliver, dispense or distribute prescription drugs in Oklahoma to submit an affidavit and pharmacy site inspection form to receive a license.
I was compelled to author this bill after learning about a tragic story in Massachusetts where a compounding pharmacy was linked to hundreds of cases of fungal meningitis and 23 deaths. Just four of 37 similar specialty pharmacies were able to pass surprise health inspections shortly after the story broke.
Under this bill, the Oklahoma Board of Pharmacy will be able to oversee pharmacies in other states that may not operate by the same stringent standards that ours do. 

Source found here

Thursday, February 28, 2013

Maryland Senate Hearing Set for 3/13/13 1:00 on Proposed Legislation Relating to Compounding


Requiring a sterile compounding facility to hold a sterile compounding permit issued by the State Board of Pharmacy before the sterile compounding facility may perform sterile compounding in the State; providing that a sterile compounding permit is required in addition to and does not replace other permits or licenses; requiring a sterile compounding facility that performs sterile compounding outside the State to hold a sterile compounding permit issued by the Board under specified circumstances; etc.







For more information see here

Wednesday, February 27, 2013

South Carolina Proposed Legislation Relating to Pharmacy Practice Act and Compounding


VERSIONS OF THIS BILL
12/18/2012
2/20/2013

(Text matches printed bills. Document has been reformatted to meet World Wide Web specifications.)
Indicates Matter Stricken
Indicates New Matter
COMMITTEE REPORT
February 20, 2013
H. 3161

Introduced by Reps. Spires and Toole
S. Printed 2/20/13--H.
Read the first time January 8, 2013.

            

THE COMMITTEE ON MEDICAL,

MILITARY, PUBLIC AND MUNICIPAL AFFAIRS
To whom was referred a Bill (H. 3161) to amend Section 40-43-30, Code of Laws of South Carolina, 1976, relating to definitions in the South Carolina Pharmacy Practice Act, so as to define additional terms, etc., respectfully

REPORT:
That they have duly and carefully considered the same and recommend that the same do pass with amendment:
Amend the bill, as and if amended, by deleting all after the enacting words and inserting:
/ SECTION    1.    Section 40-43-30 of the 1976 Code is amended to read:
"Section 40-43-30.    For purposes of this chapter:
(1)    'Administer' means the direct application of a drug or device pursuant to a lawful order of a practitioner to the body of a patient by injection, inhalation, ingestion, topical application, or any other means.
(2)    'Ante area' means an ISO 8 or greater area where personnel perform hand hygiene, garbing, and stage components. An ante area precedes a buffer area, provided:
(a)    a buffer area must be separated by a wall from an ante area if high-risk preparations are compounded; and
(b)    if only low-risk and medium-risk preparations are compounded, separating an ante room from a buffer area is recommended.

Friday, February 22, 2013

UPDATE and REPOST From Jan. 26, 2013 : New Legislation Proposed In Oklahoma: But What's The Point Without More Inspectors and Actual Enforcement?

See this post for update:  Bill has passed Senate and now goes to House for a vote.

State Senator and compounding pharmacist Rob Standridge pre-filed SB 522 bill in the Oklahoma Senate.  SB 522 as written provides: 

STATE OF OKLAHOMA
1st Session of the 54th Legislature (2013)
SENATE BILL 522 By: Standridge
AS INTRODUCED
An Act relating to nonresident pharmacies; requiring 
nonresident pharmacies to submit certain information 
in applications for license issuance or renewal; 
providing for certain fees; providing for 
codification; and providing an effective date.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 1.     NEW LAW     A new section of law to be codified 
in the Oklahoma Statutes as Section 355.3 of Title 59, unless there 
is created a duplication in numbering, reads as follows:
As used in this act:
1.  "Nonresident pharmacy" means any pharmacy located outside of 
this state which delivers, dispenses, or distributes by any method 
prescription drugs or devices to a user physically located in this 
state, in addition to the initial application or renewal form and 
other documents required for a pharmacy located in Oklahoma; and
2.  "Pharmacist-in-charge" means a professionally competent, 
legally qualified pharmacist responsible for compliance with all Req. No. 367 
Page 2
laws and regulations governing the operation of the respective 
pharmacy.
SECTION 2.     NEW LAW     A new section of law to be codified 
in the Oklahoma Statutes as Section 355.4 of Title 59, unless there 
is created a duplication in numbering, reads as follows:
A nonresident pharmacy, in addition to the initial application 
or renewal form and other documents required for a pharmacy located 
in Oklahoma, shall:
1.  Submit an affidavit signed by the pharmacist-in-charge that 
the pharmacy shall comply with non-sterile and sterile compounding 
standards of the newest edition of the United States Pharmacopeial 
and United States Food and Drug Administration Good Manufacturing 
Practices;
2. a. Submit a pharmacy site inspection form completed and 
signed within the previous eighteen (18) months by a 
person authorized by the pharmacy's resident state 
agency or board which is responsible for issuing 
pharmacy licenses,
b. Submit a pharmacy site inspection form completed and 
signed within the previous eighteen (18) months by a 
staff person employed by the Oklahoma State Board of 
Pharmacy and pay all costs incurred by the Board for 
completion of the inspection, orReq. No. 367 
Page 3
c. Submit an inspection report or certificate of 
approval, from an organization approved by the 
Oklahoma State Board of Pharmacy, which shall include 
the standards and procedures to which the pharmacy 
demonstrated compliance; and
3.  Pay an additional fee of One Hundred Dollars ($100.00) over 
and above the licensing and inspection fees charged to in-state 
pharmacies to cover the additional costs associated with 
administrative review and consideration of documents listed in 
subparagraphs a, b and c of paragraph 2 of this section.
SECTION 3.  This act shall become effective November 1, 2013.
54-1-367 JAM 1/25/2013 11:43:36 AM


The pre-filed bill would require non-resident pharmacies to complete an affidavit stating their compliance with USP standards and FDA Good Manufacturing Practices. Additionally, non-resident pharmacies would need to submit current inspection reports from their home state Board of Pharmacy and pay an additional fee for renewal.

While Standridge's bill is a start even if passed it will serve no purpose if there are not more and better inspections and enforcement of the laws and regulations.  Anyone can sign an affidavit stating compliance with USP standards and FDA Good Manuafacturing Practices.  What are the consequences for signing such an affidavit if it is false?  And how does it work when the inspection in another state is based on different standards and laws than those in the state of Oklahoma?  No problem if the other states' standards are higher, or is there?  There is definitely a problem if the other state has  lower inspection standards?  Can you never do business in Oklahoma again if you submit a false affidavit?  The bill provides no fine or consequences for failure to comply with the provisions.  And is $100.00 really enough of an additional fee to charge out of state pharmacies who do business here?   The bill provides for no additional funding at the Oklahoma State Board of Pharmacy. This also is another example of how complex and complicated the patchwork legislation can be for pharmacies to comply with in all states.   This proposed legislation maybe a start in Oklahoma but is by no means a solution to the problems in the compounding world.

As note that Oklahoma State Senator Bingman has written Senate Bill 250, addressing workers compensation program reimbursement whereby compounded medications would be paid by the state's worker's compensation court at the rate of ingredient costs plus a $5.00 dispensing fee. Senate Bill 250 is a companion bill to pre-filed legislation in the Oklahoma House -- HB 1546.




Okla. Senate OKs bill on prescription compounds - NewsOn6.com - Tulsa, OK - News, Weather, Video and Sports - KOTV.com |

Thursday, February 21, 2013

Bill Deadline in California Legislature Promises a Few Insurance Issues By Don Jergler | February 20, 2013


Compounding drugs may be another workers’ comp-related issue that warrants a bill.
A report on compounding drugs released earlier this month reveals the effects of another workers’ comp-related law enacted at the beginning of 2012. Price controls were created via Assembly Bill 378, authored by lawmaker Jose Solorio, D-Santa Ana, to address a rise in the utilization and cost of compounded drugs in workers’ comp.
But while the law, which took effect at the beginning of 2012, may have helped push compounded drug prescriptions down from 3.1 percent in 2011 to 2 percent of California workers’ comp prescriptions in 2012, those compounders seemed to have more than made up for it.
Continue reading here

Saturday, February 16, 2013

Proposed Legislation in California Relating to Nonresident Pharmacies


BILL NUMBER: AB 299 INTRODUCED
 BILL TEXT


INTRODUCED BY   Assembly Member Holden

                        FEBRUARY 12, 2013

   An act to amend Section 4112 of the Business and Professions Code,
relating to pharmacy.


 LEGISLATIVE COUNSEL'S DIGEST


   AB 299, as introduced, Holden. Pharmacy.
   The Pharmacy Law governs the business and practice of pharmacy in
this state. That law provides that any pharmacy located outside this
state that ships, mails, or delivers, in any manner, controlled
substances, dangerous drugs, or dangerous devices into this state is
considered a nonresident pharmacy. The law prohibits a person from
acting as a nonresident pharmacy unless he or she has obtained a
license, and imposes various disclosure and recordkeeping
requirements on nonresident pharmacies. Any person who knowingly
violates these provisions is guilty of a misdemeanor.
   This bill would prohibit a nonresident pharmacy or a pharmacy
located in this state that delivers prescriptions via mail from
entering into, or being a party to, an agreement with a health care
service plan or disability insurer that requires a plan enrollee or
insured to utilize mail order services or that requires a plan
enrollee or insured to opt out of a mail order process. By creating
new crimes, the bill would impose a state-mandated local program.
   The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
   This bill would provide that no reimbursement is required by this
act for a specified reason.
   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  Section 4112 of the Business and Professions Code is
amended to read:
   4112.  (a) Any pharmacy located outside this state that ships,
mails, or delivers, in any manner, controlled substances, dangerous
drugs, or dangerous devices into this state shall be considered a
nonresident pharmacy.
   (b) A person may not act as a nonresident pharmacy unless he or
she has obtained a license from the board. The board may register a
nonresident pharmacy that is organized as a limited liability company
in the state in which it is licensed.
   (c) A nonresident pharmacy shall disclose to the board the
location, names, and titles of (1) its agent for service of process
in this state, (2) all principal corporate officers, if any, (3) all
general partners, if any, and (4) all pharmacists who are dispensing
controlled substances, dangerous drugs, or dangerous devices to
residents of this state. A report containing this information shall
be made on an annual basis and within 30 days after any change of
office, corporate officer, partner, or pharmacist.
   (d) All nonresident pharmacies shall comply with all lawful
directions and requests for information from the regulatory or
licensing agency of the state in which it is licensed as well as with
all requests for information made by the board pursuant to this
section. The nonresident pharmacy shall maintain, at all times, a
valid unexpired license, permit, or registration to conduct the
pharmacy in compliance with the laws of the state in which it is a
resident. As a prerequisite to registering with the board, the
nonresident pharmacy shall submit a copy of the most recent
inspection report resulting from an inspection conducted by the
regulatory or licensing agency of the state in which it is located.
   (e) All nonresident pharmacies shall maintain records of
controlled substances, dangerous drugs, or dangerous devices
dispensed to patients in this state so that the records are readily
retrievable from the records of other drugs dispensed.
   (f) Any pharmacy subject to this section shall, during its regular
hours of operation, but not less than six days per week, and for a
minimum of 40 hours per week, provide a toll-free telephone service
to facilitate communication between patients in this state and a
pharmacist at the pharmacy who has access to the patient's records.
This toll-free telephone number shall be disclosed on a label affixed
to each container of drugs dispensed to patients in this state.
   (g) A nonresident pharmacy shall not permit a pharmacist whose
license has been revoked by the board to manufacture, compound,
furnish, sell, dispense, or initiate the prescription of a dangerous
drug or dangerous device, or to provide any pharmacy-related service,
to a person residing in California. 
   (h) A nonresident pharmacy or a pharmacy located in this state
that delivers prescriptions via mail is prohibited from entering
into, or being a party to, an agreement with a health care service
plan or disability insurer that requires a plan enrollee or insured
to utilize mail order services or that requires a plan enrollee or
insured to opt out of a mail order process.  
   (h) 
    (i)  The board shall adopt regulations that apply the
same requirements or standards for oral consultation to a nonresident
pharmacy that operates pursuant to this section and ships, mails, or
delivers any controlled substances, dangerous drugs, or dangerous
devices to residents of this state, as are applied to an in-state
pharmacy that operates pursuant to Section 4037 when the pharmacy
ships, mails, or delivers any controlled substances, dangerous drugs,
or dangerous devices to residents of this state. The board shall not
adopt any regulations that require face-to-face consultation for a
prescription that is shipped, mailed, or delivered to the patient.
The regulations adopted pursuant to this subdivision shall not result
in any unnecessary delay in patients receiving their medication.

   (i) 
    (   j)  The registration fee shall be the fee
specified in subdivision (a) of Section 4400. 
   (j) 
    (   k)  The registration requirements of this
section shall apply only to a nonresident pharmacy that ships, mails,
or delivers controlled substances, dangerous drugs, and dangerous
devices into this state pursuant to a prescription. 
   (k) 
    (   l)  Nothing in this section shall be
construed to authorize the dispensing of contact lenses by
nonresident pharmacists except as provided by Section 4124.
  SEC. 2.  No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.

Source found here

Idaho Board of Pharmacy Proposed Statute and Rule Changes for 2013


2013 Pending Rules

2013 Pending Statute Changes

Utah Introduces Pharmacy Act Amendments S.B. 78


PHARMACY ACT AMENDMENTS
2 2013 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor: J. Stuart Adams

To view the proposed amendments click here

Wednesday, February 6, 2013

More Proposed Legislation in Oklahoma relating to Pharmacies

Ok Bill #HB2100 permits Board of Pharmacy to suspend PBM's license or impose fines for noncompliance with regs, or unfair business practices and also mandates that PBMs may not require accreditation/licensing of providers other than by the Board or State/federal government.  Click here to review bill


Sunday, January 20, 2013

Legislative Outlook: Compounding, Track and Trace, Animal Drug User Fee Could Carry Human Drug Proposals


ADUFA reauthorization may become the vehicle to move track and trace and compounding legislation. Reimbursement changes to mitigate shortages appear less likely.
Legislative Outlook: Animal Drug User Fee Could Carry Human Drug Proposals
Article preview from "The Pink Sheet"-  January 14, 2013
FDA policy watchers will not have a massive Prescription Drug User Fee Act to track in 2013, which may be good or bad news, but an “-UFA” bill again may steal the spotlight.
As 2012 ended, industry and FDA were digesting the implementation of the FDA Safety and Innovation Act.
Amid that massive task, the new Congress takes office with efforts to reach an agreement on drug shipment tracking standards and enhanced compounding regulations still pending. Additional enhancements to drug shortage mitigation efforts and antibiotic development also are lingering.
It appears the most likely vehicle for any agreements, should they be reached, is the animal drug user fee reauthorization, which must be renewed this year. It could serve as a must-pass bill for members of Congress to insert more FDA policy changes for human drugs.
Compounding and track and trace are both high-profile, but highly complicated, issues with fragmented stakeholder groups making proposals difficult to negotiate. However, the bipartisan interest in track and trace and compounding legislation makes both more likely to maintain their momentum.
Read the rest of this article now by purchasing it as a PDF.

Tuesday, January 8, 2013

Reforming the Board of Pharmacy and Compounding Industry


Governor Patrick has filed legislation to reform the Board of Pharmacy and strengthen state oversight of the compounding pharmacy industry. This legislation, along with related actions the Administration is taking, builds on recommendations released last week by the Commission on Pharmacy Compounding.
“There is no action that we in government can take to prevent all abuses in all industries – but we must do what we can. This legislation makes patient safety paramount and will help fill the gaps in compounding pharmacy monitoring that allowed NECC to operate in the shadows,” said Governor Patrick. “Together these changes can ensure that the tragic events of last fall never happen again.”
Four Key Parts of the Legislation:
  1. Requires a special license for sterile compounding that will help regulators hold pharmacies accountable for their practices.
  2. For the first time, authorizes the Board to assess fines against Massachusetts licensed pharmacies that violate Board of Pharmacy policies, regulations, or statute; and establishes whistleblower protections for pharmacists and pharmacy staff.
  3. Requires licensure for out of state pharmacies that deliver and dispense medications in the Commonwealth.
  4. Establishes a clear process to restructure and reorganize the composition of the Board of Pharmacy. The Board will include more members not practicing in the industry they are responsible for regulating. Under the legislation, the 11 member Board would be comprised of four pharmacists, one nurse, one physician, one pharmacy technician, one quality improvement expert, and three public members.
This announcement comes as the first of several reforms the Governor will propose over the next week to address specific needs as part of the Administration's continuing efforts to make government work better.
Read More:
Source found here

Saturday, January 5, 2013

Copy of Proposed Legislation in Massachusetts

To view click here

Proposed Compounding Bill in Massachuetts Would change Composition of State Pharmacy Board to Include Others Than Pharmacists!!

The recently proposed bill in Massachuetts would change the composition of the state Pharmacy Board, which is dominated by registered pharmacists, and provide for the appointment of a registered nurse, a physician, a pharmacy technician and three public members. It would make board members subject to financial disclosure requirements.

Tuesday, December 25, 2012

Smooth Sailing For FDA



Volume 90 Issue 52 | p. 35
Issue Date: December 24, 2012
Congress made it a top priority this year to pass the FDA Safety & Innovation Act (S. 3187), a bill that reauthorizes FDA to collect fees from the pharmaceutical and medical device industries to help accelerate the review of new drugs and devices. After numerous hearings this year, the bill cleared both the House of Representatives and Senate in June and was then signed into law by President Barack Obama.
The legislation allows FDA to collect user fees from industry for five years, beginning in fiscal 2013. Such fees provide about 60% of FDA’s drug review budget and 20% of its device center budget. The bill also authorizes, for the first time, user-fee programs for generic drugs and biosimilars—the generic equivalents of biologic drugs. In addition, it permanently authorizes two programs aimed at increasing the safety and effectiveness of drugs and medical devices for children.
Concerns of drug shortages and the safety of an increasingly globalized drug supply chain also prompted lawmakers to tack on several regulatory reforms to the FDAuser-fee bill.
Also part of the user-fee law is a provision that criminalizes a host of designer drugs. The law bans virtually all synthetic marijuana compounds, two stimulants sold as bath salts, and nine hallucinogens called 2C substances for the two-carbon bridge that links a benzene ring and an amino group in these compounds.
FDA was on the congressional radar again this fall because of a multistate outbreak of fungal meningitis, linked to a Massachusetts-based compounding pharmacy that produced injectable steroids. Lawmakers questioned whether the agency has sufficient oversight of compounding pharmacies. Such pharmacies typically mix small batches of drugs and are regulated at the state level, whereas large-scale drug manufacturers are regulated by FDA.
Lawmakers believe that the pharmacy responsible for the meningitis outbreak, the New England Compounding Center, was operating as a drug manufacturer under the guise of a compounding pharmacy.
Hearings related to FDA oversight of compounding pharmacies were held in both the Senate and House after news of the outbreak. In addition, last month Rep. Edward J. Markey (D-Mass.) introduced H.R. 6584. The bill would preserve state regulatory authority for small compounding activities and ensure that pharmacies operating as drug manufacturers are regulated by FDA.
Earlier this month, House lawmakers sent a letter to the International Association of Compounding Pharmacies, questioning whether the industry group has a history of encouraging compounding ­pharmacies to impede FDA from evaluating their prod­ucts.

Wednesday, October 24, 2012

What Markey's Planned Federal Legislation Will Include


Lawmaker commends MA Governor, will introduce legislation addressing loopholes in federal oversight of compounding pharmacies
WASHINGTON, D.C. – Congressman Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA), today released the following statement after Massachusetts Governor Deval Patrick and state public health officials announced they are taking steps to address the regulation of compounding pharmacies in the wake of the meningitis outbreak caused by contaminated drugs from the New England Compounding Center (NECC). The state announced the preliminary results of its NECC investigation, which found numerous violations of good sterile compounding practices and other problems, said that it will begin making periodic unannounced inspections of compounding pharmacies that prepare sterile injectable medications; require compounding pharmacies in Massachusetts to submit annual reports of production, volume and distribution of medications; require compounding pharmacies to report to the Board of Pharmacies all interactions with federal regulatory authorities; and form a special commission to examine best practices and advise the state on what changes should make in state law to further assure the public’s safety.

“It is now clear that the New England Compounding Center violated state law and endangered the health of countless patients. I commend Governor Patrick and state and federal officials for their ongoing investigation and for taking immediate and decisive action to update state practices. This is a deadly serious situation involving highly sensitive drugs and vulnerable patients, demanding the strongest response from state and federal authorities and Congress. The longer these compounding pharmacy loopholes are allowed to remain on the books, the longer patients are at risk. That’s why I plan to introduce legislation addressing the regulatory gaps identified by this investigation and strengthening oversight of compounding pharmacies. I look forward to working with my congressional colleagues in a bipartisan manner to move this legislation forward and ensure the safety of patients in the future.”

Rep. Markey plans to introduce legislation that will:
  • Require compounding pharmacies to comply with basic minimum safety standards
  • Ban pharmacies from compounding drugs using ingredients that are not approved by the FDA
  • Require explicit distinction between compounding pharmacies and drug manufacturers
  • Require compounding pharmacies to provide adverse event reports to the FDA
  • Require a warning to patients using any compounded pharmaceutical that it has not been approved safe and effective by the FDA 
From here

Sunday, August 26, 2012

Proposed U.S. legislation would 'set the standard' for global efforts to combat counterfeit drugs

In this Forbes opinion piece, John Lechleiter, president and chief executive officer of Eli Lilly and Company, examines the business of counterfeit medicines, writing, "With global sales last year estimated as high as $200 billion, counterfeit medicine is big business, and it's growing." "In a recent Forbes column, Henry I. Miller cited an estimate by Roger Bate of the American Enterprise Institute that more than 100,000 people die every year from counterfeit drugs," he continues, adding, "That's why fighting counterfeits is essential to safeguarding health. We need action -- national and international -- to better secure the pharmaceutical supply chain." To read remainder of article click here.