More Information on Texas Board of Pharmacy August 6, 2013 Meeting

Board Meeting Agenda Tuesday, August 6, 2013, at 9:00 a.m. The Board business meeting will begin Tuesday, August 6, 2013, at 9:00 a.m.. The  meeting will be held at the William P. Hobby Building, 333 Guadalupe, Tower 2, Room 225, Austin, Texas. Click hereto view the agenda and supporting materials. Rules to be Considered for Adoption Amendments to the following rules were proposed by the Board and published in the June 28, 2013, issue of the Texas Register and will be consider for adoption at the August 6, 2013, Board business meeting. Amendments to §281.6 Concerning Mental or Physical Examination Amendments to §281.22 Concerning Informal Disposition of a Contested Case Amendments to §281.63 Concerning Criminal Offenses Amendments to §281.66 Concerning Reinstatement Amendments to §281.67 Concerning Sanctions for Out-of-State Disciplinary Actions Amendments to §291.34 Concerning Records  TSBP is seeking pharmacists to assist in disciplinary proceedings, including case preparation and presentation for non-therapeutic dispensing and negligent practice cases. To learn more about this opportunity to advance professional care and concern for the practice of pharmacy, contact Caroline Hotchkiss at 512/305-8046.

http://www.fdanews.com/newsletter/article?articleId=157527&issueId=17028

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Traceability, E-Labeling Delayed In Congress

Published: August 1st, 2013 

• Industry News
 
• Serialization

As Congress adjourns this week for its traditional August recess, matters of urgent concern to the pharmaceutical industry—national traceability legislation and proposed electronic labeling—have yet to be resolved.

The timeline for a traceability law slowed somewhat last week in the Senate when the Health, Education, Labor, and Pensions Committee (HELP) called back its proposed bill for amending.

Yet S. 959, The Pharmaceutical Quality and Accountability Act—into which a separate act designed to crack down on pharmacy compounding is folded-- was then “hotlined’ this week in the Senate. Hot lining is process in which members are requested to allow a bill to be approved by the Senate without debate or amendment.

“Senate leadership is in the process of determining what amendments, opposition, or other issues exist at this point. It appears highly unlikely that the bill will be on the floor this week, due to unresolved issues related to compounding, so we are looking at September for floor activity at the earliest,” said one supply chain source.

The Senate and House will have to reconcile two bills with considerable differences when Congress comes back into session next month.

The latest HELP committee amendments include one notable change: manufacturers four years after enactment are required to provide transaction information in electronic form, Dirk Rodgers reports in his RxTrace blog.

The HELP bill has required manufacturers to affix the standard numerial identifier (SNI) to unit level packaging four years after enactment, with supply chain deployment of interoperable electronic tracing of product at the package level after ten years.

The Pharmaceutical Distribution Security Alliance, the supply chain coalition lobbying for preemptive federal legislation, has expressed confidence the committees can narrow their differences in short order.

“PDSA is optimistic the bill will make its way to the President’s desk in September. We have no sense of opposition in the Senate and see differences between the two bills as being highly bridgeable,” PDSA said in a statement this week.

Yet supporters of the Senate’s approach –which clearly mandates unit level traceability—are opposing the House bill—endorsed by the full House of Representatives in May—as far too weak.

The Senate bill establishes a unit level traceability system in ten years through self-effecting statute, meaning FDA would not have to create new regulations to implement it, says Allan Coukell, senior director of drugs and medical devices, The Pew Charitable Trusts.

The House bill directs FDA to create proposed regulations on an enhanced system no earlier than 2027, with no requirement for a final rule, Coukell says.

“The main difference between the Senate and House bills is certainty and timing. The Senate provides certainty that a unit level system will be established in ten years. The House requires only proposed regulations no earlier than 2027,” Coukell says.

While the Senate bill combines two bills on traceability and compounding, the House bill includes a provision on electronic labeling absent in the Senate bill. The measure that would allow manufacturers to provide the professional package insert exclusively in electronic form is being opposed by the Pharmaceutical Printed Literature Association.

PPLA last week praised a report issued by the Government Accountability Office on drug e-labeling that it says validates industry concerns: e-labeling will impact patient safety, and largely destroy the specialty printing industry.

As with the anxiously anticipated track and trace legislation, industry will have to wait a while longer to see the outcome of the House’s push for e-labeling.

 continue to read here

Has Bid to Hotline Compounding Bill Been Shelved for Now? See Medicines track-and-trace bill delayed until after August recess ; Phil Taylor 02-Aug-2013

An updated version of a bill that aims to introduce a federal traceability system for medicines and new rules for compounding pharmacies in the US has been published.

There had been hopes that the Pharmaceutical Quality, Security and Accountability Act (S. 959) might make it to the Senate floor in July, but the time taken to incorporate amendments by the Health, Education, Labor, and Pensions Committee (HELP) committee means it will now be considered no earlier than September.

The PQSA would create a lot-level traceability system that within 10 years of adoption would be upgraded to full unit-level traceability of medicines based on the application of standard numerical identifiers (SNIs) to unit level packaging (see Senators clear medicine-tracking bill for floor debate).

Most of the amendments to the track-and-trace elements are relatively minor, according to summary documents provided by the HELP committee, although there are new provisions such as requiring transaction records be kept in electronic form only four years after enactment when manufactures are required to serialise product.

The amendments to the compounding section of the PQSA are more involved, including for example a provision to allow the US Food and Drug Administration (FDA) to draw up lists of drugs that are complex and should not be compounded at all, as well as bulk ingredients that must not be used in compounded products.

It also clarifies that traditional pharmacies - rather than the new category of "compounding manufacturers" that make sterile products without, or in advance of, a prescription and sell those products across state lines - may continue to compound a drug for a doctor to use in the office and would be overseen by state authorities.

What remains unclear is the path of the proposed legislation from now on. SecuringIndustry.com understands the amendments do not have to return to the HELP committee for approval. Meanwhile, there have been suggestions that it could pass the Senate promptly as a request has been made it have the bill "hotlined" - a measure used to pass non-controversial legislation without a formal vote.

In order for a bill to be hotlined, the Senate Majority Leader and Minority Leader must agree to pass it by unanimous consent, without a roll-call vote, and - if no objections are registered - it is automatically passed.

With stakeholders lobbying against the bill - particularly from the compounding pharmacy sector - there is every possibility that objections may be raised to block the hotlining process.

[Ed. As this article went to press there were reports that the bid to hotline the bill had been shelved, but we have so far been unable to verify this.]

Even if S.959 is passed, Congress will still have to reconcile it with a House of Representatives bill (HR. 1919), which passed the House by a voice vote on June 3 (see House drug traceability bill makes stride forward) but had been criticised for setting a long timeframe before unit-level track-and-trace is required.

For the moment at least though it seems like some form of federal track-and-trace system that could avoid an unharmonised patchwork of state-level requirements is closer than ever before.

quoted from here

August 1, 2013 Meningitis outbreak: Local suit transferred to Boston-Ameridose

A lawsuit filed by a Kentucky couple against Saint Thomas OutpatientNeurosurgery Center has been transferred from federal court in Nashville to U.S. District Court in Boston, where it will be merged into other suits stemming from a fatal outbreak of fungal meningitis.

According to the suit, Carolyn Bland of Cadiz, Ky., was injected with a fungus-tainted spinal steroid on Sept. 9, 2012. The suit names as defendants the owners of the New England Compounding Center and several related firms, including another drug company, Ameridose LLC, and a real estate firm. Bland’s husband, Leon, is also a plaintiff.

Dozens of similar suits, including several filed by Tennessee victims and their families, have already been merged before U.S. District Judge F. Dennis Saylor IV in Massachusetts.

Contact Walter F. Roche Jr. at wroche@tennessean.com or 615-259-8086.

quoted from here

University of Michigan College of Pharmacy Presents CEU Including The Changing Landscape of Pharmacy Compounding David Brushwood, RPh, JD Professor of Pharmaceutical Outcomes & Policy The University of Florida College of Pharmacy Gainesville, Florida

Annual Pharmacy Lectures
Program Schedule

Date: Friday, October 4, 2013

Location: Weber's Inn, 3050 Jackson Ave., Ann Arbor, MI 48103

Time: 8:15 AM to 4:30 PM

Cost: $95 / person

7:45 am              Registration and continental breakfast (included in registration fee)

8:15 am              Welcome and program introduction

8:30 am              Morning lectures

Managing the Fungal Outbreak: Pharmacists' View from the Front Lines

Robert Loveland, BSPharm, PharmD

Outpatient Pharmacy Manager

St. Joseph Mercy Hospital

Ann Arbor, Michigan

Nina E. West, PharmD

Clinical Pharmacy Manager

St. Joseph Mercy Hospital

Ann Arbor, Michigan

Kimberlyn M. Dang, PharmD

Generalist Pharmacist

University of Michigan Health System

American Health Hospital Letter to Senator Harkin August 1, 2013

[PDF]

August 1, 2013 The Honorable Tom Harkin United States Senator ...

www.aha.org/advocacy-issues/letter/.../130801-let-pollack-harkin.pdf?...‎

11 hours ago - Having safe compounded medications available is essential for patient care in ... gaps in regulatory oversight of organizations that engage in compounding.

House hearing considers compounding proposals August 01, 2013 Draft would not give FDA new authorities; FDA, pharmacy, and other groups testify

The Republican-controlled House Energy & Commerce Subcommittee on Health on July 16 held a hearing to examine three compounding legislative proposals, namely the Senate Health, Education, Labor, & Pensions (HELP) Committee bill (S. 959), a bill introduced by former House Democrat Sen. Ed Markey (D-MA) (H.R. 2186), and a discussion draft put forward by Rep. Morgan Griffith (R-VA). Unlike the two bills sponsored by Democrats, Griffith’s draft proposal contained no new authorities for FDA.

“We are not trying to take anything away from the current FDA authority,” Griffith said deep into the nearly 3-hour hearing. “We are trying to clarify without going too far.”

Materials for the hearing, Reforming the Drug Compounding Regulatory Framework, were posted on the House Energy & Commerce website. These materials include S. 959, H.R. 2186, Griffith’s discussion draft, and written testimony from the witnesses’ organizations, including FDA on the first panel and the National Community Pharmacists Association (NCPA), American Society of Health-System Pharmacists (ASHP),Pharmaceutical Research and Manufacturers of America, Generic Pharmaceutical Association, Pew Charitable Trust, International Academy of Compounding Pharmacists (IACP), and National Association of Boards of Pharmacy (NABP) on the second panel.

At issue in the drive by Congress to address the regulatory gray area occupied by the evolving compounding industry is section 503A of the Federal Food, Drug, and Cosmetic Act, which was added to the law in 1997. Section 503A exempts compounded drugs from three of the law’s provisions, including the premarket approval for new drugs, the requirement that a drug be made in compliance with current Good Manufacturing Practice (cGMP) standards, and the requirement that the drug bear adequate directions for use, provided certain conditions are met, according to FDA’s written testimony. Subsequent court decisions have “amplified the perceived limitations and ambiguity associated with FDA’s enforcement authority over compounding pharmacies.”

Griffith draft made public

Griffith’s discussion draft would amend section 503A to clarify that the following conditions in general must be met: identified patient and receipt of prescription; timing and specificity of prescription or purchase order, including submission of a patient-specific valid prescription order to the pharmacist or physician not later than 7 days after the drug product is administered; compounding in compliance with U.S. Pharmacopeia standards; compounding using bulk drug substances and other ingredients in compliance with applicable monographs, with exceptions; drug products that do not appear on a “do not compound” list; drug products that are not essentially a copy of a commercially available drug product; drug products not presenting demonstrable difficulties for compounding; and a volume limitation yet to be determined.

Griffith’s bill also would require a system for improved communication between FDA and state boards of pharmacy related to actions taken about compounding pharmacies or concerns that a compounding pharmacy may be acting illegally as a manufacturer, developed in consultation with NABP; FDA to review submissions from state boards of pharmacy and follow up with inspections of pharmacies in violation of the law not later than 60 days after receiving a submission; an advisory committee on compounding including representatives from NABP, the U.S. Pharmacopeia, pharmacy organizations, physician organizations, consumer organizations, and others; updating lists at least once a year; and a review of FDA regulations on the possibility of adverse event reporting by compounding pharmacies.

Seeking feedback from FDA

At the beginning of the hearing, Griffith indicated that he wanted to draw a line between compounders and manufacturers with respective state and FDA oversight. He pressed the first witness, FDA’s Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research, for a number to nail down at what volume a compounding pharmacy can be classified as a manufacturer. “We’re never going to get it perfect. But let’s get it 80 to 90 yards down the field.”

Griffith also pressed for a number on the shelf life of compounded drugs. “I know this is difficult,” he added. “But sometimes we have to pull the trigger and figure out what the numbers are.”

Then Rep. Henry Waxman (D-CA) supported FDA’s repeated arguments for new authorities over a new class of nontraditional compounders that doesn’t fit neatly within the “binary structure” of compounders and manufacturers under current law. He said that the agency needed strong records inspection authority, compounders to register, reporting of adverse events, and “a steady stream of resources.”

But Health Subcommittee Vice Chairman and Rep. Michael C. Burgess, MD, (R-TX) called new authorities for FDA a “power grab” and asked who at FDA had been fired over the deadly fungal meningitis outbreak linked to the now-closed New England Compounding Center (NECC). “It doesn’t sound like a gap in the statute,” he said. “It sounds like an enforcement issue.”

Woodcock responded to a question from Waxman about the 7-day provision in Griffith’s discussion draft that FDA was “struggling to put some type of quantitative framework.” Woodcock told Rep. John D. Dingell (D-MI) that FDA proposed using interstate commerce as a proxy for risk. In a later exchange with Rep. Marsha Blackburn (R-TN) related to the volume limitation, Woodcock told her, “We have struggled with this and we have had a very difficult time coming up with a coherent scheme that would use volume.”

Rep. Kathy Castor (D-FL) asked Woodcock to weigh in on the three legislative proposals on the table. Woodcock preferred the Senate bill and said, “We feel that’s a good start.”

Pharmacy groups diverge

Soon the rest of the witnesses had their chance to provide summaries of their written statements, followed by questioning from Members of Congress. Among the witnesses were representatives of pharmacy organizations.

NCPA CEO B. Douglas Hoey, BSPharm, MBA, supported Griffith’s discussion draft as striking the “proper balance.” NCPA specifically supported its preservation of state board of pharmacy oversight of pharmacy compounding and preservation of office use and anticipatory compounding.

ASHP’s Kasey K. Thompson, PharmD, MS, Vice President of Policy, Planning, and Communications, said that the evolution of the compounding outsourcing industry has outpaced the law’s ability to keep up. He expressed concern that state boards of pharmacy may not have the capability to determine whether compounders have crossed the line into manufacturing. ASHP believed that FDA should regulate compounding outsourcers.

IACP Executive Vice President and CEO David G. Miller, BSPharm, said that Griffith’s discussion draft was “the closest solution.” He said that NECC “fundamentally has uncovered a real gap in our laws” and noted that during the day’s testimony he had heard “six different terms to define this thing that we are attempting to regulate.”

NABP Executive Director Carmen Catizone, MS, BSPharm, DPh, said that NABP supported the Senate HELP bill and the new category of compounding manufacturing falling under the purview of the FDA. “There are provisions in the House bills that could take us in the wrong direction and could lead to another NECC tragedy,” he said.

During the question-and-answer part of the hearing for the second panel, Griffith said, “I don’t believe that our bill would have allowed the NECC situation to have occurred.” As the second panel’s witnesses suggested ways to clarify section 503A—volume, expiration dates, interstate commerce, percentage of business—Griffith added, “We’re going to have to draw the line somewhere.”

QUOTED FROM Diana Yap
Senior Assistant Editor, Pharmacy Today

Question of the Day August 2, 2013 Why Hasn't the FDA Taken Any Enforcement Action Against Compounders Who Are Making Commerically Available Products?

August 2, 2013 List of Products Recalled from Beacon Hill Medical Pharmacy

Beacon Hill Pharmacy d/b/a Rxtra Solutions Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance

Contact:
Consumer:
Dr. Wissam Alawieh, Pharm.D.
(800) 518-9831
 

FOR IMMEDIATE RELEASE - July 31, 2013 – Southfield, MI, Beacon Hill Medical Pharmacy d/b/a/ Rxtra Solutions (Beacon Hill) is voluntarily recalling all lots of certain sterile products to the user level. There is a question of sterility assurance for the affected products raised by the FDA.

Microbial contamination of products intended to be sterile can lead to serious infections, which may be life-threatening. Beacon Hill has not received any reports of adverse events related to this recall and to date, there is no evidence of contamination in the recalled products or any previously prepared products.

Below is the list of sterile injectable products compounded by Beacon Hill/Rxtra Solutions prescribed by physicians to individual patients according to their prescription order in alphabetical order, organized by Drug name and strength:

ACETYLCYSTEINE 100 MG/ML INJ SOLN	APOMORPHINE HCL 3 MG/ML INJECTABLE	ASCORBIC ACID ( CORN SOURCE) 500 MG/ML INJECTABLE
ASCORBIC ACID (NON CORN SOURCE) 500 MG/ML INJECTABLE	B-12 REJUV 25 MG/ML INJECTABLE	B-12/LIDOCAINE 25/10MG/ML INJECTABLE
B-COMPLEX/LIDO/B-12 25MG/ML INJECTABLE	B-COMPLEX/LIDOCAINE 2% INJECTION INJECTABLE	BI-TROPIN S-2 INJECTABLE
BUPRENORPHINE 0.3 MG/ML INJECTABLE	BUPRENORPHINE 0.5 MG/ML INJECTABLE	CALCIUM CHLORIDE 100 MG/ML
CALCIUM EDTA 200 MG/ML INJECTABLE	CALCIUM EDTA 300 MG/ML INJECTABLE	CHROMIUM 4 MCG/ML INJECTABLE
COPPER 0.4MG/ML INJECTABLE	CYANOCOBALAMIN 1000 MCG/ML INJ SOLN	CYCLOSPORIN (A) 2% (PF) AQUEOUS SUSP
DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTABLE	DEXPANTHENOL 250 MG/ML INJECTABLE	DEXTROSE PF 50% INJECTABLE
DIAZEPAM 5MG/ML INJECTABLE	DMPS P/F 50 MG/ML INJECTABLE	DMSO 50% INJ 50 ML VIAL INJECTABLE
DUAL-TESTOSTERONE 10ML VIAL(COTTON SEED OIL) 200 MG/ML OIL INJ SOLN	DUAL-TESTOSTERONE 2 ML VIAL 20 MG/ML OIL INJ SOLN	DUAL-TESTOSTERONE 4 ML VIAL 50 MG/ML OIL INJ SOLN
DUAL-TESTOSTERONE 5 ML VIAL 50 MG/ML OIL INJ SOLN	EDETATE DISODIUM 150 MG/ML INJECTABLE	ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 MG/ML OIL INJ SOLN
OXYTOCIN 10 UNITS/ML INJECTABLE	ESTRIOL 5 MG/ML OIL INJ SOLN	AMINO ACID III (COMPARE TO FREAMINE III) ALT. 8.5% INJECTABLE
ARGININE 100MG/ML INJECTABLE
FUROSEMIDE 10MG/ML INJECTABLE	GLUTATHIONE 200 MG/ML (PF) INJ SOLN	GLUTATHIONE/LIDO 100MG/2%/ML (PF) INJ SOLN
GLUTATHIONE/METHYL/LIDO 1 00/25/20 MG/ML INJ SOLN	GLUTATHIONE/METHYL/LIDO 100/25/20MG/ML (PF) INJ SOLN	GLYCINE 50 MG/ML INJECTABLE
GLYCYRRHIZIC ACID 8 MG/ML INJECTABLE	HYALURONIDASE 150U/ML INJECTABLE	HYALURONIDASE 200U/ML INJECTABLE
HYDROXOCOBALAMIN (VITAMIN B12A) 1 MG/ML INJECTABLE	L-CARNITINE HCL 50 MG/ML INJECTABLE	LIDOCAINE MDV 1% INJECTABLE
LIDOCAINE MDV 20 MG/ML INJECTABLE	LIDOCAINE PF 20 MG/ML INJECTABLE	LIPOIC ACID 100 MG/ML INJECTABLE
LIPOIC ACID 200 MG/ML INJECTABLE	LIPO-PLEX INJECTABLE	LIPO-PLEX/LIDOCAINE 2% INECTABLE INJECTABLE
L-TRYPTOPHAN 300 MG/ML INJECTABLE	MAGNESIUM CHLORIDE HEXAHYDRATE 20% INJECTABLE	MAGNESIUM SULFATE 50% INJECTABLE
MANGANESE SULFATE 0.1 MG/ML INJECTABLE	MELOXICAM 10 MG/ML INJECTABLE	MELOXICAM 5MG/ML INJECTABLE
METHYLCOBALAMIN (PF) 1 MG/ML INJ SOLN	METHYLCOBALAMIN (PF) 25 MG/ML INJECTABLE	METHYLCOBALAMIN 1 MG/ML INJ SOLN
METHYLCOBALAMIN 10 MG/ML INJ SOLN	METHYLCOBALAMIN 25 MG/ML INJECTABLE	METHYLCOBALAMIN 5 MG/ML INJ SOLN
METHYLPREDNISOLONE ACETATE 40 MG/ML INJECTABLE	METHYLPREDNISOLONE ACETATE 80 MG/ML INJECTABLE	MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0.1MG/ML INJECTABLE
MIC-CARN MAX (WITH METHYLCOBALAMIN) 15/100/50/1 MG/ML INJECTABLE	MIC-CARN MAX 15/100/50/1 MG/ML INJECTABLE	MIC-CARN MAX PLUS LIDOCAINE 15/100/50/1 MG/5MG/ML INJECTABLE
PHOSPHATIDYLCHOLINE 50 MG/ML INJECTABLE	POTASSIUM CHLORIDE 2 MEQ/ML INJECTABLE	PROCAINE P/F 20 MG/ML INJECTABLE
PROG/TEST CYP 15/7.5 MG/ML OIL INJ SOLN	PROGESTERONE 50 MG/ML OIL INJ SOLN	PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP
PYRIDOXINE HCL P/F 100 MG/ML INJECTABLE	QUAD AMINO BLEND 150/75/150/75 MG/ML INJECTABLE	SELENIUM 400 MCG/ML INJECTABLE
SERMORELIN ACETATE 10 MG INJECTABLE	SERMORELIN ACETATE 3 MG INJECTABLE	SODIUM BICARBONATE PF 8.4% INJECTABLE
TACROLIMUS SOLUTION 0.02% OPHTHALMIC	TEST. HYPOALLRGNC 200 MG/ML INJECTABLE	TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE
TESTOSTERONE CYPIONATE 10 ML VIAL 100 MG/ML OIL INJ SOLN	TESTOSTERONE CYPIONATE 2 ML VIAL 20 MG/ML INJECTABLE	TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP
TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN	TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN	TRIPLE-TESTOSTERONE 10 ML VIAL 250 MG/ML OIL INJ SOLN
TRIPLE-TESTOSTERONE 5 ML VIAL 200 MG/ML OIL INJ SOLN	TRIPTROPIN PLUS INJECTABLE	VITAMIN B- COMPLEX INJECTABLE
VITAMIN B-COMPLEX SL SOLTN	VITAMIN B-COMPLEX (PF) INJECTABLE	VITAMIN D 50,000 I.U./ML INJECTABLE
ESTRADIOL CYPIONATE 10 MG/ML OIL INJ SOLN	ESTRADIOL CYPIONATE 40 MG/ML OIL INJ SOLN	ESTRADIOL CYPIONATE 5 MG/ML OIL INJ SOLN
TRACE ELEMENTS-5 INJECTABLE	NALBUPHINE HCL 20MG/ML INJECTABLE	NANDROLONE DECANOATE 200 MG/ML OIL INJ SOLN
NANDROLONE DECANOATE 100 MG/ML OIL INJ SOLN	ALPROSTADIL 100 MCG/ML INJ SOLN	NALTREXONE 1 MG/ML INJECTABLE
NALTREXONE 200 MG/ML INJECTABLE	HYDROCHLORIC ACID 10% INJ SOLN
ZINC SULFATE 1 MG/ML INJECTABLE	ALPROSTADIL 50 MCG/ML INJ SOLN	AMMONIUM MOLYBDATE 25 MCG/ML INJECTABLE
B12/E2/E3/PROG/TEST 1/3.75/2.5/50/45 MG/ML OIL INJ SOLUTION	BI-MIX PHENTOLAMINE/PAPAVERINE 0.5 MG/30 MG/ML INJECTABLE	BI-MIX PHENTOLAMINE/PAPAVERIN E 1 MG/30 MG/ML INJECTABLE
BUPRENORPHINE 0.1/0.05 MG/ML CREAM	DUAL-TESTOSTERONE 100 MG/ML OIL INJ SOLUTION	DUAL-TESTOSTERONE 150 MG/ML OIL INJ SOLUTION
DUAL-TESTOSTERONE 200 MG/ML OIL INJ SOLUTION	DUAL-TESTOSTERONE 50 MG/ML OIL INJ SOLUTION	ESTRADIOL VALERATE W/LIDOCAINE 1% 40MG/ML OIL INJ SOLN
GLUTAMINE 100 MG/ML INJ SOLN	H.C.G. (COMPOUNDED) 10,000 UNIT VIAL INJECTABLE	H.C.G. (COMPOUNDED) 11,000 UNIT VIAL INJECTABLE
H.C.G. (COMPOUNDED) 12,000 UNIT VIAL INJECTABLE	H.C.G. (COMPOUNDED) 5,000 UNIT VIAL INJECTABLE	H.C.G. (COMPOUNDED) 8,000 UNIT VIAL INJECTABLE
HYDROGEN PEROXIDE 3% INJECTABLE	HYDROCYPROGESTERONE CAPROATE 250 MG/ML OIL INJ SOLN	KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE
PARABEN WATER FOR INJECTION	SODIUM HYDROXIDE 10% (W/V) WATER FOR INJECTION	SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%
SODIUM PHOPHATE MONOBASIC/WATER FOR INJECTION 10%	TESTOSTERONE CYPIONATE (COTTONSEED) 200 MG/ML OIL INJ SOLN	TESTOSTERONE PROPRIONATE 100 MG/ML OIL INJ SOLN

Physicians prescribe these products to patients receiving IV solutions and hormone replacement therapy.

These products are packaged in clear or amber sterile injectable vials ranging in size of 1 ml to 100 ml containing liquid solution, suspension or lyophilized powder. The products are packaged in either individual patient prescription vials or single units in a cardboard box container. The products can be identified via the label format, which will include lot numbers initiating with code 01012013@1 to 07262013@99. The vials will contain a label indicating the drug name, strength, and quantity of product in the vial, the lot number with the codes indicated above, and a recommended use by date, product ingredients, storage instructions and the facility information and address. A sample vial label and prescription label is attached that includes the exact format for all products dispensed. The products were distributed nationwide to outlets including hospitals, clinics, and patients who have received orders by directly placing phone calls or faxed prescriptions to the Beacon Hill Medical pharmacy facility in Southfield, Michigan.

Beacon Hill began notifying its customers on July 26th 2013 via telephone, and will begin initiating recall mailers including formal letters, and will continue to call its patients and providers, and schedule office visits to discuss with physicians further. Beacon Hill is arranging for return of all recalled products. Health care providers, hospital staff and patients should immediately check their inventory, identify products in their possession, which are being recalled, stop utilizing product and contact Beacon Hill Medical Pharmacy at 800.518.9831 to further assist with product replacement, continuity of care and further instructions on product return.

Beacon Hill recognizes FDA's observations of sterile practices and 211 guidelines and has already initiated its facility upgrade in an effort to deliver at the highest manufacturing standard. Beacon Hill has initiated testing on products in the recall in quarantine in an effort to assess its validation process of prior sterility practices and will continue to cooperate with the FDA to establish 211guided standards of practice.

Beacon Hill is dedicated to this voluntary recall and has set up a task force of pharmacists and personnel ready to establish a transition for product replacement and urges patients to contact the pharmacy for any assistance.

Consumers with questions regarding this recall can contact Beacon Hill by calling 800.518.9831 during the business hours of 10 am and 6 pm eastern standard time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
  www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

August 2, 2013 ANOTHER COMPOUNDING RECALL--Michigan Compounding Pharmacy-Beacon Hill Medical Pharmacy-- Issues Recall Over Sterility Concerns

By Kelly Young

Beacon Hill Medical Pharmacy in Michigan has issued a nationwide recall of all lots of 135 different IV solutions and hormone replacement therapies because it cannot guarantee their sterility, according to a company announcement distributed by the FDA.

The company is unaware of any adverse events associated with the products, and there is no evidence of contamination.

The clear or amber vials are filled with 1 mL to 100 mL of liquid solution, suspension, or lyophilized powder. Physicians, hospitals, and patients are instructed to check their inventories and return the affected lots to the manufacturer.

The manufacturer's recall notice provides a list of the products.

LINK(S):

Manufacturer's recall notice (Free)

- See more at: http://www.jwatch.org/fw107765/2013/08/02/michigan-compounding-pharmacy-issues-recall-over#sthash.8Ln5CLBR.dpuf

Safety Alerts for Human Medical Products Beacon Hill Medical Pharmacy/Rxtra Solutions: Recall - Lack of Sterility Assurance

Safety Alerts for Human Medical Products Beacon Hill Medical Pharmacy/Rxtra Solutions: Recall - Lack of Sterility Assurance

Bring drug compounding firms out of the shadows Article by: EDITORIAL BOARD , Star Tribune Updated: August 1, 2013 - 7:00 PM Pass ‘compounding’ reforms before another outbreak kills.

The headlines generated last fall by a meningitis outbreak linked to injectable drugs manufactured in filthy conditions may have faded. But Congress is sorely mistaken if members believe that the outrage over this massive pharmaceutical public health disaster and regulatory failure — 749 people were infected, 61 died — has ebbed.

Firms like the New England Compounding Center, which shipped more than 17,000 potentially contaminated vials to more than 20 states, including Minnesota, should not be operating in the regulatory shadows by exploiting the legal leeway traditionally given to Main Street pharmacists to mix (or “compound”) custom medications for clients. Instead, big compounding firms like NECC, whose dirt- and debris-filled facilities shocked investigators and the public, should clearly be subject to federal oversight like other drug manufacturers so that future outbreaks and deaths can be prevented.

Congress has had nearly a year to take common sense steps to address the regulatory gray zone between state authority over pharmacies and federal authority over big, traditional drug manufacturers. These blurred lines sometimes allow the relatively smaller-scale compounding industry to escape sufficient oversight or legally challenge the U.S. Food and Drug Administration’s attempts to regulate it, even as firms ship voluminous amounts of products across state lines.

While pragmatic, thoughtful reforms have been proposed by a bipartisan group of senators that includes Minnesota’s Al Franken, Congress has inexcusably failed to enact any measures to improve patient safety.

This week, a critical opportunity to pass the Senate legislation, which is supported by many respected public health organizations, slipped by. Lawmakers had a crowded docket to get through before the summer recess, and the Senate bill failed to progress. The legislation would give the FDA clear authority over large compounding pharmacies that produce sterile products (such as injectable medications) in advance of a prescription and ship it across state lines.

“This bill recognizes that the industry has changed significantly over the last several decades and attempts to mitigate the risks associated with large-scale production of sterile products … This addresses certain high-risk facilities while leaving traditional pharmacy dispensing essentially untouched,’’ wrote Allan Coukell, the senior director for drugs and medical devices for the Pew Charitable Trusts, in a July 29 letter to Senate leaders.

Another likely and troubling reason for the delayed action on the Senate bill: Some high-profile pharmacy industry advocates such as the National Community Pharmacists Association are trying to delay or weaken it. Action alert letters sent out recently described an FDA power grab and claimed the agency already has the authority it needs to regulate the industry.

On Wednesday, a report released by the nonpartisan Government Accountability Office suggested that these criticisms are off base. The GAO report stated unequivocally that FDA oversight does need to be clarified and recommends that Congress consider doing so. It stated that “gaps in oversight of drug compounding” have occurred as a result of the ongoing questions and disputes about the FDA’s authority.

Lawmakers returning this fall will have another opportunity to take up the Pharmaceutical Quality, Security and Accountability Act, and they should move quickly to make this important safety reform a reality. In the meantime, work should continue on the reforms during this long recess to reconcile the Senate measures with those offered in the House.

The Senate bill contains another critical reform that would enhance officials’ ability to track drugs as they move the supply chain — dramatically improving the detection and prevention of counterfeit drugs.

The respected Minnesota Board of Pharmacy endorsed the Senate legislation at its June meeting. These sensible and overdue drug safety reforms merit strong support from Minnesota citizens and its congressional delegation as well.

quoted from here

IACP Town Hall on Wednesday, August 7, 2013, 2 pm EST. David Miller and Sarah Dodge will provide S. 959 update, and share IACP CAMP!

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Texas prison system running out of execution drug By MICHAEL GRACZYK, Associated Press | August 1, 2013 | Updated: August 1, 2013 1:33pm

HUNTSVILLE, Texas (AP) — The nation's most active death penalty state is running out of its execution drug.

The Texas Department of Criminal Justice said Thursday that its remaining supply of pentobarbital expires in September and that no alternatives have been found. It wasn't immediately clear whether two executions scheduled for next month would be delayed. The state has already executed 11 death-row inmates this year, and at least seven more have execution dates in coming months.

"We will be unable to use our current supply of pentobarbital after it expires," agency spokesman Jason Clarksaid. "We are exploring all options at this time."

Texas switched to the lethal, single-dose sedative last year after one of the drugs used in its three-drug execution process became difficult to obtain and the state's supply expired. Other death-penalty states have encountered similar problems after some drug suppliers barred the drugs' use for executions or have refused, under pressure from death-penalty opponents, to sell or manufacture drugs for use in executions.

No executions in Texas were delayed because of that shortfall. But because the shortage is now affecting such an aggressive death-penalty state, the effects could move beyond Texas.

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Louisiana Board of Pharmacy Board Meeting Agenda for August 14, 2013

NOTICE IS HEREBY GIVEN that a meeting of the Board has been ordered and called for 10:00
a.m. on Wednesday, August 14, 2013 at the Board office, for the purpose to wit:
A G E N D A
NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official.
Revised 07-31-2013
1. Call to Order
2. Invocation & Pledge of Allegiance
3. Quorum Call
4. Call for Additional Agenda Items
5. Consideration of Minutes
6. Report on Action Items
7. Confirmation of Acts
8. Opportunity for Public Comment
9. Committee Reports
A.  Finance – Mr. Russell Champagne, CPA & Mr. Pitre  
• Consideration of Final Report for Fiscal Year 2012-2013
• Consideration of Budget Amendment No. 1 for Fiscal Year 2013-2014
B. Application Review – Ms. Melancon
• Consideration of Committee Recommendations re Applications
C. Reciprocity – Ms. Hall
• Consideration of Committee Recommendations re Applications
D. Violations – Mr. Bond
• Consideration of Proposed Voluntary Consent Agreements
E.  Impairment – Mr. Rabb
• Consideration of Committee Recommendations re Applications
F.  Reinstatement – Ms. Melancon
• Consideration of Committee Recommendations re Applications
G. Tripartite – Mr. Burch
H. Regulation Revision – Mr. McKay
• Consideration of Comments from May 30 Public Hearing
I. Executive – Mr. Aron
• Consideration of Committee Recommendations re Policies & Procedures
10. Staff Reports
J. Prescription Monitoring Program – Mr. Fontenot
K. General Counsel – Mr. Finalet
L. Executive Director – Mr. Broussard
• Consideration of Annual Report
• Consideration of Louisiana Compliance Questionnaire
• Consideration of Colleges & Schools of Pharmacy
11. Request for Opinion: Addition of Medications by Non-Pharmacy Practitioners to Parenteral Preparations Previously Compounded by Pharmacies (BioScrip®)
12. Announcements
13. Recess

Louisiana Board of Pharmacy Meetings in August 2013

08-15-2013     Administrative Hearing

08-14-2013     Board Meeting

08-14-2013     Reciprocity Committee

08-13-2013     Executive Committee

08-13-2013     Impairment Committee

08-13-2013     Reinstatement Committee

08-13-2013     Finance Committee

National Association of Pharmacy Boards June/July 2013 Newsletter Has Lots of Compounding Information

It can be read here

Question of the Day August 1, 2013 What if another outbreak similiar to NECC or large numbers of animals die such as in Franck's occurs before Congress and/or states are able to pass legislation? Who should then be held criminal and civilly liable? Who should be accountable?

Compounding Legislation’s Rationale Gets Boost From GAO – But Its Details Don’t

By Cathy Dombrowski / Email the Author / Jul. 31, 2013 
Word Count: 903 / Article # 14130731005 / Posted: July 31 2013 8:00 PM

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Executive Summary

A report from the federal watchdog agency backs up FDA’s quest for legislative action, but makes no specific recommendations on how to improve the agency’s capabilities to regulate compounding pharmacies.

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Follow protocols when using medications from compounding pharmacies

Follow protocols when using medications from compounding pharmacies

Study: Compounding pharmacy oversight inconsistent

BOSTON (AP) — A new federal report has concluded that the authority to regulate pharmacies engaged in drug compounding is ‘‘unclear’’ and ‘‘inconsistent’’ at the state and federal levels.

The Government Accountability Office also found that federal circuit court decisions have given the Food and Drug Administration different oversight authority in different parts of the country.

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