NABP Testifies at US House Subcommittee Hearing Regarding Support for Federal Legislation to Distinguish Between Compounding and Manufacturing

NABP expressed its support for federal legislation that would distinguish between compounding and manufacturing, in testimony (PDF) presented at a United States House subcommittee hearing on May 23, 2013. The hearing, “Examining Drug Compounding” was held to provide US Committee on Energy and Commerce Health Subcommittee members an opportunity to hear testimony from Food and Drug Administration (FDA) and health care experts regarding the importance of drug compounding to patients and the current regulation of compounding on the federal and state levels. In its testimony, NABP noted that the clarifications in the proposed Pharmaceutical Compounding Quality and Accountability Act (S 959) regarding the distinction between compounding and manufacturing “provide a safe and equitable environment for both compounding and manufacturing to occur in the best interest of the patient.” The Association stressed that the distinction between compounding and manufacturing is “critical to maintain the present authority of the states and address one of the contributing factors to the NECC [New England Compounding Center] crisis, specifically, the ambiguous authority between the states and FDA.”  The proposed legislation also specifies that a “compounding manufacturer” cannot be licensed as a pharmacy, and NABP notes that this provision is “essential to distinguishing between state-regulated compounding and FDA-regulated manufacturing.”
Further, NABP noted its preference for not including “compounding” in the new proposed designation for a manufacturing entity because of the inference to traditional compounding and the confusion that could result, and its concern regarding the exemption for intrastate distribution of non-patient-specific sterile compounded medications, which the Association believes bear the same risk levels as non-patient-specific sterile compound products in interstate commerce. In its testimony, NABP provided information on actions taken by state boards of pharmacy and the Association in response to the fungal meningitis outbreak linked to contaminated drugs compounded by NECC. For example, the testimony included details on the NABP inspection program initiated on behalf of the Iowa Board of Pharmacy.
NABP also indicated the Association’s support for the Pharmaceutical Compounding Quality and Accountability Act in testimony presented at a US Senate Health, Education, Labor, and Pensions (HELP) Committee hearing on May 9, 2013, and in a letter (PDF) to the HELP Committee Chair, Senator Tom Harkin, and the Committee Ranking Member, Senator Lamar Alexander.

quoted from here

FDA this month signed a nearly $80,000 contract with Eastern Research Group to do an industry profile of pharmacy compounding operations, according to government spending records

Source found here FDA Seeks Contractor's Help In Profiling Drug Compounding Industry

(Daily News - 05-23-2013)

CBO Says House Rx Tracing Bill Would Generate $24 Million Over 8 Years

(Daily News - 05-31-2013)

The House version of drug tracing legislation would increase federal revenue by $24 million from 2015 to 2023 because of licensing fees, according to an analysis released Friday (May 31) by the Congressional Budget Office. The full House will consider the bill Monday under suspension of the rules alongside legislation reauthorizing animal drug user fees, according to the majority leader's schedule.

FDA MedWatch – Olympia Pharmacy Sterile Compounded Products: Recall – Concerns About Sterility Assurance | HRPP/IRB | Vanderbilt University

FDA MedWatch – Olympia Pharmacy Sterile Compounded Products: Recall – Concerns About Sterility Assurance | HRPP/IRB | Vanderbilt University

Press Release : The Illinois Department of Public Health (IDPH) is investigating two additional reports of adverse events among patients in Illinois who received injections of the steroid methylprednisolone acetate produced by Main Street Family Pharmacy, LLC in Newbern, Tennessee. All seven Illinois cases received injections at the Logan Primary Care clinic in downstate Herrin, located in Williamson County.

FOR IMMEDIATE RELEASE May 31, 2013	CONTACT: Sabrina L. Miller (312) 814-8194 www.idph.state.il.us
State Public Health Department Investigating Two Additional Steroid Injection Complications Cases Associated with Tennessee Compounding Pharmacy
CHICAGO – The Illinois Department of Public Health (IDPH) is investigating two additional reports of adverse events among patients in Illinois who received injections of the steroid methylprednisolone acetate produced by Main Street Family Pharmacy, LLC in Newbern, Tennessee. All seven Illinois cases received injections at the Logan Primary Care clinic in downstate Herrin, located in Williamson County. Initially five Illinois patients were reported to have developed abscesses after receiving injections of methylprednisolone acetate (MPA), an anti-inflammatory steroid used to treat a range of conditions including asthma and allergic reactions. The two additional cases were confirmed this week following public reports of a multistate outbreak involving more than 20 patients in Florida (13), North Carolina (2) and Illinois (7) who received injections of MPA from a shipment that originated from Main Street Family Pharmacy. IDPH is conducting a joint investigation with the Food and Drug Administration, Centers for Disease Control and Prevention and officials from other states that received shipments of MPA from Main Street Family Pharmacy. “The Illinois Department of Public Health continues to work with local and federal officials investigating these adverse events,” said IDPH Director Dr. LaMar Hasbrouck. “Our priority continues to be ensuring that all patients who might have received MPA injections have been contacted, and that they see a health care provider immediately if suffering any symptoms.” The seven Illinois cases received injections between January 3 and February 21. Investigation into the cause of the adverse events is ongoing. To date, no reports of meningitis or other life-threatening infections have been reported. Main Street Family Pharmacy has voluntarily initiated a recall of all sterile products, including MPA, in cooperation with state and federal authorities. Nearly 20 states received recalled MPA from Main Street Family Pharmacy since December 1, 2012. Main Street Family Pharmacy, LLC, is currently licensed by the Illinois Department of Financial and Professional Regulation, which is also investigating.

Illinois Department of Public Health 535 West Jefferson Street Springfield, Illinois 62761 Phone 217-782-4977 Fax 217-782-3987 TTY 800-547-0466 Questions or Comments

How Makena, a Controversial Drug to Prevent Preterm Birth, Made a Comeback (lot of discussion about compounding 17P)

By STEPHANIE GLEASON

K-V Pharmaceutical Co., KVPHQ +21.97%a small drug maker, landed in bankruptcy court last year amid disappointing sales of its flagship medicine Makena and an outcry over the drug's high price.

Today, sales of Makena, used to prevent preterm birth, are surging.

K-V slashed the price of the drug by half. But a bigger reason for the gains, say many doctors, is an aggressive K-V campaign touting Makena as a safe alternative to cheaper versions of the drug made by compounding pharmacies.

Compounders, lightly regulated pharmacies that custom-mix drugs, have long provided a less expensive version of the main ingredient in Makena. But a string of meningitis deaths late last year linked to pain medicine from a Massachusetts compounding pharmacy medicine raised concerns about the safety of such drugs. Compounded medicines aren't approved by the Food and Drug Administration.

Doctors say K-V representatives have been pressing them to switch to Makena by reminding them of the potential for malpractice lawsuits should their patients fall ill after taking a drug formulated by a compounder.

"They've been in doctors' faces a lot more about the possible harm of compounded medications," said Armando Fuentes, a maternal-fetal medicine specialist at Children's Hospital Central California. "They've really ratcheted up their marketing," he said.

K-V in a statement said the recent "tragic cases" highlighted a need for information about the differences between compounded medicines and those that carry FDA approval. The St. Louis-based company added, "K-V is taking all responsible approaches to educate health-care providers to help avoid costly and painful unintended consequences" for patients and providers.

Compounders, for their part, say the compounded version is as safe as Makena. "We cannot conclude that there is  any disparity in quality between this manufactured drug and the compounded alternative," said a representative of the International Academy of Compounding Pharmacists, David Ball, citing a June 2012 FDA analysis that tested 16 samples of the compound and found them potent and pure.

continue reading here

Virginia HAS Enacted a compounding law which requires a current inspection report before an out-of-state compounding pharmacy can be registered!

Fox Business- DANGERS OF COMPOUNDING PHARMACIES Video

view here

CDC: ‘Multistate outbreak’ from drugs linked to Tenn. pharmacy

By Chelsea Conaboy, Globe Staff
May 31, 2013 2:13 p.m.

This isn’t deja vu. The Centers for Disease Control and Prevention sent out a press release today about a “multistate outbreak of infections following steroid injections.” This time it’s not related to New England Compounding Center, the Framingham pharmacy that produced tainted drugs officials say sickened more than 700 people, and killed 55.

Federal and state regulators announced last week that seven people had developed infections after receiving a steroid made at a Tennessee compounding pharmacy. The total is now up to 20 cases in three states, and the CDC has labelled it an outbreak.

The agency said on its website that most reports were of “skin and soft tissue infections of unclear etiology.” There have been no reports of meningitis or life-threatening infections.

The new outbreak is far less severe than the one involving New England Compounding, but there are commonalities. Both were caused by injectable methylprednisolone acetate, used to treat pain and inflammation, and both involved compounding pharmacies that are supposed to make sterile, individualized drugs for patients who need special doses or formulations.

New England Compounding was operating beyond that scope by producing large batches, more like a drug manufacturer, and in unclean facilities, regulators found. Tennessee was among the states hardest hit by that outbreak, with 15 deaths.

The latest issue, involving Main Street Family Pharmacy, in Newbern, Tenn., has affected patients in Florida, Illinois, and North Carolina. The Tennessean reported that the company has surrendered its license to operate in North Carolina, where patients have had skin abscesses.

No issues have been reported regarding other drugs produced at Main Street Family Pharmacy, but the company has recalled all products which were supposed to be made with sterile processes.

“Since this matter surfaced, Main Street Family Pharmacy has done everything in its power to ensure that all potentially affected compounded medicines are recalled and no longer used by consumers or health care providers,” a company statement sent by spokesman Joe Grillo said.

quoted form here 

The Essentials of Hospital Pharmacy Compounding Conference Friday, May 31, 2013 8:30am - 3:45pm MHA Conference Center at Executive Park Burlington, MA

PROGRAM OVERVIEW

With the increased federal and state focus on regulating and monitoring compounding practices at retail-based pharmacies - hospital based pharmacies need to continue their own due diligence to ensure they are meeting both federal, state, and national standards. What is not clear is the extent of the guidelines and standards that are being used by state regulators to review hospital based pharmacies. This program will provide a comprehensive look at best practices that hospitals should be using. We will also look at the proposed state law and current regulatory practices, providing examples of best practices hospitals should be considering when conducting internal audits of their own operations. To ensure that all hospitals are meeting national standards for quality and saftey, we have also invited both legislative and regulatory agency staff to discuss their latest efforts and to hear their expectations for providers' practice. We will conclude with a reactor panel to generate further discussion and provide an opportunity for dialogue.
AGENDA
8:30am      Overview of Current Legislation & Regulatory Initiatives                    Rep. Jeffrey Sanchez
                    Member of Massachusetts House of Representatives
9:00am       Hospital & Retail Compounding Pharmacies:
                    Expectations & Best Practices                    Madeleine Biondolillo, M.D., Director, Bureau of Health
                    Care Safety & Quality, Commonwealth of MA -
                    Dept. of Public Health
9:45am       BREAK
10:00am    The Essential Quality & Safety Elements for
                    Hospital Compounding Pharmacies                    Eric Kastango, MBA, RPh, FASHP, Principal
                    CLINICALIQ, LLC & CriticalPoint, LLC
11:30am    BREAK
11:45am     Infection Prevention in Hospital Compounding Pharmacy                  
                    Keith H. St. John, MS, CIC, Director, Clinical Epidemiology,
                    Pharmacy OneSource/Wolters Kluwer Health
12:30 pm    LUNCHEON
1:15pm       Best Practices for Audits, Internal Processes,
                    and Infection Control                    William Churchill, MS, R.Ph., Chief of Service,
                    Department of Pharmacy Services
                    Brigham & Women’s Hospital
2:30pm      Break
2:45pm      Update from the National Front                   Gary Kerr, PharmD, MBA, Chief Pharmacy Officer
                   Baystate Health, Inc., & President, Massachusetts Society
                   of Health-System Pharmacists
                    Reactor Panel: What if there is an Audit at Your Hospital?                    Moderator: Gary Kerr
                    Panelists will be the speakers from the program.
                    There will be time for audience interaction, Q&A
3:45pm       PROGRAM ADJOURNS

What are Bulk Ingredients and Why are they Necessary for Compounding?

When a medical practitioner determines that a medication needs to be compounded to meet the needs of patients ... 

... it is because there is no commercially available, FDA- approved medication to fit that patient’s medical need. While there may be commercially available FDA-approved medications containing the active ingredient being prescribed, the dosage form, strength or flavor of the medication may be one that the patient physically cannot tolerate. In other cases, excipients such as fillers and preservatives found within the commercially available medication may prohibit the patient from being able to take the medication due to sensitivities or allergies to these substances.  

When a drug is customized, or compounded, to meet the identified needs of patients or groups of patients, it is common practice to use only ingredients necessary to achieve the prescribed compounded medication. This means starting with the active pharmaceutical ingredients (API) in its purist form, and then adding only the excipients necessary to achieve the prescribed dosage-form, strength, and where specified, flavor. These are the essential ingredients that make the medicine what it is, and are commonly referred to as bulk ingredients. Using bulk ingredients in a compounded medication is the surest, safest way of satisfying the prescriber’s request for medication to meet the special, customized needs of the patient.

Replacing bulk ingredients used in compounds, particularly a bulk API, with an API from an existing commercially available medication, such as a tablet or capsule, has the potential for serious health problems for those patients using that medication, for two main reasons. First, because the active ingredient makes up only a small portion of the overall ingredients used in commercial tablets or capsules, it is impossible to separate the active ingredient from the other excipients (fillers, binders, dyes, flavorings, preservatives and other materials). Without being able to separate these excipients means that they would then become incorporated into the finished compounded medication.

continue reading here

The Law of Veterinary Medicine: Question of the Day: May 31, 2013 Wouldn't It Be ...

The Law of Veterinary Medicine: Question of the Day: May 31, 2013 Wouldn't It Be ...

20 now sick in new outbreak tied to pain shots

20 now sick in new outbreak tied to pain shots

COMPLAINT IN DR. MARK W. STURDY d/b/a )ROCHESTER VETERINARY CLINIC on behalf of itself and a class, Plaintiff, v. LOWLITE INVESTMENTS, INC., doing business as OLYMPIA PHARMACY, and JOHN DOES 1-10,

The Complaint  alleges that Lowlite/Olympia violated plaintiff's (a class action-too numerous to name) rights in sending or causing the sending of unsolicited advertisements to telephone
facsimile machines in violation of the Telephone Consumer Protection Act, 47 U.S.C. §227
(“TCPA”), the Illinois Consumer Fraud Act, 815 ILCS 505/2 (“ICFA”), and the common law.  The advertisement of course was for compounded medications.  See exhibit A to complaint.  This will be a very interesting case to watch develop.

Lowlite/Olympia Has Recently Been Sued--Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic v. Lowlite Investments, Inc., d/b/a Olympia Pharmacy and John Does 1-10

filed April 30, 2013, Case Number 3:2013cv03126. Here is docket summary.  Will post copy of complaint soon. Date Filed # Docket Text 04/30/2013 1  COMPLAINT against John Does 1-10, Lowlite Investments, Inc., d/b/a Olympia Pharmacy ( Filing fee $ 350 receipt number 0753-1579273.), filed by Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. (Attachments: # 1 Exhibit A, # 2 Civil Cover Sheet, # 3 Summons)(Edelman, Daniel) (Entered: 04/30/2013) 04/30/2013 2  NOTICE of Appearance of Attorney by Daniel A Edelman on behalf of Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic (Edelman, Daniel) (Entered: 04/30/2013) 04/30/2013 3  NOTICE of Appearance of Attorney by Dulijaza Julie Clark on behalf of Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic (Clark, Dulijaza) (Entered: 04/30/2013) 04/30/2013 4  MOTION to Certify Class by Plaintiff Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. Responses due by 5/17/2013 (Edelman, Daniel) (Entered: 04/30/2013) 04/30/2013 5  MEMORANDUM in Support re 4 MOTION to Certify Class filed by Plaintiff Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. (Attachments: # 1 Exhibit A, # 2 Exhibit B)(Edelman, Daniel) (Entered: 04/30/2013) 04/30/2013 6  NOTICE of Appearance of Attorney by Michelle R Teggelaar on behalf of Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic (Teggelaar, Michelle) (Entered: 04/30/2013) 04/30/2013 7  MOTION to Continue and enter Plaintiff's Motion for Class Certification by Plaintiff Dr. Mark W. Sturdy d/b/a Rochester Veterinary Clinic. Responses due by 5/17/2013 (Clark, Dulijaza) (Entered: 04/30/2013) 05/02/2013    TEXT ORDER by Magistrate Judge Byron Cudmore: Plaintiff's Motion to Enter and Continue Plaintiff's Motion for Class Certification 7 ALLOWED in that Plaintiff's Motion for Class Certification 4 will remain of record and taken under advisement until the parties are at issue. The ECF response date from Motion 4 is stricken. Plaintiff to take steps to serve Defendants. (LB, ilcd) (Entered: 05/02/2013) 05/15/2013 8  Summons Issued as to Lowlite Investments Inc.. Original returned to attorney for service. (MJ, ilcd) (Entered: 05/15/2013)

FLASHBACK: Olympia Pharmacy Was One of The Pharmacies That Forced the FDA to Get A Warrant in Order to Inspect

The New York Times reported that Olympia Compounding Pharmacy in Orlando forced the FDA to get a warrant in order to enter and inspect the pharmacy.  Scott A. Livingston, Olympia’s lawyer,  said the pharmacy required the warrant because it was concerned about patient privacy.  

Who Will Be the Compounding Pharmacy Exhibitors At These Upcoming Veterinary Conferences?

6/12/2013 - 6/16/2013Sun & Fun Veterinary Conference

6/20/2013 - 6/23/2013PACVET Conference

6/27/2013 - 6/30/2013North Carolina VMA

Question of the Day: May 31, 2013 In Doing Research For this Blog, I Find It Unreal that Without Even Looking I Saw Three Job Openings Relating to Sales or Marketing Reps at Compounding Pharmacies

Is it odd that Pharmacies Seem to Be Expanding in the Compounding World With All the Negativity Surrounding Them Right Now?  Wouldn't One Expect More Pharmacists and Pharmacies to Be Cautious in this Area?  Is the Expansion Just a Sign of the Greed? Or is it simply that Pharmacies and Pharmacists See A Need in this Area at this Time?

IMPORTANT: CDC calls illnesses associated with TN compounder an outbreak--17 states now included

The U.S. Centers for Disease Control and Prevention on Thursday classified illnesses associated with medicines made by a compounding pharmacy in Newbern, Tenn., as an outbreak.

The CDC launched a website to offer guidance on suspected infections among people who received preservative-free methylprednisolone acetate (MPA) 80mg/mL in 10mL vials produced by the Main Street Family Pharmacy. This is the same steroid medicine formerly made by New England Compounding Center linked to last year’s fungal meningitis outbreak.

“The majority of these persons developed skin and soft tissue infections of unclear etiology following intramuscular injection of this product,” the CDC said. “Additional clinical information is being gathered. To date, no reports of meningitis or other life-threatening infections have been reported.”

Question of the Day: May 30, 2013 Isn't it Unbellieveable that No State Seems to Really Knows How Many Pharmacies Compound Mediciations in their State or Ship into Their State, and in some cases

state board of pharmacy don't know how many compounding pharmacies they inspected last year?

One example of this is Texas.  When you research a pharmacy on Texas State Board of Pharmacy (TSBP) website the information for compounding-especially sterile compounds may contain no information simple because the pharmacy failed to submit it; not became it does not do sterile compounds.  It is my understanding that TSBP is working on correcting this flaw in its system. Another example, Oklahoma Board of Pharmacy does not keep track of inspections other than the total number of pharmacies it inspects in a year.  States simple must do a better job of gather, collecting and publicizing this type of information, but his takes resources and money in the budget.

La. pharmacists, patients debate proposed regulation

BY BILL LODGE

Advocate staff writer

May 30, 2013

0 COMMENTS

Pharmacists and patients concerned about the impact of new regulations by the Louisiana Pharmacy Board wanted to know Thursday why limits are proposed for sales of specialty medicines directly to physicians.

Malcolm J. Broussard, the board’s executive director, fielded questions during a public hearing at the board’s meeting room. No board members were present.

Broussard said the impetus for limiting such sales to 10 percent of a compounding pharmacy’s patient-prescription business can be seen in the misery caused last year by contaminated medicines from a Massachusetts company.

Dozens of people across the nation died from fungal meningitis traced to the Massachusetts company’s products.

“We haven’t heard from a (Louisiana) pharmacy yet that this rule would put them out of business,” Broussard added.

continue reading here

Compounded Drug Infects 13 Florida Patients

By CAROL GENTRY

Thirteen Florida patients have developed skin infections after receiving steroid injections shipped into the state from a compounding pharmacy in Tennessee, Florida health officials have reported.

None of the 13 cases is thought to be life-threatening, according to a release from the Florida Department of Health. The patients developed skin abscesses on their hips near the spot where they received a shot.

continue reading here

How A Compounding Pharmacy Can Fill Prescriptions A Regular Pharmacy Cannot

By Marjorie Vargas

There is a specialized type of pharmacy that can produce medications that are needed in another form not currently available in the standard produced form. This facility is called a compounding pharmacy and is still run by a registered pharmacist. This can be a lifesaver for many patients who cannot get their medications any other way.

Compounding was the original way drugs were manufactured and distributed to patients, with naturally found ingredients being incorporated to make dyes, perfumes, and eventually healing components. The earliest concoctions included oils from both plants and animals. Many, many years ago, before the acceptance of more commercial facilities, all of them were doing compounding. This was the accepted method for getting and distributing medications to the people who needed them.

- See more at: http://lifefetness.blogspot.com/2013/05/how-compounding-pharmacy-can-fill.html#sthash.X8Nakv1G.dpuf

15 states including Alabama, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee, Montana, Oklahoma, and Texas where the products were distributed from Mainstreet so more than 7 states are now involved

According to news reports, we know North Carolina, Tennessee and Arkansas are investigating Main Street Pharamcy in light of the recall.  What about the other states?  What are they doing?

Arkansas investigating product from compounding pharmacy 1:54 PM, May 30, 2013

LITTLE ROCK, Ark. -- The Arkansas Department of Health along with federal health organizations and other states are investigating reports of infections among 20 patients in Illinois (5), North Carolina (2), and Florida (13) who received injections of a steroid, methylprednisolone acetate (MPA), after Dec. 6, 2012, produced by Main Street FamilyPharmacy, LLC, (MSFP) in Newbern, Tenn. Complications identified thus far appear to be limited to skin abscesses at the site of injection and joint infections. There are no reports of meningitis, stroke or death.

Ten clinics in Arkansas have received MPA from the MSFP. All ten have been contacted and are assembling information to assist in the investigation. Individuals who are experiencing any unexplained health problems following an injection of methylprednisolone acetate from one of these clinics are encouraged to contact the clinic or their regular health care provider.

Why does Nancy Loomis, RPh have an active license with ZERO discipline recorded, not even a public complaint, when the pharmacy she owned and operated as a supervising pharmacist plead GUILTY to a FELONY?)

I  have previously posted about Signature Pharmacy which was located in Orlando, Florida  See links below.  Guess who was an owner in Signature Pharmacy and guess who is an owner in Olympia Pharmacy, which just initiated a volunteer recall.  You will want to read Dr. Ken Woliner's post below the previous post on this blog about Signature.

NY judge tosses convictions in Fla. steroids case

New details in DA's admonishment in Signature Pharmacy case

Orlando pharmacy pleads guilty to drug charge Signature Compounding Pharmacy of Orlando sold steroids 

Plea deal ends years-long steroids case No individual criminal charges against operators of former Florida pharmacy Times 

Signature Compounding case Lawsuit against Soares dropped Case facing Albany County prosecutor ends after pharmacy admits felony

Written by Dr. Ken Woliner, MD, ABFM

www.holisticfamilymed.com

Olympia Pharmacy is owned by Nancy and Stan Loomis (with Nancy Loomis, R.Ph. being the prescription department manager). These are the same owners of the defunct Signature Pharmacy that was the center of "Operation Which Doctor" that Albany County (NY) State Attorney prosecuted against this pharmacy and several "rejuvenation clinics"

Lowlite Investments Inc, doing business as Olympia Pharmacy in Orlando, Florida, has initiated a voluntary recall of all unexpired sterile drug products compounded by the pharmacy because of a lack of sterility assurance.

Lowlite Investments Inc, doing business as Olympia Pharmacyin Orlando, Florida, has initiated a voluntary recall of all unexpired sterile drug products compounded by the pharmacy because of a lack of sterility assurance.

"The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility," the company says in a press release posted May 29 on the FDAWeb site.

The affected product was compounded between December 17, 2012, and March 27, 2013. The recall includes all sterile products that Lowlite supplied to patients and offices of licensed medical professionals with a use-by date of September 25, 2013, or earlier.

A complete list of the recalled products, lot numbers and expiration dates can be found on the FDA Web site.

The recall is being conducted as a "precautionary measure," the company says. To date, they have not received any reports of injury or illness associated with the recalled product. However, "in the event a sterile product is compromised patients are at risk for serious and possible life threatening infections."

Lowlite is notifying customers by telephone, fax, or mail to return the products to the pharmacy.

Source found here

NABP Surveyors to Assist With New Jersey Compounding Pharmacy Inspections Under Contract With the State

Under a contract with the New Jersey Division of Consumer Affairs (Division) and the state’s Attorney General Jeffrey S. Chiesa, NABP will assist the Division with inspections of New Jersey pharmacies engaged in the practice of compounding. The planned pharmacysurveys will expand the Division’s already robust inspections of compounding pharmacies. As noted in a Division press release, New Jersey State Board of Pharmacy regulations hold compounding pharmacies to “stringent compounding standards, mirroring those of the U.S. Pharmacopeial Convention” and the Division’s inspectors have routinely inspected the state’s pharmacies to ensure compliance with regulations. The contract with NABP will enable New Jersey “inspectors to draw upon a greater body of expertise and experience to address this growing industry,” indicates Chiesa. Chiesa stated further that the Division “will act immediately on any violations that appear to threaten the public’s health and safety.” The expanded compounding pharmacy inspections have been initiated as a result of contamination issues discovered at Med Prep Consulting, Inc, in Tinton, NJ, and similar reports of contamination at compounding facilities in other states, as well as the fungalmeningitis outbreak linked to contaminated products compounded by the New England Compounding Center in Framingham, MA. New Jersey’s contract with NABP enables the Division to temporarily employ NABP inspectors on an as-needed basis. 

Similar inspection programs are under consideration in a number of other states, and NABP is in discussion with these states regarding how the Association can assist with these efforts to ensure the safety of compounded medications. In addition, NABP plans to establish an e-Profile for each pharmacy in the US, which will include verifications of licensure, disciplinary checks, and verification that a timely and robust inspection has occurred for each pharmacy, including those performing sterile and nonsterile compounding. The information in the e-Profiles for pharmacies will be sent proactively to boards of pharmacy for use in making licensure and registration determinations for nonresident pharmacies. 

A compounding inspection program conducted by NABP on behalf of the Iowa Board of Pharmacy was initiated in mid-December and is ongoing. More information about the Iowa compounding pharmacy inspection program and the information sharing network under development by NABP is included in the April 2013 NABP Newsletter article “Compounding Pharmacy Information Sharing Network Available to Boards Soon” (PDF).

quoted from here

May 30, 2013: Rep. Markey Introduces Bill to Support Compounding of Drug Products

---

Rep. Markey Introduces Bill to Support Compounding of Drug Products
Bill Introductions-House
Copyright © Targeted News Service, 2013
2013-05-30

by KAREN NARAG

WASHINGTON, May 30 -- Rep. Edward Markey, D-Mass., has introduced legislation (H.R. 2186) to amend the Federal Food, Drug, and Cosmetic Act to "provide for the compounding of drug products."

----

Contact: Eben Burnham-Snyder, Rep. Ed Markey, 202-225-2836

Follows Investigation Showing Lax Oversight of Compounding

WASHINGTON (May 23, 2013) – After his recent report showed that some states across the country are turning a blind eye to the risks of compounding pharmacies, Rep. Ed Markey (D-Mass.) today introduced new legislation to make compounding pharmacies safer for patients. The legislation will strengthen federal regulations for compounding pharmacies, especially high-risk sterile compounding and compounding pharmacies that ship drugs across state lines.

An investigation led by Rep. Markey and his Energy and Commerce Committee colleagues found last month that compounding pharmacies are going largely untracked, unregulated, and under-inspected by states across America, demonstrating the need for more federal oversight of the industry. Many of the risks from compounders were revealed following the 55 deaths and 741 illnesses in 20 states that originated from drugs created at the New England Compounding Center located in Rep. Markey’s Congressional District.

“We know some compounders are acting more like large drug manufacturers. We know that patients continue to be at risk for injury or death. And we know that some states are not doing their jobs to protect patients,” said Rep. Markey. “That’s why we need legislation that gives FDA more authority, while still allowing smaller mom-and-pop compounders to do their work for their patients.”

Massachusetts Governor Deval Patrick today praised Rep. Markey for his leadership on compounding pharmacy oversight. Governor Patrick has instituted a top-to-bottom review and proposed actions to increase the health and safety of compounding pharmacies in Massachusetts following the NECC tragedy.

“Congressman Markey’s legislation, coupled with the important steps we took at the state level, is critical to closing a regulatory gap created over the past several years for a variety of reasons,” said Governor Deval Patrick. “I commend Congressman Markey for his leadership. No one should live in fear that their medicine is unsafe.”

The legislation, the VALID Compounding Act, updates previous legislation introduced in 2012 by Rep. Markey. Original co-sponsors of the bill are Louise Slaughter (D-N.Y.), WM. Lacy Clay (D-Mo.), and Charles Rangel (D-N.Y.).

A one-pager on the VALID Act is available HERE, and the legislation includes the following main elements:

--Provides the FDA with sole regulatory authority over compounding pharmacies that engage in interstate commerce and high-risk sterile compounding without or in advance of a prescription. 

--Preserves State regulatory authority for traditional small compounding pharmacies. 

--Allows compounding pharmacies to compound drugs before receiving prescriptions for the drug provided that they register with the FDA and meet specified safety standards, and allows capable State regulators to oversee these pharmacies.  

--Increases communication between the States and federal government.

--Increases transparency to patients and consumers.

A full copy of the legislation can be found HERE and a section-by-section document HERE.

“This bill will save lives because it improves safeguards for all types of important medications made by the largest compounding pharmacies,” said Diana Zuckerman, PhD, president of the Cancer Prevention and Treatment Fund and National Research Center for Women & Families. “At the same time, it protects the thousands of small 'Mom & Pop' traditional compounders that some patients need.”

The legislation has been endorsed by the National Consumers League, National Research Center for Women and Families, Cancer Prevention and Treatment Fund, National Women’s Health Network, Our Bodies Ourselves, Union of Concerned Scientists, U.S. PIRG, Community Catalyst, The TMJ Association, and WoodyMatters. A copy of the endorsement letter can be found HERE

US House Shows Little Support for Senate Version of Compounding Bill

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The Sterility Risks in Pharmacy Compounding Can Be Limited, Not Eliminated, Experts Stress at USP Forum May 29th, 2013

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Louisiana Proposed Rule Changes: Some pharmacists concerned about proposed rule changes By Bill Lodge Advocate staff writer

Proposed changes in regulations could push some pharmacists out of the specialty medicine business in Louisiana, according to a Baton Rouge pharmacist with 37 years of experience.
Patricea Angelle, a compounding pharmacist in Baton Rouge, said the rule changes would impose an enormous cost burden on some compounding pharmacies and create serious problems for patients who depend on the medicines they provide.
Compounding pharmacies prepare medicines prescribed for patients with allergies or other negative reactions to some medications they need in order to recover from illness or injury.
Some of those special medicines may be needed by patients for whom other medications simply don’t work. Compounding pharmacists also prepare medicines that some physicians want to keep stocked at their offices.
Malcolm J. Broussard, executive director of the Louisiana Board of Pharmacy, said he hasn’t “heard from any pharmacies telling us the proposed rule would force them to close.”
If so, others will fill those gaps, Broussard said.
A public hearing on the pharmacy board’s proposals is scheduled for 1 p.m. Thursday at the board office, 3388 Brentwood Drive.
The proposed rule changes in Louisiana follow an incident late last year in which dozens of recipients of medicines from a compounding pharmacy in Massachusetts contracted fungal meningitis and died.
The Louisiana Board of Pharmacy declared an emergency in January, and members announced they planned to adopt a rule that would bar the state’s compounding pharmacists from deriving more than 10 percent of their business from the sale of medicines by purchase order to physicians for use at their offices.
“The quality and safety standards for products made pursuant to a purchase order are ordinarily more stringent than the quality and safety standards for preparations made pursuant to a patient-specific prescription,” Broussard, said in an email exchange this week.
“When pharmacies make products pursuant to purchase orders in compliance with the less stringent standards applicable to patient-specific prescriptions, there is a potential risk,” Broussard added. “The proposed rule is an attempt to mitigate that risk by limiting such activity to no more than 10 percent of a pharmacy’s activity.”
In Washington, D.C., Sarah Dodge, the International Association of Compounding Pharmacists’ vice president for government affairs, said such rules seem arbitrary.“That concerns us,” Dodge added.
Dodge explained that one proposed federal law calls for greater controls on compounding pharmacies that send sterile compounds across state lines to recipients who are not patients.
Inside one state’s boundaries, Dodge said, “What we prefer is that the state allow what has been usual for (physicians’) office use.” She said her organization does not support an arbitrary cap.
“The federal proposal is far more palatable than the Louisiana proposal,” Dodge said.
Broussard said, “In the event a pharmacy is currently preparing more than 10 percent of itsactivity pursuant to (physicians’) purchase orders, that pharmacy will need to make a business decision.”
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FDA to Once Again Allow Import of Unapproved Drugs to Solve Shortages

29 May 2013

By Alexander Gaffney, RF News Editor

Responding quickly to congressional pressure and the needs of critically ill neonates, the US Food and Drug Administration (FDA) today announced that it would allow the import of several types of [Read More...] 

Edwards, Hospira Warn Investors of Receipt of FDA Warning Letters

30 May 2013

By Alexander Gaffney, RF News Editor

Two major life sciences companies, Hospira and Edwards Lifesciences, have separately warned their respective investors about their receipt of Warning Letters from the US Food and Drug Administration [Read More...]