Source: https://www.lawofcompoundingmedications.com/2012/06/
Timestamp: 2019-04-20 07:09:01+00:00

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The material below may be found here.
or suggested in the labeling."
b. List all drugs imported or offered for import into the U.S.
- Must be physically located in the U.S.
c. Drug products not for importation into the U.S.
the contemplated research, teaching, analysis, etc.
of the exemptions. If not, then misbranded [502(F)(1)].
US Pharm. 2009;34(11):66-68. Here is a sobering thought. A pharmacist makes a mistake. The error results in the death of a patient, and the pharmacist is charged with negligent homicide. He is found guilty of involuntary manslaughter and faces up to 5 years in prison and a maximum fine of $10,000. Of course, his pharmacist license is revoked and chances are he will never work in the profession again. His crime? He did not check the accuracy of calculations used by a pharmacy technician under his charge to compound the concentration of sodium chloride in a prescription for a cancer chemotherapy solution.
Negligent? Yes. Accountability and responsibility? Yes and Yes. Malpractice? Yes. Loss of license? Yes. Guilty? Yes. But a crime? Prison term? For a mistake, albeit a mistake with a worst-case outcome? That is tough medicine to swallow. More important, how is justice served by putting this pharmacist in jail? The message to pharmacists and perhaps all other health care practitioners—watch out. There may be prosecutors out there just itching to put you away.
bnd.com on May 25, 2012 reported that a St. Louis County cancer doctor has been sentenced to probation for two years, fined $25,000 and ordered to pay $1 million for misbranded prescription drugs. The penalties for Dr. Abid Nisar of Town and Country, Mo., were announced Friday. He pleaded guilty to federal charges earlier this year. As part of an agreement with prosecutors, Nisar will pay $1 million to resolve allegations that he submitted false claims for payment through several programs, including Medicare. Nisar is also banned from participation in federal health care programs for seven years.
A Plattsburgh pharmaceutical company and its president, a Canadian citizen, were fined $15,000 this week for mislabeling more than $1 million worth of human growth hormone that was imported from China and distributed to pharmacies around the country.
The case has ties to a 2007 investigation by the Albany County district attorney's office targeting pharmaceutical companies that illegally sold steroids and other anti-aging drugs.
Antonio Dos Santos, 63, of Montreal and Plattsburgh-based Medisca, Inc., also must forfeit $1.76 million to the U.S. government. Dos Santos and the company pleaded guilty to misdemeanor federal drug charges last October in Albany.
U.S. Magistrate David R. Homer this week ordered Dos Santos to pay a $5,000 fine and the company to pay $10,000.
A former Orlando pharmacy, Signature Compounding Pharmacy, whose owners and operators are under indictment, was among the customers of Medisca, Inc., which also has a corporate office in St. Laurent, Quebec.
John L. Pacht, an attorney from Burlington, Vt., entered a guilty plea on behalf of Medisca last fall.
Plea agreements signed by Dos Santos and Pacht said that between July 2004 and February 2007 Medisca imported 1,737 grams of human growth hormone from China. The criminal accusation is that the company marketed the drug as an "FDA approved drug" which is false, federal prosecutors said.
Dos Santos founded Medisca in 1989. The $1.76 million forfeiture represents the company's gross profits from the unlawful drug sales.
The company ceased importing human growth hormone in February 2007. That month, a multi-agency task force raided Orlando's Signature Compounding Pharmacy. The arrests of Signature's operators were made on warrants filed by Albany County prosecutors who obtained felony indictments against Signature's operators related to the alleged sale of performance-enhancing drugs, including steroids, to customers that included pro athletes and celebrities.
Albany County prosecutors have said Medisca was a primary supplier of Signature pharmacy.
Albany prosecutors allege in their charges that Signature was selling growth hormone to people nationwide who had no legitimate medical reason for the drug.
The plea agreements require Medisca face spot checks by the U.S. Food and Drug Administration for one year. The company must pay the costs of those inspections.
Dos Santos had faced up to a year in prison and a fine of up to $100,000.
Records show Dos Santos, who founded Medisca in 1989, pleaded guilty to a similar charge for illegally importing shipments of minoxidil (Rogaine), a hair-growing product, from Canada into the United States in 1989, when it was prohibited.
The Minnesota conviction was vacated in 2007 after Dos Santos' lawyers filed a motion arguing his plea was flawed and that minoxidil is now approved for distribution in the United States.
DAVID PITT, Associated Press Copyright 2012 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
DES MOINES, Iowa (AP) — A woman left with eye problems when she didn't get the right medication after surgery won't get a new trial in her lawsuit against a pharmacy, even though new evidence that surfaced as the trial was beginning surprised her attorney, the Iowa Supreme Court ruled Friday.
The case centered on medication prepared by C.R. Pharmacy Service, which does business as Fifth Avenue Pharmacy. The medication was to be applied by Misty Whitley's doctor immediately after surgery. However, after Whitley developed problems, it was discovered she did not get the right medication.
Whitley, of Marengo, sued Dr. Lee Birchansky and the Cedar Rapids pharmacy in 2007 but dropped Birchansky from the lawsuit and pursued a malpractice and negligence claim against the pharmacy claiming it supplied the wrong product for her surgery. A jury found a verdict in favor of the pharmacy.
Whitley has since filed a new lawsuit against Birchansky after the pharmacy manager discovered documents that indicated the medication ordered by Birchansky had not been picked up by his office from the pharmacy until after the surgery had been completed.
Those documents were at the heart of the appeal that led to the Supreme Court's decision Friday. The manager who discovered the documents a few weeks before the trial told his attorney. However, that information was not passed on to Whitley's attorney.
The Supreme Court found the pharmacy's attorney violated a duty to disclose the new information, but it said the judge did nothing wrong in allowing the evidence. The judge delayed the trial so Whitley's attorney could explore the new evidence and interview additional witnesses.
The saga began when Whitley went to the Fox Eye Clinic in Cedar Rapids in 2005 hoping to improve nearsightedness with a procedure that involves using a laser to sculpt the shape of the cornea. Then, in March 2006, she had a corneal scraping procedure to repair scarring of the cornea in both eyes, a common risk with laser eye surgery.
After that surgery, her eyes developed signs of cataracts and glaucoma. An investigation and testing revealed the substance applied to her eyes after surgery was not the medicine ordered by her ophthalmologist Birchansky.
She had to undergo corneal transplant surgery. After a subsequent accident, she lost her left eye.
Whitley asserted the pharmacy delivered the wrong prescription, which the doctor applied to her eyes. The pharmacy maintained it delivered the correct prescription and the doctor mistakenly applied the wrong substance.
Then, at the beginning of the trial, the pharmacy's attorney said it could not be at fault because it didn't deliver the medication before the surgery took place. The attorney disclosed the documents on the second day of the trial during questioning of the doctor.
Whitley's attorney wanted the evidence excluded from the trial, but the district court judge denied that request.
The Iowa Court of Appeals ordered a new trial, finding that the surprise Whitley's attorney encountered by the new evidence was too prejudicial for the district court to refuse to exclude the evidence.
The Supreme Court reversed that decision and agreed with the district court judge that the evidence should have been allowed.
"The district court did not abuse its discretion when it made its decision to grant a continuance and deny the request to exclude the evidence," the justices wrote. "Based on the circumstances existing at the time the decision was made, the trial court pursued a reasonable course of action."
Robert Breckenridge, of Ottumwa, who represented Whitley, said he continues to believe the conduct of the pharmacy's attorneys should not have been rewarded by the court.
Court records show a scheduling conference in the lawsuit against Birchnasky is set for July 24.
Birchansky's attorney, Hayward Draper, of Des Moines, said the case was dropped against the doctor the first time because Whitley's attorneys concluded the doctor provided good care and did nothing wrong in his treatment of her.
"The new lawsuit is completely without merit because Dr. Birchansky did provide good care and did do nothing wrong," Draper said.
An attorney for the pharmacy, Chris Bruns, of Cedar Rapids, said the pharmacy had not authorized him to comment further about the case.
To review the Iowa Supreme Court decision click here.
This rule is effective December 16, 2011.
Lisa M. Troutman, Center for Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, (240) 276-8322, email: lisa.troutman@fda.hhs.gov.
Intervet, Inc., 556 Morris Ave., Summit, NJ 07901, filed NADA 141-325 that provides for the veterinary prescription use of INCURIN (estriol) Tablets for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs. The NADA is approved as of July 24, 2011, and the regulations are amended in 21 CFR part 520 to reflect the approval.
A summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning on the date of approval.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.
(a) Specifications. Each tablet contains 1 milligram (mg) estriol.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1) Amount. Administer at an initial dose of 2 mg per dog per day. The dosage may be titrated to as low as 0.5 mg per dog every second day, depending on response.
(2) Indications for use. For the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Director, Center for Veterinary Medicine.
Andrew J. Strempler, a Canadian citizen, was arrested by United States officials in Florida and faces charges relating to his operation of a Web site selling drug products to US residents including distribution of counterfeit and non-Food and Drug Administration (FDA)-approved drugs. “According to the indictment, from around January 2005 through June 9, 2006, Strempler and his co-conspirators unlawfully enriched themselves by selling prescription drugs to individuals in the United States, falsely representing that RxNorth was selling safe prescription drugs in compliance with regulations in Canada, the United Kingdom and/or the United States. The indictment further alleges that Strempler obtained the prescription drugs from various other source countries without properly ensuring the safety or authenticity of the drugs. In fact, the indictment alleges that some of the drugs sold by Strempler included counterfeit drugs,” indicates a press release from the US Attorney’s Office, Southern District of Florida. Strempler faces one count of conspiracy to commit mail fraud and wire fraud, in violation of Title 18, US Code, Section 1349, and two counts of mail fraud, in violation of Title 18, US Code, Section 1341. The government is also seeking forfeiture of $95 million.
Wifredo A. Ferrer, US attorney for the Southern District of Florida stated, “FDA regulations are designed to promote and ensure the safety and integrity of prescription drugs sold and used in the United States. The US Attorney’s Office is committed to assisting the FDA enforce these regulations to protect American consumers from unsafe, adulterated and counterfeit drugs.” David W. Bourne, special agent in charge, FDA, Office of Criminal Investigation (OCI), Miami Field Office, stressed that the FDA OCI is committed to “aggressively pursuing individuals” who seek to sell counterfeit, adulterated, and misbranded drug products to US consumers via the Internet. Strempler appeared in federal court on June 14, 2012, before US Magistrate Judge John O’Sullivan. If convicted, Strempler faces a possible maximum statutory sentence of up to 20 years in prison on each count.
Additional details about the charges against Strempler are available in the US Attorney’s Office press release. The indictment (PDF) is available for download from the Department of Justice Web site. The press release notes that an indictment is only an accusation and a defendant is presumed innocent until proven guilty.
3. Invalid prescriber DEA numbers.
effort to enter valid and accurate information.
the generic name and the name of the manufacturer.
(C) The directions for the use of the drug.
items listed in subdivision (a)(1).
elements specified in paragraph (1) of subdivision (a).
To read remainder of new rule, click here.
Dr. Belden was present at the meeting and was represented by counsel, Daniel Bachi. Dr. Belden was sworn in by the court reporter.
Ms. Lewis was recused due to her participation on the probable cause panel.
Ms. Henderson presented the case as a settlement stipulation. Ms. Henderson advised the board the administrative complaint alleges the Respondent administered Stanzolol and Butorphanol without adhering to statutory record keeping requirements. Ms. Henderson advised the board the department recommended a fifteen hundred dollar ($1,500.00) fine, one thousand nine hundred and sixty two dollars and eighty five cents ($1,962.85) in costs and six (6) months probation.
After discussion by the board the following motion was made.
MOTION: Dr. Maxwell made a motion to accept the settlement stipulation as presented.
SECOND: Dr. Helm seconded the motion and the motion passed unanimously.
The Pharmacy Practice Act Rule (Rule R156-17b) in Utah that are in effect as of June 1, 2012, relating to Pharmacies and Compounding can be found here.
The Texas State Board of Pharmacy proposes amendments to §291.131, concerning Pharmacies Compounding Non-Sterile Preparations, and §291.133, concerning Pharmacies Compounding Sterile Preparations. The proposed amendments, if adopted, clarify the requirements for the recall of compounded preparations.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rules are in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rules.
Ms. Dodson has determined that, for each year of the first five-year period the rules will be in effect, the public benefit anticipated as a result of enforcing the rules will be to ensure that the proper recall procedures are being practiced by pharmacies that are compounding sterile and non-sterile preparations. There is no fiscal impact for individuals, small or large businesses, or to other entities which are required to comply with these sections.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8008. Comments must be received by 5:00 p.m., July 31, 2012.
The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
(7) Drugs, components, and materials used in non-sterile compounding.
(I) A pharmacy may not compound a preparation that contains ingredients appearing on a federal or state agency [Food and Drug Administration ] list of drug products withdrawn or removed from the market for safety reasons.
(1) The pharmacy shall have written procedures for the recall of any compounded non-sterile preparations provided to a patient, to a practitioner for office use, or a pharmacy for administration. Written procedures shall include, but not be limited to the requirements as specified in paragraph (3) of this subsection.
(2) The pharmacy shall immediately initiate a recall of any non-sterile preparation compounded by the pharmacy upon identification of a potential or confirmed harm to a patient.
(F) the pharmacy keeps a written record of the recall including all actions taken to notify all parties and steps taken to ensure corrective measures.
(4) [(3)] The board may require a pharmacy to initiate [institute ] a recall if there is potential for [probable ] or confirmed harm to a patient.
(10) Drugs, components, and materials used in sterile compounding.
(H) A pharmacy may not compound a preparation that contains ingredients appearing on a federal or state agency [Food and Drug Administration ] list of drug products withdrawn or removed from the market for safety reasons.
WASHINGTON (AP) — President Obama is expected to sign into law a mammoth bill passed by Congress Tuesday that reshapes how the Food and Drug Administration assures the safety of the drug supply, particularly imported medicines.
The bill is a must-pass piece of legislation because it extends the 20-year program that helps fund the FDA's budget for reviewing new drugs and medical implants. But lawmakers added dozens of provisions influencing FDA policies and the drug industry.
FOREIGN INSPECTIONS: Gives the FDA more leeway to inspect drug factories in China, India and other foreign countries. FDA has long been required to inspect U.S. manufacturing sites every two years, but most drug ingredients are now made overseas. The bill frees FDA inspectors to go after foreign drug plants.
COUNTERFEIT DRUGS: Hikes the maximum penalty for drug counterfeiting to $4 million or 20 years in prison. The current maximums are $10,000 or three years in prison. Drug counterfeiting has risen steadily over the past decade, and drugmakers reported more than 1,700 worldwide last year. The FDA is investigating two faked batches of the cancer drug Avastin that reached the U.S. this year from the Middle East by way of European supply chains.
FDA REVIEW FEES: Renews, through 2017, a program under which drugmakers pay the FDA to review new medications. For the first time, it also requires generic drugmakers to pay for reviews, adding $299 million in annual fees to the $693 million paid by makers of branded drugs. The bill also renews a similar program for reviews of medical devices.
BREAKTHROUGH DRUGS: Relaxes certain requirements — including allowing smaller and shorter clinical studies — to speed approval of drugs that appear to offer innovative treatments for life-threatening diseases.
OUTSIDE INSPECTORS: Allows drugmakers to hire non-government inspectors to assess whether factories are meeting U.S. quality standards. These inspections wouldn't take the place of the FDA's but could be used to bolster a company's safety record.
DRUG SHORTAGES: Requires drugmakers to notify the government at least six months before discontinuing production of a drug. More than 280 drugs are currently in short supply, creating life-threatening delays for patients with cancer and other serious diseases. The shortages are driven by factors including consolidation in the pharmaceutical industry.
SYNTHETIC DRUGS: Bans 28 chemicals used in synthetic drugs known as "bath salts" that are often sold at corner stores as hygiene products, incense or plant food and can trigger bizarre and violent behavior.
The final version of Senate Bill 3187 as passed and headed ot the President's desk can be read by clicking here.
SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING.
‘(aa) If it is a drug, or an active pharmaceutical ingredient, and it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required by section 744A(a)(4) or for which identifying information required by section 744B(f) has not been submitted, or it contains an active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility.’.
Thanks to ASHP’s multi-year effort to educate Congress about the public health crisis caused by drug shortages, along with work to build broad based support for the legislation in the health care community, we are closer than ever to protecting patients from the dangers posed by drug shortages. Today, the Senate passed the final version of S. 3187, “The Food and Drug Administration Safety and Innovation Act,” which included ASHP-supported drug shortages provisions. The House of Representatives passed the bill last week. The bill now goes to the President for his signature.
ASHP is widely viewed as the most credible source of information on drug shortages. In a year when Congress experienced inertia due to partisan disagreements, the Society took the lead in bringing both parties together to help address the drug shortages crisis in a bipartisan, rational, and thoughtful manner. The Society, in collaboration with key partners, including the American Hospital Association (AHA), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), and the Institute for Safe Medication Practices (ISMP), worked closely with legislators to develop the drug shortages provisions.
ASHP championed the provision which became the centerpiece of the drug shortages legislation –an early notification system that requires drug manufacturers to notify the Food and Drug Administration (FDA) of production problems or if a product will be discontinued. Failure to comply with the early notification requirement will trigger a letter from FDA.
The bill also gives the FDA authority to expedite the review of products and new drug applications; creates a generic user fee program; and allows for repackaging of medications in short supply to be used within the same health system.
Several pharmacies in the Charlotte, NC, area have been approached by questionable drug wholesalers attempting to sell them drug supplies that may be fake, reports WSOCTV. One pharmacy owner indicated that he received calls from companies claiming to be new wholesalers on a daily basis. He indicated further that he avoids working with such companies for fear that they may be distributing dangerous counterfeits, and that he only buys drug supplies directly from the drug manufacturer.
In an April 2012 FDA statement, the agency urges the health care community “to examine their purchasing practices to ensure that they buy directly from the manufacturer or from licensed wholesale drug distributors in the United States.” The statement was issued following FDA’s action of requesting that medical practices in several states stop administering drugs purchased from any foreign or unlicensed source. In the statement, FDA notes that the “Verify Wholesale Drug Distributor Licenses” FDA Web page may be used to verify that a wholesale drug distributor is licensed in the state(s) where it is conducting business. Also, suspected criminal activity can be reported to FDA's OCI by calling 800/551-3989 or completing the online form on the OCI Web Site.
Another way that pharmacies can be assured of the legitimacy of a wholesale distributor is to look for NABP’s Verified-Accredited Wholesale Distributors® (VAWD®) Seal. Those wholesale distributors that achieve VAWD accreditation are in compliance with state and federal laws and NABP's VAWD criteria. Wholesale distributers that display the VAWD Seal as part of their accreditation have undergone a criteria compliance review, including a rigorous review of their operating policies and procedures, licensure verification, survey of facility and operations, background checks, and screening through the NABP Clearinghouse. Accredited facilities are reviewed annually and undergo a site survey every three years. Created in 2004, the accreditation program plays a pivotal role in preventing counterfeit drugs from entering the US drug supply.

References: § 510
 §291
 §291
 §551
 §554
 §551
 §554