FDA Seminar Materials on Importation of API Requirements

The material below may be found here.
Importation of Active Pharmaceutical Ingredients (APIs) Requirements
7-16-08 FDA NYK-DO API Seminar Presentation Notes (Tab A)
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TAB CONTENTS
A. GENERAL IMPORTATION: Definitions (Page 1)
B. REGISTRATION AND LISTING: FRN (Page 2)
C. API EXEMPTIONS (Page 4)
D. MISBRANDING: Labeling Requirements & Exemptions (Page 6)
E. MARKETING: Requirements & Useful Information (Page 6)
OTC, Pharmacy Compounding, Pre-Submission Batches, and Rx
F. DATABASE: Drug Master Files (DMFS)/Establishment Evaluation
System (EES) (Page 8)
G. PRE-LAUNCH ACTIVITIES IMPORTATION REQUEST (PLAIR)
(Page 9)
H. CONTACTS (Page 9)
Importation of Active Pharmaceutical Ingredients (APIs) Requirements
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A. DEFINITIONS:
1. “Drug” [FD&C Act Section 201(g)(1)]:
• Articles intended to diagnose, cure, mitigate, treat or prevent disease in man
or other animals
• Articles (other than food) intended to affect the structure or any function of
the body of man or other animals
• Articles intended for use as a component of a drug
2. "New" drug [FD&C Act Section 201 (p) & 505]:
• "any drug.... the composition of which is such that such drug is not generally
recognized, among experts qualified by scientific training and experience....,
as safe and effective for use under the conditions prescribed, recommended
or suggested in the labeling."
• A “new drug” must be covered by an approved new drug application
(NDA/ANDA) to be marketed in the U.S. or by an investigational new drug
application (IND)
• Applies to both Rx and OTC drugs
3. Over-the-counter drug products (OTC):
• All other drugs that can be used safely without medical supervision
Example: Medications for fever such as aspirin and acetaminophen,
preparations for the common cold or allergies, antacids, and some
first aid antibiotics
4. Prescription (Rx) drug products (Rx) [FD&C Act Section 503(b)(1)]:
• These drugs cannot be used safely without medical supervision
Example: Injectable drugs or drugs to treat serious conditions like heart
disease, cancer, or fertility problems
Importation of Active Pharmaceutical Ingredients (APIs) Requirements
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5. Active Pharmaceutical Ingredient (API) a.k.a. bulk drug substance
[21 CFR 207.3]
• "any substance that is represented for use in a drug and that, when used in
the manufacturing, processing, or packaging of a drug, becomes an active
ingredient or a finished dosage form of the drug“
• "term does not include intermediates used in the synthesis of such
substance"
6. Adequate Directions for Use [21 CFR 201.5]: “directions under which a
layman can use the drug safely….”
B. REGISTRATION & LISTING:
1. Requirements for Foreign Establishments:
• FFDCA Section 510(i) [21 U.S.C. 360]
• 21 CFR 207.40
• FFDCA Section 502(o) [21 U.S.C. 352]
• FFDCA Section 801(o) [21 U.S.C. 381]
2. Foreign firms that manufacture, prepare, propagate, compound, or process
a drug imported or offered for import into the U.S. are required to…
a. Register name and place of business
b. List all drugs imported or offered for import into the U.S.
c. Designate a U.S. Agent
- Each foreign drug establishment shall designate only one United States
agent
- Must be physically located in the U.S.
- Point of contact between FDA and foreign firm on all drug registration &
listing matters and requirements
- Letter of designation must:
o Be prepared on the foreign firm's letterhead
o Signed by authorizing official of the firm
o Contain: Name of the firm's designated U.S. Agent, Address,
Telephone/ fax numbers, and E-mail address
Importation of Active Pharmaceutical Ingredients (APIs) Requirements
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3. Registration must be renewed annually
4. Registration required before any application is approved
5. Listing information must be updated:
a. Every June and December or
b. Discretion of the registrant or
c. When any change occurs
6. National Drug Code Number (NDC #):
a. Assigned to each listed product
b. Identifies manufacturer/distributor, drug, and trade package size/type
c. FDA requests but does not required to appear on the product label or
labeling:
- If the NDC # appears on the label it must comply with
21 CFR 207.35 (b)(3)
7. Does not indicate FDA’s approval of a firm or its products
8. The Bioterrorism Act of 2002:
Requires foreign drug establishments whose drugs are imported into the U.S. to
submit certain information with the annual registration (This is in addition to
the regular registration requirements):
- Each importer/consignee of each drug in the U.S. known to the manufacturer
at time of registration
- Each person who imports or offers to import the manufacturer’s drugs
- The name and contact information of U.S. Agent
9. Non-listed products are misbranded [502(o)] & in violation of 801(a)(3)
10. Firms that are not in compliance with 510(i) are in violation of 801(o)
11. Listing Requirements – Exemptions:
a. Inactive ingredients
b. Intermediates (non-API)
c. Drug products not for importation into the U.S.
d. Drugs imported or offered for import under an Investigational New Drug
Application (IND) [21 CFR 312]
e. Components of drugs imported under 801(d)(3) - Import for Export (IFE)
Importation of Active Pharmaceutical Ingredients (APIs) Requirements
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12. Information:
a. FDA Forms: www.psc.gov/forms
b. NDC Directory: www.fda.gov
c. Guidance Annual Registration:
www.fda.gov/cder/drls/registration_listing.htm
d. Annual Registration Status: www.fda.gov/cder/dfars/default.htm
e. Registration & Listing contact number: 301-210-2840
f. Draft Guidance: E-Registration & Listing: FRN Vol. 73, No. 134, 7/11/08,
Page 39964
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Providing Regulatory
Submissions in Electronic Format--Drug Establishment Registration and
Drug Listing.'' This draft guidance document establishes a Pilot Program for
industry to voluntarily submit drug establishment registration and drug
listing information in an electronic format that FDA can process, review, and
archive. The document provides guidance on what required and FDArecommended
information related to drug establishment registration and
drug listing to submit and on how to electronically prepare and submit the
information to FDA.
C. API EXEMPTIONS:
1. 21 CFR 201.122(a):
a. API is intended for use in a product approved in a NDA, ANDA, or
supplement
b. API is manufactured by the supplier approved in the new drug application
c. Prescription (Rx) and over-the-counter (OTC) drugs covered by an approved
application
d. Labeling (Must):
• “Caution: for manufacturing, processing, or repacking” &
• “Rx only”- when most dosage forms in which the API may be used are
subject to prescription [503(b)(1)]
e. Useful Information:
• API product name and NDC number
• Name and address of the API manufacturer
• Number of approved NDA/ANDA or supplement
• Finished dosage drug product name and NDC number
Importation of Active Pharmaceutical Ingredients (APIs) Requirements
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2. 21 CFR 201.122(b):
a. API is intended for use in a product subject to an IND (for clinical use)
b. Must be covered by an active IND
c. Must be going to person(s) authorized in the IND
d. Labeling (Must):
• “Caution: for manufacturing, processing, or repacking in the preparation
of a new drug or new animal drug limited by federal law to
investigational use”
e. Useful Information:
• IND number
• Sponsor’s name
• Name of the product
3. 21 CFR 201.122(c):
a. API is intended for use in a product subject to a pending NDA or ANDA or
supplement
b. API is manufactured by the supplier included in the pending NDA, ANDA,
or supplement.
c. Applies to prescription (Rx) and over-the-counter (OTC) drugs
d. Labeling (Must):
• “Caution: for manufacturing, processing, or repacking” &
• “Rx only”- when most dosage forms in which the API may be used are
subject to prescription [503(b)(1)]
e. Useful Information:
• API product name and NDC number
• Name and address of the API manufacturer
• Number of pending NDA/ANDA or supplement
• Finished dosage drug product name and NDC number (if applicable)
• Written commitment that products manufactured with the API will not be
introduced in commercial distribution until they are approved
4. 21 CFR 201.125:
a. API is intended for use in teaching, law enforcement, research, and analysis
b. Includes both APIs and finished drug products
c. Cannot be used in human research
d. API product name and NDC number
e. Name and address of the API manufacturer
f. Name and address of U.S. Consignee
g. Written commitment that the quantity offered for import is reasonable for
the contemplated research, teaching, analysis, etc.
Importation of Active Pharmaceutical Ingredients (APIs) Requirements
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5. 21 CFR 312.160:
a. API is intended for investigational (IND) use in laboratory research animals
or in-vitro testing
b. To conduct R&D work prior to the submission of an IND
c. Product cannot be used in humans
d. Must comply with all the requirements under 21 CFR 312.160
e. Includes both APIs and finished drug products
f. Labeling (Must):
• “Caution: Contains a new drug for investigational use only in laboratory
research animals, or for tests in-vitro. Not for use in humans”
g. Useful Information:
• API product name
• Name and address of API manufacturer
• API label content demonstrating compliance with 21 CFR 312.160
D. MISBRANDING - Adequate Directions for Use [502(f)(1) & 21 CFR
201.5]: “directions under which a layman can use the drug safely”
1. All drugs, including APIs, must bear “adequate directions for use” or meet one
of the exemptions. If not, then misbranded [502(F)(1)].
2. Only OTC finished drug products can meet this requirement. All other drugs
must meet one of the exemptions
E. MARKETING – REQUIREMENTS & USEFUL INFORMATION:
1. OTC pending and final monograph drugs:
a. Labeling (Must):
• “Caution: for manufacturing, processing, or repacking”
b. Useful Information:
• Name and NDC # of product to be manufactured with the API
• A statement justifying why an approval is not required for the finished
drug product
• API label content demonstrating compliance with 21 CFR 201.122
Importation of Active Pharmaceutical Ingredients (APIs) Requirements
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2. Pharmacy Compounding
a. Labeling (Must):
• “For Prescription Compounding”
• “Rx only”
b. Useful Information:
• API is a component of an FDA approved drug
• API meets official compendial requirements when applicable
Example: Certificate of Analysis
• Drug has not been withdrawn or removed from the U.S. market for public
health reasons (list in CPG 460.200)
• API product name and NDC #
• Name of API manufacturer and registration number
• A written commitment that the API will be sold and used solely for
pharmacy compounding by a state licensed pharmacy or federal facility
• A written commitment that the drug has not been withdrawn or removed
from the U.S. market for public health reasons
3. Pre-Submission Batches: (Batches used to conduct the studies necessary to
generate data required to submit an application or supplement
Example: Bioequivalence, bioavailability, and stability batches)
a. Useful Information:
• API product name and NDC #
• Name and address of the API manufacturer
• Name and address of U.S. consignee
• Product must be labeled as per 21 CFR 201.122
• For supplements - may include number of NDA/ANDA to be
supplemented and NDC # of finished product
b. Written commitment that product manufactured with API will not be
introduced in commercial distribution until approved
c. Explanation that API is intended to generate data to submit an application/
supplement
Example: Bioequivalence and/or bioavailability batches
Importation of Active Pharmaceutical Ingredients (APIs) Requirements
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4. Prescription (Rx) drugs not currently subject to application requirements:
a. Labeling (Must):
• “Caution: For manufacturing, processing, or repacking”
• “Rx only”
b. Useful Information:
• Name and NDC # of product to be manufactured with the API
• A statement justifying why an approval is not required for the finished
drug product
• API label content demonstrating compliance with 21 CFR 201.122
F. DATABASES:
1. Drug Master Files (DMFs):
a. Contain API chemistry and manufacturing control information
b. Are submitted to FDA voluntarily by the API manufacturer
c. NDA/ANDA sponsors may elect to refer to a an API DMF in their
application
d. Are not approved by FDA
e. They are reviewed by FDA in reference to a submission and are judged to be
either adequate or inadequate with regard to that submission
f. May be referenced in multiple applications
g. May be associated with both approved and unapproved applications
h. A DMF number is not sufficient to show that the API supplier is approved in
an application

Criminalization of Medication Errors; Mistakes by Pharmacists

The following article appears at http://www.uspharmacist.com/content/c/16572/

Jesse C. Vivian, BS Pharm, JD

Professor, Department of Pharmacy Practice
College of Pharmacy and Health Sciences
Wayne State University
Detroit, Michigan

11/19/2009

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.

Facts of the Case

On February 24, 2006, while working at the Rainbow Babies and Children’s Hospital in Cleveland, Ohio, licensed pharmacist Eric Cropp received a prescription for a chemotherapy solution of Eposin (etoposide phosphate) that was supposed to be mixed in an IV bag of normal saline containing 0.9%

USA: Doctor jailed over misbranded drugs

USA: Doctor jailed over misbranded drugs

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.

Corporate HGH Smuggler Gets Fine

From the Steroids Bodybuilding Peptides and SARMS Blog:


Corporate HGH Smuggler Gets Tiny Fine

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.

C.R. Pharmacy Services d/b/a Fifth Avenue Pharmacy and Fifth Avenue Compounding Litigation in Iowa; Doctor Sued

Iowa court denies new trial in pharmacy lawsuit

DAVID PITT, Associated PressCopyright 2012 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

DAVID PITT, Associated Press

Updated 07:13 p.m., Friday, June 29, 2012inShare

Page 1 of 1

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.

Read more: http://www.mysanantonio.com/news/article/Iowa-court-denies-new-trial-in-pharmacy-lawsuit-3674230.php#ixzz1zHhIPTy1

To review the Iowa Supreme Court decision click here.

Code of Federal Regulation for Incurin (Estriol) tablet

Oral Dosage Form New Animal Drugs; Estriol

A Rule by the Food and Drug Administration on 12/16/2011

Publication Date:

Friday, December 16, 2011

Agencies:

Department of Health and Human Services

Food and Drug Administration

Dates:

This rule is effective December 16, 2011.

Effective Date:

12/16/2011

Entry Type:

Rule

Document Citation:

76 FR 78149

Page:

78149 -78150 (2 pages)

CFR:

21 CFR 520

Agency/Docket Number:

Docket No. FDA-2011-N-0003

Document Number:

2011-32214

Shorter URL:

https://federalregister.gov/a/2011-32214

Action

Final Rule.

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of estriol tablets for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.Show citation box

Table of Contents

• DATES:
• FOR FURTHER INFORMATION CONTACT:
• SUPPLEMENTARY INFORMATION:
• List of Subjects in 21 CFR Part 520

DATES: Back to Top

This rule is effective December 16, 2011.

FOR FURTHER INFORMATION CONTACT: Back to Top

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.

SUPPLEMENTARY INFORMATION: Back to Top

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.

The Agency has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.Show citation box

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.

List of Subjects in 21 CFR Part 520 Back to Top

Animal drugs.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS Back to Top

1. The authority citation for 21 CFR part 520 continues to read as follows:

Authority: Back to Top

21 U.S.C. 360b.Show citation box

2. Add § 520.852 to read as follows:

§ 520.852 Estriol.

(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.

Dated: December 9, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

[FR Doc. 2011-32214 Filed 12-15-11; 8:45 am]

Canadian Operator of Internet Drug Outlet Indicted for Distribution of Fake Drugs to US Consumers

From the National Association of Boards of Pharmacy website:
June 27, 2012 01:15 PM

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.

In California One of Common Errors is Incorrect NDC codes for Compounded Drugs

License Renewal

Processing Delayed

Atlantic Associates, Inc., the CURES data collection

vendor, has identified to the Board the four most often

occurring reporting errors. Pharmacies are entering:

1. Invalid NDC numbers;

2. Incorrect NDC codes for compounded

formulations: They should be entering the NDC

code for the main active ingredient and identifying

the prescription as a compounded drug; and

3. Invalid prescriber DEA numbers.

4. Pharmacies are also failing to enter the Method of

Payment: Cash, Medicaid/Medi-Cal, Medicare,

Commercial Insurance, Major Medical, or

Workman’s Compensation.

To ensure proper data collection, those who are

responsible for making CURES entries must make every

effort to enter valid and accurate information.

List found here.

Beware of drug transfer dealers that are not California-licensed Wholesalers

The following warning appeared in the March 2012 California Board of Pharmacy Newsletter:

Frequently, pharmacies find themselves with near-expired
drugs, partially full containers of drugs, and drugs that are
rarely dispensed and unlikely to be dispensed in the near
future. The pharmacies may return such drugs to the wholesaler
they purchased them from or to a reverse distributor, and less
frequently to the manufacturer itself. Sometimes a pharmacy may
be partially reimbursed for the cost of the drugs or charged a fee
for destroying the drugs.
Some California pharmacies, seeking to reduce their
inventory of such drugs have become involved with out-of-state
companies who solicit membership in their online business,
which allows members to post their requests to buy, sell, bid on,
or trade unwanted drugs to other members. One such company
assures that becoming a member and using their services will
increase the pharmacies’ profits by 50 percent. However, all
the parties to such transactions may be violating

Rule Regarding Patient-Centered Labels for Prescription Drugs Now in Effect in California

The new rule in California provides:


1707.5. Patient-Centered Labels for Prescription Drug
Containers; Requirements
(a) Labels on drug containers dispensed to patients in California
shall conform to the following format:
(1) Each of the following items shall be clustered into one
area of the label that comprises at least 50 percent of the
label. Each item shall be printed in at least a 10-point
sans serif typeface or, if requested by the consumer, at
least a 12-pooint typeface, and listed in the following
order:
(A) Name of the patient
(B) Name of the drug and strength of the drug. For the
purposes of this section, “name of the drug” means
either the manufacturer’s trade name of the drug, or
the generic name and the name of the manufacturer.
(C) The directions for the use of the drug.
(D) The condition or purpose for which the drug was
prescribed if the condition or purpose is indicated
on the prescription.
(2) For added emphasis, the label shall also highlight in
bold typeface or color, or use blank space to set off the
items listed in subdivision (a)(1).
(3) The remaining required elements for the label specified
in section 4076 of the Business and Professions Code,
as well as any other items of information appearing on
the label or the container, shall be printed so as not to
interfere with the legibility or emphasis of the primary
elements specified in paragraph (1) of subdivision (a).
These additional elements may appear in any style, font,
and size typeface.

To read remainder of new rule, click here.

Alabama Board of Pharmacy to Discuss Compounding Rules at July Meeting

OPEN WORK SESSION AGENDA:

Wednesday, July 18^th at 7:30 AM

• Topics to include the following:
• Call center rules for Act 2012-213 (Walgreens)

Thursday, July 19^th at 8:00 AM

(will likely last all day)

• Complete call center rules for Act 2012-213 if needed
• Compounding Rules

Agenda can be found here.

What Happened to James Belden, DVM, in the Franck's case

Pursuant to the June 7, 2011, Florida Board of Veterinary Medicine the following occurred:

BOARD OF VETERINARY MEDICINE

General Business Meeting

June 7, 2011

Page 1

MINUTES

Board of Veterinary Medicine

General Business Meeting

Holiday Inn Resort – The Castle

8629 International Drive

Orlando, FL 32819

June 7, 2011

James Belden, DVM: Case number 2009-021573

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.

Utah Rules Relating to Compounding

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.

Texas State Board of Pharmacy Proposed Amendments

SUBCHAPTER G. SERVICES PROVIDED BY PHARMACIES
22 TAC §291.131, §291.133
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.
§291.131.Pharmacies Compounding Non-Sterile Preparations.
(a) - (c) (No change.)
(d) Operational Standards.
(1) - (6) (No change.)
(7) Drugs, components, and materials used in non-sterile compounding.
(A) - (H) (No change.)
(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.
(8) - (10) (No change.)
(e) - (f) (No change.)
(g) Recall Procedures.
(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.
(3) If the pharmacy identifies a potential or confirmed harm to a patient, the pharmacist-in-charge shall ensure that:
(A) each practitioner, facility, and/or pharmacy to which the preparation was distributed is notified, in writing, of the recall;
(B) each patient to whom the preparation was dispensed is notified, in writing, of the recall;
(C) if the preparation is prepared as a batch, the board is notified of the recall, in writing;
(D) if the preparation is distributed for office use, the Texas Department of State Health Services, Drugs and Medical Devices Group, is notified of the recall, in writing;
(E) the preparation is quarantined; and
(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.
[(1) The pharmacy shall have written procedure for the recall of any compounded non-sterile preparations provided to a patient, to a practitioner for office use, or to a pharmacy for administration. The recall procedures shall require:]
[(A) notification to each practitioner, facility, and/or pharmacy to which the preparation was distributed;]
[(B) notification to each patient to whom the preparation was dispensed;]
[(C) quarantine of the product if there is a suspicion of harm to a patient; and]
[(D) a recall if there is probable or confirmed harm to a patient.]
[(2) If the pharmacy identifies a suspicion of, probable, or confirmed harm to a patient, the pharmacy shall immediately notify and provide information as required by the board to the following:]
[(A) the Texas Department of State Health Services, Drugs and Medical Devices Group, if the preparation is distributed for office use; and]
[(B) the board.]
(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.
§291.133.Pharmacies Compounding Sterile Preparations.
(a) - (c) (No change.)
(d) Operational Standards.
(1) - (9) (No change.)
(10) Drugs, components, and materials used in sterile compounding.
(A) - (G) (No change.)
(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.
(11) - (13) (No change.)
(e) - (f) (No change.)

Summary of FDA bill passed by Congress

Summary of FDA bill passed by Congress

Associated Press – Tue, Jun 26, 2012

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.

Here's a look at some of the key changes the bill would bring:

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.

Amendment with Respect to Misbranding Contained in Senate Bill 3187

The final version of Senate Bill 3187 as passed and headed ot the President's desk can be read by clicking here. 

One amendment provided for in the bill is an amendment to the misbranding provision as follows:

SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING.

Section 502 (21 U.S.C. 352) is amended by adding at the end the following:

‘(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.’.

From American Society of Health-System Pharmacists

News Capsule

Drug Shortages Bill Headed to White House

6/27/2012

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. 

“This is a very important achievement for ASHP,“ said chief executive officer Paul W. Abramowitz, Pharm.D., FASHP. “We are gratified that the determined efforts of our members and our staff resulted in this resounding victory for patients.”

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. 

President Obama is expected to sign the bill in the coming days. 

Pharmacies Receive Suspicious Offers of Wholesale Drugs; Importance of Following FDA Guidelines to Protect Patients Stressed

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.