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.