Wednesday, July 2, 2014

For 2014 FDA has issued six 483s (posted to FDA website; others have been issued but not yet posted) for Compounding Pharmacies in Florida and three in Texas

2014 Pharmacy Inspections and Related Records

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Infusion Options, Inc. Brooklyn, NY FDA 483

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Enforcement Report - Week of July 2, 2014

Enforcement Report - Week of July 2, 2014
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Drugs with Problems July 2, 2014

Drugs Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30 H74477, H74478, Exp. 03/16, H74479, H79766 Exp. 05/16 Class II Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq. Pfizer Us Pharmaceutical Group
Drugs Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40 JKM7188A Class II Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance. Caraco Pharmaceutical Laboratories, Ltd.
Drugs Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02. Lot # 34013122A, Exp 11/15 Class II Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing. Teva Pharmaceuticals USA
Drugs Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC 24208-385-56, UPC 3 24208-385-56 3; Bausch & Lomb Incorporated, Tampa, FL 33637. Lot #: a) 179271, Exp 08/14; b) and c) 146791, 146932, Exp 06/14; 151221, 151922, Exp 09/14; 159102, Exp 02/15; 160912, Exp 03/15; 162422, Exp 04/15; 163641, 05/15; 166592, Exp 07/15; 169273, Exp 09/15; 170482, Exp 10/15; 174882, Exp 12/15; 176932, Exp 01/16; 179272, Exp 02/16; 182772, Exp 05/16; 186722, Exp 07/16; 190182, Exp 09/16; and 191631, Exp 10/16 Class II Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. Bausch & Lomb, Inc.
Drugs Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5. Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15 Class II Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. Bausch & Lomb, Inc.
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FDA Hiring Deputy Center Director for Policy

Deputy Center Director for Policy
...regulatory, scientific, public health and consumer protection agency responsible for ensuring...addition to protecting the health and safety of American consumers. The work of the...programs and activities to ensure the safety, effectiveness, quality and accurate labeling...
Salary:$120,749.00 - $181,500.00 / Per Year
Series & Grade:ES-0301-00/00
Location(s):Silver Spring, Maryland
Open Period:6/9/2014 to 7/9/2014
Announcement Number:FDA-ES-14-CDRH-1135071
Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Position Info:Full Time - Senior Executive Service (SES)
Who May Apply:All groups of qualified individuals
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FDA Hiring Pharmacist

Pharmacist
...products and their applications in order to anticipate possible safety and reporting problems.;Foreign Education: If you are using...evaluating and interpreting contents of submitted professional and consumer labeling information; prepare written analyses and evaluation...
Salary:$89,924.00 - $116,901.00 / Per Year
Series & Grade:GS-0660-13/13
Location(s):Silver Spring, Maryland
Open Period:4/23/2014 to 7/25/2014
Announcement Number:HHS-FDA-CDER-DH-14-1101212
Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Position Info:Full Time - Permanent
Who May Apply:United States Citizens

Pharmacist
...products and their applications in order to anticipate possible safety and reporting problems.;Foreign Education: If you are using...evaluating and interpreting contents of submitted professional and consumer labeling information; preparing written analyses and evaluation...
Salary:$75,621.00 - $98,305.00 / Per Year
Series & Grade:GS-0660-12/12
Location(s):Silver Spring, Maryland
Open Period:4/23/2014 to 7/25/2014
Announcement Number:HHS-FDA-CDER-DH-14-1101222
Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Position Info: Full Time - Permanent
Who May Apply: United States Citizens
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FDA Hiring Regulatory Counsel/Atttorney

Job Title:Regulatory Counsel, GS-301-12
Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Job Announcement Number:FDA-CDER-14-DE-1144742BB

SALARY RANGE:

$75,621.00 to $98,305.00 / Per Year

OPEN PERIOD:

Tuesday, June 24, 2014 to Tuesday, July 8, 2014

SERIES & GRADE:

GS-0301-12

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

Many vacancies in the following location:
Silver Spring, MD View Map

WHO MAY APPLY:

United States Citizens

SECURITY CLEARANCE:

Q - Nonsensitive

SUPERVISORY STATUS:

No

JOB SUMMARY:

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
As a Regulatory Counsel in the Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Office of Management, Immediate Office, User Fee Collections Team, you will provide regulatory advice to others, including the Office Director and Deputy Office Director, Division Directors, Team Leaders, Regulatory Counsels, Pharmacists, and Consumer Safety Officers. 

This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-14-MP-1144747BB under merit promotion procedures.  Please review that announcement to see if you are eligible for consideration under merit promotion procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.
 
This job opportunity announcement may be used to fill additional vacancies.
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Job Openings: FDA Hiring Consumer Safety Officers to Its Work Force in Oklahoma, Texas and Maryland

Consumer Safety Officer, GS-0696-05/07
The salary range listed above is the base salary for GS-05 through GS-07. Respective location salary ranges can be found here . As a Consumer Safety Officer in the Office of Regulatory Affairs (ORA), Office of Regional Food & Drug Director, District Office, you will work with and assist senior Consu
Salary:$27,705.00 - $44,615.00 / Per Year
Series & Grade:GS-0696-05/07
Location(s):
Open Period:7/2/2014 to 7/15/2014
Announcement Number:FDA-ORA-14-DE-1148505BB
Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Position Info:Full Time - Permanent
Who May Apply:United States Citizens

Consumer Safety Officer, GS-0696-11/12/13
...better for all Americans. As a Consumer Safety Officer in the Food and Drug...same geographical locations. The Consumer Safety Officer Specialty areas of need...knowledge directly related to consumer safety officer work. The 30 semester...
Salary:$63,091.00 - $116,901.00 / Per Year
Series & Grade:GS-0696-11/13
Location(s):
Open Period:6/2/2014 to 10/3/2014
Announcement Number:

Consumer Safety Officer, GS-0696-11/12/13
...better for all Americans.;As a Consumer Safety Officer in the Food and Drug...public regarding a range of consumer and biological product safety and availability issues...knowledge directly related to consumer safety officer work. The 30 semester...
Salary:$63,091.00 - $116,901.00 / Per Year
Series & Grade:GS-0696-11/13
Location(s):Silver Spring, Maryland
Open Period:5/23/2014 to 8/20/2014
Announcement Number:FDA-CDER-14-DE-1117949BB
Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Position Info:Full Time - Permanent
Who May Apply:United States Citizens

Save Job   |   More Like This Consumer Safety Officer, GS-0696-11/12/13

...better for all Americans.;As a Consumer Safety Officer, in the Office Medical...Prescription Drug Promotion, Division of Consumer Drug Promotion, Center for Drug...knowledge directly related to consumer safety officer work. (Note: The 30 semester...
Salary:$63,091.00 - $116,901.00 / Per Year
Series & Grade:GS-0696-11/13
Location(s):Silver Spring, Maryland
Open Period:6/25/2014 to 7/9/2014
Announcement Number:FDA-CDER-DE-14-1144611TM
Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Position Info:Full Time - Permanent
Who May Apply:United States Citizens

Save Job   |   More Like This Consumer Safety Officer, GS-0696-05/07/09

...located in Silver Spring, MD. As a Consumer Safety Officer in the Center for Drug...Communication;In order to qualify for Consumer Safety Officer, GS-0696, you must meet...knowledge directly related to consumer safety officer work. The 30 semester...
Salary:$34,415.00 - $67,787.00 / Per Year
Series & Grade:GS-0696-05/09
Location(s):Silver Spring, Maryland
Open Period:6/16/2014 to 7/7/2014
Announcement Number:FDA-CDER-14-DE-1135828DM
Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Position Info:Full Time - Permanent
Who May Apply:United States Citizens

Save Job   |   More Like This Consumer Safety Officer, GS-0696-09/11/12

...the salary range for the respective location. As a Consumer Safety Officer in the Food and Drug Administration (FDA...fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours can include up...
Salary:$41,979.00 - $79,138.00 / Per Year
Series & Grade:GS-0696-09/12
Location(s):
Open Period:7/1/2014 to 7/14/2014
Announcement Number:FDA-ORA-14-DE-1154889BB
Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Position Info:Full Time - Permanent
Who May Apply:United States Citizens

Save Job   |   More Like This Consumer Safety Officer

...communication.;Basic Qualifications for Consumer Safety Officer, GS-0696. A. Degree...knowledge directly related to consumer safety officer work. The 30 semester...AND Minimum Qualifications for Consumer Safety Officer, GS-696-11 I have one...
Salary:$63,091.00 - $116,901.00 / Per Year
Series & Grade:GS-0696-11/13
Location(s):College Park, Maryland
Open Period:6/23/2014 to 7/7/2014
Announcement Number:FDA-CFSAN-14-DE-1044046SW
Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Position Info:Full Time - Permanent
Who May Apply:United States Citizens
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And the FDA List of Compounding Registered Outsourcing Facilities Continues to Grow!!

Compounding Registered Outsourcing Facilities
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A meeting of the European and Mediterranean Horseracing Federation has given its strong backing to the international agreement concerning the use of anabolic steroids in racing.

European backing on steroids

  • Last Updated: July 2 2014, 14:00 BST
read here

 

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US FDA to set more specific GMP regulations for outsourcing facilities

US FDA to set more specific GMP regulations for outsourcing facilities
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New Catamaran Effort to Control Compounds Looks at Safety, Cost | AIS Health

New Catamaran Effort to Control Compounds Looks at Safety, Cost | AIS Health
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FDA Reopening Nomination Process for Compounding Drugs

The FDA is renewing the call for nominations for the list the agency is building of active drug substances that can be used to compound drug products, saying many of the responses to its December effort to build the list were inadequate.
 
more information here
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Gov. Rick Snyder signs pharmacy, consumer protection, local government bills

Wednesday, July 2, 2014

LANSING, Mich. – Gov. Rick Snyder today signed legislation that updates pharmacy safety standards and strengthens oversight.

The bills are a result of a 2012 fungal meningitis outbreak from contaminated steroid injections distributed by the New England Compounding Center in Massachusetts. More than 260 Michigan patients were affected by the outbreak including 22 deaths. The compounding center was only licensed as a compounding facility but acted as a drug manufacturer which contributed to the contamination of the injections.

“These bills will help establish additional safeguards between patients and pharmacists helping ensure Michiganders remain safe and healthy,” Snyder said. “Consumers need and deserve to have confidence in any product they receive, especially medical ones. These changes put patient safety first and are designed to help prevent future tragedies.”

Senate Bill 704, sponsored by state Sen. Joe Hune, provides safeguards for Michigan patients and pharmacy customers. The bill ensures that pharmacies are operating under their scope of service and requires each pharmacy to have a licensed “pharmacist-in-charge” who is responsible for ensuring the facility follows state laws and regulations. It also requires compounding pharmacies to maintain accurate records for all compounded drug sales including the name of the person who prepared and approved the compound. Pharmacies, manufacturers and wholesalers engaged in compounding must submit to at least one state inspection every two years.
SB 904, also sponsored by Hune, establishes felony and penalty provisions for violations of SB 704. Violations that cause personal injury, serious impairment of a bodily function or death can result in four to 15 years’ imprisonment.
“We owe it to the hundreds of Michigan victims of the NECC meningitis tragedy to ensure a disaster of this magnitude does not strike twice,” said Attorney General Bill Schuette.  “This legislation signed by Governor Snyder today will hold every compounding pharmacy responsible for the drugs they distribute and ensure pharmacists always put patient safety first.”

The bills are now Public Acts 280 and 279 of 2014, respectively.
continue to read here
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Indpendent Pharmacy Says CVS trying to grind it into dust, sues

Independent pharmacy says CVS trying to grind it into dust, sues
By on Wed, 07/02/2014 - 9:22am
 
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FDA Releases Five New Compounding Pharmacy Policy Documents

by | July 2, 2014 · 2:45 pm

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Compounding Back in the News as FDA Adds 25 Drugs to the Do Not Compound List

The FDA is proposing to update its list of drug products (previously found in its regulations at 21 CFR 216.24) that have been removed from the market for safety or efficacy and cannot be legally compounded.  It has also revised one product relative to its dosage form that allows compounding under the pharmacy compounding exemption.  Since FDA has approved an ophthalmic form of bromfenac, it has removed the restriction to now permit the compounding in certain situations for this drug product but only for ophthalmic use, whereas this drug was previously excluded for any use by the Rule.
The reason for the old Rule withdrawal and replacement is that, since the list last published on January 4, 2000, new information has come to the Agency’s attention that requires a revised list be published.  The entire 34 page Rule in its prepublication form can be found here
continue to read here
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Express Scripts blocks coverage for compounding pharmacy ingredients; the amount spent by its clients on compounded drugs increase to about $171 million in the first quarter, as compared with $28 million in the same quarter in 2012.

Reporter- St. Louis Business Journal
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Federal judge approves consent decree with New York dietary supplement maker

A federal judge in New York has signed a consent decree for permanent injunction between the United States and Mira Health Products Ltd., a dietary supplement manufacturer located in Farmingdale, New York, and Michael S. Ragno and Michael S. Ragno, Jr.
On July 26, 2013, the FDA issued a warning to consumers not to use or purchase Healthy Life Chemistry By Purity First B-50, a dietary supplement manufactured by Mira. The FDA issued this warning after receiving numerous reports of illness associated with use of the product. An FDA laboratory analysis found that the product contained two drugs that are potentially harmful anabolic steroids—methasterone, a controlled substance, and dimethazine. These ingredients were not listed on the label and should not have been in a dietary supplement because they are illegal drugs and not dietary ingredients.
In August 2013, Mira recalled all dietary supplements manufactured between June 1, 2010 and May 31, 2013.
Mira’s representatives have informed the court that they are out of business and are no longer manufacturing, processing, packing, labeling, holding, or distributing any dietary supplement, any product labeled as such, or any drug.
Under the terms of the consent decree, before Mira can resume operations, the company must first notify the FDA of its intentions at least 60 business days in advance of resuming operations and must retain an independent expert to inspect its operations and certify to the FDA that the necessary corrections have been made.
The company will not be able to resume operations until it receives written notice from the FDA that its operations are compliant with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. Pursuant to the consent decree, the company must, among other things, bring its procedures for manufacturing, packaging and labeling dietary supplements into compliance with federal regulations prior to resuming operations. The company must also recall and destroy, under the FDA’s supervision, all unexpired drugs and dietary supplements manufactured since Aug. 1, 2010.
“By law, dietary supplements must be manufactured according to FDA regulations,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “This consent decree will ensure that this company cannot harm consumers by selling dietary supplements that do not comply with federal manufacturing requirements.”
United States District Court Judge Joseph F. Bianco of the Eastern District of New York entered the consent decree for permanent injunction against Mira Health Products Ltd on July 1, 2014.
Any illnesses or adverse events related to use of these products should be reported to the FDA at https://www.accessdata.fda.gov/scripts/medwatch/ or by calling 800-322-1088
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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Page Last Updated: 07/02/2014  

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