Showing posts with label LLC. Show all posts
Showing posts with label LLC. Show all posts

Monday, February 10, 2014

Dates of Pevious 483s for Professional Compounding Centers of America, LLC

Professional Compounding Centers Of America, LLC

Mar 14, 2012
No 483. 

Professional Compounding Centers Of America, LLC

Jun 11, 2009
No 483. 

Professional Compounding Centers Of America, LLC

Nov 17, 2005
No 483. 

Professional Compounding Centers Of America, LLC

May 15, 2003
 483 issued.
(not in store).

Professional Compounding Centers Of America, LLC

Jun 21, 2000
No 483. 

Professional Compounding Centers Of America, LLC

Jan 25, 2000
 483 issued.
(not in store).


source found here

Wednesday, December 18, 2013

Florida Board of Pharmacy Disciplinary Action Against HVVP RX, LLC

HVVP Rx, LLC, PH 25109 – Seminole, FL
 Case No. 2013-06250 – PCP Fallon/Glass

Count One: Respondent violated Section 465.023(1)(c), F.S. (2012), by violating Rule 64B16-
28.820(3)(a), F.A.C.
Page 10 of 24
Count Two: Respondent violated Section 465.023(1)(c). F.S. (2012), by violating Rule 64B16-
28.830(5).
Count Three: Respondent violated Section 465.023(1)(c), F.S. (2012), by violating Rule 64B16-
27.797(7)(b), F.A.C.

Terms of Settlement Agreement: Respondent shall be present. Respondent shall pay a fine of
$2,500.00. Respondent shall pay costs of $3, 254.88. Respondent shall surrender Special
Parenteral/Enteral modifier. Respondent shall be placed on a probationary period of one year.

Respondent (Pharmacy Manager) was present and sworn in by the court reporter. Respondent was
represented by Daniel G. Musca, Esquire.

Motion: by Dr. Weizer, seconded by Dr. Mikhael, to accept the Settlement Agreement. Motion carried.

Motion: by Dr. Weizer, seconded by Dr. Mesaros, to oppose costs. Motion carried.

Florida Board of Pharmacy Disciplinary Action Against El Vignoble, LLC

El Vignoble, LLC, PH 23858. Lauderdale Lakes, FL
Case No. 2013-04482 – PCP Weizer/Meshad

Count One: Respondent violated Section 465.023(1)(c), F.S. (2012), by violating Rule 64B16-102(4),
F.A.C., which requires that the prescription department of each pharmacy be provided with adequate
sanitation to insure the prescription department is operating under clean, sanitary, uncrowded, and healthy
conditions.
Count Two: Respondent violated Section 465.023(1)(c), F.S. (2012), by violating Rule 64B16-28.110,
F.A.C., which requires expired medications be removed from the shelves.
Count Three: Respondent violated Section 465.023(1)(c), F.S. (2012), by violating Section 893.07(1)(b),
F.S. (2012), which requires dispensers of controlled substances to maintain, on a current basis, a complete
and accurate record of each substance manufactured, received, sold, delivered, or otherwise disposed of
by him or her.
Count Four: Respondent violated Section 465.023(1)(c), F.S. (2012), by violating Section 499.005(2),
F.S. (2012), by the adulteration or misbranding of any drug, device, or cosmetic.

Terms of Settlement Agreement: Respondent shall be present. Respondent shall pay a fine of
$2,500.00 within 30 days. Respondent shall pay costs not over $1,087.03. Respondent shall be placed on
probation for a period of one year with terms to include: semi-annual inspections, development of a
corrective action plan, and a mandate to appear in front of the Board within the last 3 months of
probationary period.

Sinikiwe Chiwara was present on behalf of El Vignoble, LLC and sworn in by the court reporter.
Respondent was represented by Brian Kahan, Esquire.

Motion: by Dr. Mikhael, seconded by Mr. Philip, to accept the Settlement Agreement with the oral
amendment to extend payment deadline to one year. Motion carried.

quoted from minutes of December 3-4, 2013 Meeting

Wednesday, October 30, 2013

[C’s Discount Pharmacy, Inc. et al. v. Louisiana CVS Pharmacy, LLC, No. 13-2989 Section “C”(3), E.D. La., 2013 U.S. Dist. LEXIS 140939]--

Here are the facts:  Plaintiffs in Louisiana sold two pharmacies to CVS. Part of the  agreement purchase and sales agreement included a non-competition clause prohibiting sellers from competing within 10 miles for a period of 5 years.  CVS paid a stated $1.1 million for the benefits of the non-competition agreement. The agree also included a provision for a $1 million “holdback” to assure payment of the seller’s indemnification obligations. The holdback was to be paid on March 30, 2013. CVS refused, however, to pay the holdback, claiming that plaintiffs had, contrary to the non-competition agreement, competed by directing former customers of theirs to pharmacies other than CVS. Plaintiff sued to demolish the agreement.

Be sure and read this case or the summary if you are a member of ASPL and receive their e-news.

Tuesday, September 17, 2013

Another Reason Congress Needs to Be Very Clear About What Any New Federal Compounding Legislation Covers: New Company--PharmaCo., LLC. form-alliance of compounding pharmacies and drs.; New Questions Raised.


PharmaCo's website indicates that it 

represents a nationwide collective of compounding pharmacies that provide fulfillment services to physicians participating in topical pain modalities.
We do business in all 50 states through our Pharmacy Partnership Program, jointly delivering a compelling suite of services for physicians (Practice Support Program - hyperlink this to the description) that minimizes practice overhead while maximizing patient satisfaction.

quoted from PharmaCo website.  Would the draft Senate or House Legislation cover a LLC that includes an "alliance" of compounding pharmacies?  Is this a way for compounding pharmacies to avoid the draft federal legislation applying to them?  How many compounding pharmacies are already a part of this alliance?  Who is a part of this alliance? Does Congress need specific provisions to deal with these types of groups?   Will we see more of these partnership/alliances forming?  Will a similar alliance form with regard to compounding veterinary pharmacies?

Friday, August 9, 2013

Texas Board of Pharmacy Previously Disciplined Specialty Compounding, LLC, Cedar Park, TX and Its Pharmacist Raymond Lawrence Solano

In an agreed order with both the pharmacist Raymond Lawrence Solano and Specialty Compounding, LLC, Cedar Park, TX, the Texas Board of Pharmacy fined both $5000.00 for Solano dispensing prescription drugs in a state in which he had no licence.  The pharmacy was also required to develop a policy and procedure for operating in another state with a valid licence.

source found here

Specialty Compounding, LLC, Cedar Park, TX FDA 483

Saturday, May 4, 2013

California Board of Pharmacy Issues Cease and Desist Order to Southern California Compounding Pharmacy, LLC


Southern California Compounding Pharmacy, LLC, LSC 99510, Administrative Case AC 4671
San Diego, CA
Cease and Desist Order for any and all non-sterile to sterile compounding.  Effective April 19, 2013.

Monday, February 18, 2013

Envision Telepharmacy's Recently Patented Process Lowers Sterile Compounding Costs

Wed Feb 13, 2013 2:25pm EST

For best results when printing this announcement, please click on the link
below:

http://pdf.reuters.com/pdfnews/pdfnews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20130213:nPnDA59854

Lets technicians and pharmacists work together without pharmacists gowning-up
and entering the restricted area or technicians interrupting their work to wait
for, or seek out, their supervising pharmacists
ALPINE, Texas,  Feb. 13, 2013  /PRNewswire/ -- Envision Telepharmacy, LLC, a
pioneer in remote pharmacy technology and services, announced today that the US
Patent and Trademark Office has issued US Patent  8,374,887 covering the remote
supervision and verification of sterile compounding by non-pharmacists in
hospital and health care system settings. The patented method covers images or
videos of the compounding process at appropriate stages, review by
remotely-located pharmacists, and an indication of pharmacist verification.

To reduce the cost of high-risk compounding in restricted areas, Envision
incorporated this patent into its  Pharm-Q In the Hood  (ITH) product.   Pharm-Q
ITH  lets technicians and pharmacists work together without pharmacists
gowning-up and entering the restricted area or technicians interrupting their
work to wait for, or seek out, their supervising pharmacists.

"The recent 2012 public health crisis tied to the New England Compounding Center
(NECC) began to highlight systemic problems in sterile product compounding, and
has underscored the importance of the both the methods of preparation used and
accountability for process," said inventor and Envision CEO  Emily Alexander,
PharmD., BCPS.   

"Increasing use of outsourced sterile products has, in part, been an attempt to
manage drug shortages and provide patient-driven health care.  The need for
sterile compounded products will continue to increase as pharmaceutical
companies continue to abandon drug production in response to declining margins.
With increased oversight by state and federal agencies, the cost of producing
sterile products will only rise.  

"This makes for the perfect storm, driving all healthcare institutions to
re-visit the economics and risks associated with compounded injectable
preparations.  While safeguarding patients, our proprietary technology can help
take the bite out of a costly but indispensable workflow element - pharmacist
oversight and verification.  Our method allows best utilization of pharmacists
and pharmacy technicians by allowing them to focus on the parts of the process
that most need their specialized training and skills.  It also provides better
process documentation, an area where increased scrutiny from regulators and
accrediting agencies is already underway."

The recently assigned patent was licensed exclusively to Envision Telepharmacy,
becoming part of Envision's ever-expanding technology portfolio. Since its
inception nearly 10 years ago, Envision has made significant investments in
technologies that generate real returns to hospitals and health care
institutions while meeting increasingly complex medication preparation
requirements.

About Envision Telepharmacy, LLC
Envision Telepharmacy was established in 2004 to provide better ways to extend
pharmacy services for hospitals and health care systems in need. We are a
pioneer in developing tools, services and systems  that provide electronic
supervision and remote order processing through high-bandwidth, standards-based
web technology, still imaging, and high resolution video.  Enabling and
realizing safe, quality patient care and pharmacist access through the use of
compliant and cost-effective telepharmacy solutions is our mission.

For more information about Envision Telepharmacy, LLC visit  www.envision-rx.com
 or contact CEO  Emily Alexander, PharmD, BCPS at (432) 897-0754 ext 105 or
email envision(at)envision-rx(dot)com.

SOURCE  Envision Telepharmacy, LLC

Thursday, January 24, 2013

Warning Letter Issued to Kuiper Dairy, LLC in Hico, Texas

Kuiper Dairy, LLC 12/19/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 
 
December 19, 2012
 
2013-DAL-WL-022
 
WARNING LETTER
 
UPS Overnight
                                                                                                     
 
Clemens Kuiper, Owner
Kuiper Dairy, LLC.
1865 PR 1233
Hico, Texas 76457
 
Dear Mr. Kuiper:
 
On October 30, 2012 and November 1-2, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1865 PR 1233, Hico, Texas. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov
 
We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
 
Specifically, our investigation revealed that on or about July 23, 2012, you sold a dairy cow, identified with ear tag(b)(4) for slaughter as food. On or about July 23, 2012, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 1.16 parts per million (ppm) of penicillin in the kidney. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.510 (21 C.F.R. 556.510). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
 
Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
 
We also found that you adulterated the new animal drug (b)(4) (penicillin G procaine) NADA (b)(4). Specifically, our investigation revealed that you did not use (b)(4) as directed by its approved labeling. Use of this drug in this manner is an extralabel use. 21 C.F.R. 530.3(a).
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. 
 
Our investigation found that you administered (b)(4) to a dairy cow with ear tag (b)(4) without following the withdrawal period or intended use as stated in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of (b)(4)resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
 
The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
 
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction. 
 
FDA acknowledges the written response we received following our investigation. A letter postmarked November 7, 2012, was received addressing the observations made during the investigation we conducted at your location in Hico, Texas. Although your letter indicates that your firm has taken steps to address our observations, your response did not contain enough detail for us to evaluate. The corrections your firm has implemented at both sites will be evaluated and verified during our next inspection.
 
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
 
Your written response should be sent to Jeff R. Wooley, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Jeff R. Wooley at 214-253-5251.
 
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
District Director
Dallas District
 
Enclosure(s)
 
cc:   
FSIS District Office 40
Attn: Dr. Jennifer Beasley-McKean, DM
1100 Commerce Street, Room 516
Dallas, TX 75242-0598
 
Texas Department of State Health Services
1100 W. 49th Street
Austin, TX 78756


Wednesday, September 5, 2012

FDA Warning Letter to DPT Lakewood, LLC


On August 27, 2012, the FDA issued a warning letter to DPT Lakewood, LLC, located in New Jersey.  The beginning of the letter states:

During our February 15 to March 7, 2012 inspection of your pharmaceutical manufacturing facility located at 1200 Paco Way, Lakewood , NJ, an investigator from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product, Santyl Ointment, to be adulterated within the meaning of section 501 (a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351 (a)(2)(8)], in that the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
We have reviewed your firm 's response of March 22, 2012, and note that it lacks sufficient corrective actions.
To read the remainder of this warning letter, click here.