FDA's Final Strategic Plan: Key Initiatives Relating to Compounding

The FDA's Final Strategic Plan for the Foods and Veterinary Program, which was announced on April 23, 2012, provides the following initiatives related to compounding:

7.2 – Reduce availability of substandard and illegally marketed animal drugs.
The FVM Program is concerned about the number of unapproved animal drug products that are being sold and marketed to animal owners and veterinarians. To reduce the risk of harm from substandard and illegally marketed animal drugs, the program will identify new regulatory frameworks and enforcement strategies to combat this growing area of concern.

Key Initiatives
7.2.1: Develop risk‐based frameworks that assure quality and safety for animal drug products that are currently being marketed without FDA approval.
7.2.2: Develop and implement an enforcement strategy that addresses the illegal compounding of new animal drugs and removes unsafe, ineffective or copycat animal drugs from the market.

FDA Announces Final Strategic Plan for the Foods and Veterinary Medicine Program

April 23, 2012
The U.S. Food and Drug Administration (FDA) announces the release of the final Strategic Plan for the Foods and Veterinary Medicine Program (FVM) for 2012-2016. The plan addresses the responsibilities of the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine while including activities supported by the Office of Regulatory Affairs. The plan illustrates the breadth and complexity of the program’s work and identifies priority initiatives. It outlines seven strategic program goals, each encompassing its own key objectives, as well as nearly 100 specific initiatives aimed at achieving goals and objectives.
The draft Strategic Plan was published on September 30, 2011, with a thirty-day comment period. The FDA carefully reviewed and considered all submitted comments before issuing this final Strategic Plan.

Click here to view the final plan.

FDA Website with Index to Major Warning Letters

FDA's website http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/

PharmacyCompounding/default.htm contains an index with links to major compliance 

actions and major warning letters issued to compounder through March 2011.  Anyone

considering doing business with a compounder should check to see if warning letter or 

action has been taken by the FDA or the state pharmacy boards.    The index for the FDA

website  appears as follows:

Pharmacy Compounding

Pharmacy Compounding News

• FDA Statement on Makena¹ (3/30/2011)
• News for Pharmacy Compounders in Regards to Possible Melamine Contamination of Pharmaceutical Components² (9/28/2009)
• Medical Center Pharmacy v. Mukasey³ (8/14/2008)

Significant Compliance Actions

• 2010
  • FDA News: FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedure⁴ (4/7/2010)
    • Pure Med Spa⁵
    • All about you medispa⁶
    • Idinhealth⁷
    • Spa 35⁸
    • Monarch medispa⁹
    • Medical Cosmetic¹⁰
    • Zipmed and Mesoone¹¹
  • Warning Letters
    • VanderVeer Center, 11/18/10, Center for Drug Evaluation and Research (CDER)¹²
    • Med Prep Consulting, 7/9/10, New Jersey District Office¹³
    • J & F International Inc., dba Alexandria Medical Arts Pharmacy & Compounding Laboratory, 4/9/2010, Baltimore District Office¹⁴
      
      
• 2009
  • Warning Letters
    • Hopewell Pharmacy and Compounding Center, 9/28/2009, Center for Drug Evaluation and Research (CDER)¹⁵
• 2008
  • FDA News: FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs¹⁶ (1/9/2008)
    • Panorama Compounding Pharmacy¹⁷
    • Saint John's Medical Plaza Pharmacy¹⁸
    • Murray Avenue Apothecary¹⁹
    • Village Compounding Pharmacy²⁰
    • Pharmacy Compounding Specialties²¹
    • Reed's Compounding Pharmacy²²
    • Pacifica Pharmacy²³
  • Warning Letters
    • Civic Center Pharmacy, 12/16/2008, Los Angeles District Office ²⁴
    • Steven's Pharmacy, 11/12/2008, Los Angeles District Office²⁵
    • Aerosol Science Laboratories Inc., 10/29/2008, Center for Drug Evaluation and Research (CDER)²⁶
    • Newman Inc., (dba Medi-Stat), 6/24/2008, New Orleans District Office²⁷
    • Farmacia La Salud Inc., 3/26/2008 San Juan District Office²⁸
    • Bellevue Pharmacy Solutions, 1/14/2008, Kansas City District Office²⁹
    • American Hormones, Inc., 1/10/2008, New York District Office ³⁰
• 2007
  • Warning Letters
    • Med-South Pharmacy Inc., 9/28/2007, New Orleans District Office³¹
    • PharMEDium Services, LLC, 4/13/2007, Dallas District Office³²
    • ComputeRx/Broncho-Dose, Ltd. 3/21/2007, New England District Office³³
    • Kalchem International, Inc., 1/8/2007, Dallas District Office ³⁴
• 2006
  • FDA News: FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams³⁵ (12/5/2006)
    • Triangle Compounding Pharmacy³⁶
    • University Pharmacy³⁷
    • Custom Scripts Pharmacy³⁸
    • Hal’s Compounding Pharmacy, Inc.³⁹
    • New England Compounding Center⁴⁰
  • FDA News: FDA Warns Three Pharmacies To Stop Mass-Producing Unapproved Inhalation Drugs⁴¹ (8/10/2006)
    • Rotech Healthcare, Inc.⁴²
    • CCS Medical⁴³
  • Warning Letters
    • Spoonamore Drug Co., Inc., 12/1/2006, Cincinnati District Office ⁴⁴
    • Health Dimensions, Inc., 11/27/2006, Detroit District Office ⁴⁵
    • Pharmacy Creations, 10/31/2006, New Jersey District Office⁴⁶
    • Wedgewood Village Pharmacy, 10/31/2006, New Jersey District Office⁴⁷
    • B. Braun Medical Inc., 3/15/2006, Philadelphia District Office⁴⁸
    • Southern Meds Joint Venture, LLC, 2/15/2006, New Orleans District Office⁴⁹
• 2004
  • FDA News: FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production⁵⁰
  • Warning Letters
    • Axium Healthcare Pharmacy⁵¹
    • Drugs Are Us (dba Hopewell Pharmacy)⁵²
    • Peoples Pharmacy, Inc.⁵³
    • Spectrum Chemicals and Laboratory Products⁵⁴

Pharmacy Compounding Advisory Committee Materials⁵⁵

Compounding Surveys

• Report: 2006 Limited FDA Survey of Compounded Drug Products⁵⁶
• Report: Limited FDA Survey of Compounded Drug Products⁵⁷ (2/13/2003)

DOJ/FDA reply to Franck's and Amici Waiver Argument

In addressing the waiver argument raised by Franck's and amici, DOJ/FDA contends:

The government's brief cites numerous instances in the record where it argued and documented that the factual basis of this action for injunctive relief is that Franck's animal drug compounding activities exceed the bounds of traditional pharmacy compounding and are indicative of large-scale drug manufacturing, as described in CPG 608.400.

DOJ/FDA also explains that this case involves a question of law--not the specific facts--of the case.  It  states,  "To be sure, the fundamental issue in this case is a question of law, the resolution of which depends on analysis of the FDCA, not on any specific facts."  Nonetheless, DOJ/FDA argues it is both necessary and logical to discuss FDA's enforcement policy and application of that policy to the facts on which the complaint for injunctive relief was based.  DOJ/FDA argues it has not waived the argument because it has not belatedly raised a new theory.  More specifically, its brief contains the following argument:

Contrary to Franck's claims, the government has not belatedly raised an "alternative theory" of its case – that compounded animal drugs are unlawful only when prepared in an operation resembling manufacturing. There is but one theory of this case: New animal drugs compounded by pharmacies are not exempt from the FDCA and never were, and they are accordingly subject to FDA's enforcement authority. However, FDA recognizes that compounded animal drugs can serve beneficial public health purposes. Thus, pursuant to its consistent, longstanding policy, FDA undertakes enforcement action against compounding pharmacies only when the scope and nature of their activities "raise the kinds of concerns normally associated with a drug manufacturer and result in significant [FDCA] violations." CPG 608.400, Doc. 17-2, Ex. A at 4. Because Franck's animal drug compounding operations raise such concerns, the government brought this action to enjoin Franck's further violations of the Act. That has been the government's position throughout this litigation. 

Ultimately, DOJ/FDA contends that government counsel's previous comments at the district court level are not sufficient to show waiver:

Citing excerpts from government counsel's responses to questions during district court oral argument, Franck's Lab contends further that FDA has waived certain other arguments, e.g., the relevance of AMDUCA and other FDCA provisions to the statutory interpretation question at issue. As FDA's opening brief notes (at 41 & n.15), government counsel's comments do not support Franck's waiver claim. Moreover, this Court has held that "waivers and concessions made in appellate oral arguments need to be unambiguous before they are allowed to change the outcome of an appeal," and such comments should be considered in the context of the party's briefs and entire presentation. Crowe v. Coleman, 113 F.3d 1536, 1542 (1997). See also Moose Lodge v. Irvis, 407 U.S. 163, 170, 92 S. Ct. 1965, 1970 (1972) ("We are loath to attach conclusive weight to the relatively spontaneous responses of counsel to equally spontaneous questioning from the Court during oral argument."). That same principle should apply to counsel's comments during district court arguments.Thus, considering the government's complaint, arguments in support of its motions for a preliminary injunction and summary judgment, declarations, and other evidence, snippets of government counsel's argument in district court cannot reasonably be construed as concessions or waivers of any legal arguments. Cf. Savoury v. U.S. Attorney General, 449 F.3d 1307, 1318-19 (11th Cir. 2006) (even if estoppel applies to government, willfulness and negligence, inter alia, must be shown).