In the amicus brief filed by the Society of Veterinary Hospital Pharmacists (SVHP's), its position is clearly stated:
Regarding the legality of traditional compounding with bulk chemicals, SVHP has adopted a "Position Statement on Compounding," a complete copy of which is available on SVHP's website. See http:svhp.org/position-statement/. That statement recognizes that in many circumstances traditional compounding with bulk chemicals is essential to providing high quality pharmaceutical care for sick animal patients. SVHP supports the ability of veterinary pharmacists, in consultation with veterinarians caring for animal patients in need, to compound medicines from bulk ingredients as follows: If an FDA approved product is unavailable or not appropriate for treatment, compounding with bulk chemicals (APIs) may become necessary and required for proper treatment. The APIs/bulk ingredients used to compound an appropriate product should be of highest possible chemical grade, and the finished product should be compounded from those bulk ingredients using a formula – preferably a USP formula – with evidence-based documentation of potency and stability.
The legal position taken by the United States in this matter, through the Federal Drug Administration (“FDA”), is that any compounding from bulk materials by pharmacists for animals is illegal under the Federal Food Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 301, et seq., and has been since the statute was first enacted in 1938. SVHP respectfully disagrees, and believes that legal position to be incorrect.
In the amicus brief filed by Former FDA officials, they make a very persuasive argument distinguishing between traditional compounding and manufacturing of drugs. Their summary of argument provides:
The Federal Food,
Drug, and Cosmetic Act (“FD&C Act”) did not criminalize traditional
pharmacy compounding, including compounding animal drugs from bulk ingredients.
Instead, the FD&C Act was enacted to regulate drug Case: 11-15350
manufacturing, which is categorically distinct from traditional pharmacy
compounding. Additionally, none of the amendments to the FD&C Act reflect
Congress’ intent to criminalize traditional pharmacy compounding, including
compounding animal drugs from bulk substances.
In asserting that any
compounding of animal drugs from bulk substances is unlawful per se, FDA’s
policy guidance fails to adequately distinguish between traditional pharmacy
compounding of animal drugs and manufacturing of animal drugs. The key difference
between traditional pharmacy compounding of animal drugs on the one hand, and
manufacturing of animal drugs on the other, is that the former is conducted in
response to a prescription order based on a valid Veterinarian-Client-Patient
relationship in the course of professional practice, whereas the latter is not
so circumscribed.
As FDA acknowledges, its policy guidance on animal drug
compounding lacks the force of law. Moreover, in issuing that policy guidance,
FDA failed to comply with its own regulations, which require that, prior to
issuing such guidance, the Agency must provide notice and an opportunity for
interested parties to submit comments.
As we understand the factual record in
this case, the animal drug compounding that Defendants-Appellees conduct is
within the scope of traditional pharmacy practice. The district court’s
decision therefore should be affirmed.
The Former FDA Officials are careful to point out that the "factual record" on appeal did not support manufacturing of drugs. The FDA failed to present this argument in the district court. Frank's in his brief argues that this argument is waived on appeal. Normally, if an issue is not raised in the district court it can be considered waived by the appellate court. If the 11th Circuit wants to avoid the hard issue of what is traditional compounding and what crosses over into manufacturing then it can do so by applying the waiver doctrine.