August 10, 2000

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD  20852

Re:    FDA Concept Paper: Drug Products That Present
       Demonstrable Difficulties for Compounding Because of
       Reasons of Safety or Effectiveness.
     
Dear Sir/Madam:

For reasons stated below, the Office of Advocacy
respectfully requests that the comment deadline for the
above-referenced FDA Concept Paper be extended by at least
90 days from the time all documents contained in the
bibliography and referenced in the Concept Paper have been
placed in the docket.

The Office of Advocacy of the U.S. Small Business
Administration (SBA) was established by Congress pursuant to
Pub. L. No. 94-305 to represent the views of small business
before federal agencies and Congress.  One of the primary
functions of the office is to measure the costs and other
effects of government regulation on small businesses and
make proposals for eliminating excessive or unnecessary
regulations of small businesses.  The Chief Counsel of
Advocacy is required by section 612(a) of the Regulatory
Flexibility Act (RFA)(1) to monitor agency compliance with
the RFA and to report annually to Congress and the President
on such compliance.  The Chief Counsel of Advocacy is also
authorized to appear as amicus curiae in any action brought
in court to review a rule.  In any such action, the Chief
Counsel is authorized to present views with respect to
compliance with the RFA, the adequacy of the rulemaking
record with respect to small entities, and the effect of the
rule on small entities.(2)

Industry groups that will be affected by the recommendations
stemming from this Concept Paper have expressed concern that
the present 45-day comment period (which expires August 15,
2000) is insufficient to evaluate the impact of the
document.  The 45-day period is particularly inadequate
since many of the research studies and other documents
referenced in the Concept Paper have not been placed in the
docket, and therefore, are not available for public
inspection or comment.  The Office of Advocacy is advancing
this request by the industry because pharmacies that
compound drug products are primarily small businesses, and
because the policies adopted as a result of the Concept
Paper will have broad and serious implications for these
small businesses.
Without a doubt, the Concept Paper will serve as the basis
of future regulations that will severely curtail the ability
of compounding pharmacists to compound and sell certain drug
products.  Specifically, FDA is attempting to identify, list
and define drug products that present "demonstrable
difficulties for compounding that reasonably demonstrate an
adverse effect on the safety or effectiveness of that drug
product."  FDA wants to include both specific drug products
and categories of products that are grouped by relevant
factors (e.g., specific drug delivery system) in the list of
drug products that are demonstrably difficult to compound.
Among the products FDA wants to include in their definition
of "demonstrably difficult" are sterile products, products
with transdermal delivery systems (skin patches), metered
dose inhaler products, and dry powder inhaler products.  The
data and research supporting FDA's recommendations on the
referenced products have not been made available for public
comment.

There is well-established case law that points to the
importance and necessity of a complete administrative record
on which the interested public can comment.(3) Courts have
ruled that when agencies fail to place a large percentage of
their supporting evidence on file, they have acted in an
arbitrary and capricious manner.(4)

The Office of Advocacy also has concerns about the level of
outreach used by the agency to apprise the industry and
interested persons about the Concept Paper and the agency's
request for comments.  The Concept Paper was published on
FDA's website rather than in the Federal Register.  While
publication on FDA's website is one form of outreach, it may
limit the number of comments submitted because some
concerned entities are accustomed to searching the Federal
Register for significant policy and regulatory actions.
Moreover, FDA's outreach efforts may be subject to the
judicial review provisions of the RFA once a rule is
promulgated.(5) In light of the scope, importance and
controversy surrounding the issues contained in the Concept
Paper, FDA should have initiated a broader outreach effort.

Given that there are serious issues about the incomplete
docket, the potential impact on the industry and the limited
outreach, the Office of Advocacy requests that a 90-day
comment period be allowed to give the industry adequate time
to prepare meaningful comments.  The 90-day period should
begin only after all supporting documentation has been added
to the docket.  Thank you for your consideration of this
important matter.  Please do not hesitate to contact our
office if you have any questions, 202-205-6533 or 202-205-
6945.

Sincerely,

Jere W. Glover
Chief Counsel for Advocacy

Shawne Carter McGibbon
Asst. Chief Counsel for Advocacy

ENDNOTES

1.  5 U.S.C.  601 et seq. as amended by the Small Business
Regulatory Enforcement Fairness Act of 1996, Pub. L. No. 104-
121, 110 Stat. 857.
2.  Id. at  612
3.  See, e.g., Connecticut Light & Power Co. v. Nuclear
Regulatory Commission, 673 F.2d 525, 530 (D.C. Cir. 1982)
("the purpose of the comment period is to allow interested
members of the public to communicate information, concerns,
and criticisms to the agency.  . In order to allow for
useful criticism, it is especially important for the agency
to identify and make available technical studies and data
that it has employed in reaching the decisions to propose
particular rules.  To allow an agency to play hunt the
peanut with technical information, hiding or disguising the
information that it employs, is to condone a practice in
which the agency treats what should be a genuine interchange
as mere bureaucratic sport.  An agency commits serious
procedural error when it fails to reveal portions of the
technical basis for a proposed rule in time to allow for
meaningful commentary").
4.  See, Hanover Potato Products, Inc. v. Sullivan, No. 1:CV-
90-0746, slip op. at 4-5 (June 21, 1990), quoted in Hanover
Potato Products, Inc. v. Sullivan, No. 90-5738, 1991 U.S.
App. LEXIS 4423 (3rd Cir. App. March 20, 1991).
5.  See  5 U.S.C.   609(a)  and 611.