|
Code of Federal Regulations
|
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.3]
[Page 38-39]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart A--General Provisions
Sec. 510.3 Definitions and interpretations.
As used in this part:
(a) The term act means the Federal Food, Drug, and Cosmetic Act, as
amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C.
321-392).
(b) Department means the Department of Health and Human Services.
(c) Secretary means the Secretary of Health and Human Services.
(d) Commissioner means the Commissioner of Food and Drugs.
(e) Person means individuals, partnerships, corporations, and
associations.
(f) The definitions and interpretations of terms contained in
section 201 of the act shall be applicable to such terms when used in
the regulations in this part.
(g) The term new animal drug means any drug intended for use for
animals other than man, including any drug intended for use in animal
feed but not including such animal feed:
(1) The composition of which is such that such drug is not generally
recognized, among experts qualified by scientific training and
experience to evaluate the safety and effectiveness of animal drugs, as
safe and effective for use under the conditions prescribed, recommended,
or suggested in the labeling thereof; except that such a drug not so
recognized shall not be deemed to be a new animal drug if at any time
prior to June 25, 1938, it was subject to the Food and Drug Act of June
30, 1906, as amended, and if at such time its labeling contained the
same representations concerning the conditions of its use; or
(2) The composition of which is such that such drug, as a result of
investigations to determine its safety and effectiveness for use under
such conditions, has become so recognized but which has not, otherwise
than in such investigations, been used to a material extent or for a
material time under such conditions.
(h) The term animal feed means an article which is intended for use
for food for animals other than man and which is intended for use as a
substantial source of nutrients in the diet of the animal, and is not
limited to a mixture intended to be the sole ration of the animal.
(i) The newness of an animal drug, including a new animal drug
intended for use in or on animal feed, may arise by reason of: (1) The
newness for its intended drug use of any substance of which the drug is
comprised, in whole or in part, whether it be an active substance or a
menstruum, excipient, carrier, coating, or other component; (2) the
newness for its intended drug use of a combination of two or more
substances, none of which is itself a new animal drug; (3) the newness
for its intended drug use of the proportion of a substance in a
combination, even though such combination containing such substance in
other proportion is not a new animal drug; (4) the newness for its
intended drug use in a different species of animal; (5) the newness of
its intended drug use in diagnosing, curing, mitigating, treating, or
preventing a disease, or to affect a structure or function of the animal
body, even though such drug is not a new animal drug when used in
another disease or to affect another structure or function of the body;
or (6) the newness of a dosage, or method or duration of administration
or application, or any other condition of use prescribed, recommended,
or suggested in the labeling of such drug, even though such drug or
animal feed containing such drug when used in another dosage, or another
method or duration of administration or application, or different
condition, is not a new animal drug.
(j) Animals used only for laboratory research and laboratory
research animals mean individual animals or groups of animals intended
for use and used solely for laboratory research purposes, regardless of
species, and does not include animals intended to be used for any food
purposes or animals intended to be kept as livestock.
[[Page 39]]
(k) The term sponsor means the person responsible for an
investigation of a new animal drug, including responsibility for
compliance with applicable provisions of the act and regulations. The
sponsor may be an individual, partnership, corporation, or Government
agency or may be a manufacturer, scientific institution, or an
investigator regularly and lawfully engaged in the investigation of new
animal drugs.
[40 FR 13807, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 54
FR 22741, May 26, 1989; 64 FR 69190, Dec. 10, 1999]
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.4]
[Page 39]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart A--General Provisions
Sec. 510.4 Biologics; products subject to license control.
An animal drug produced and distributed in full conformance with the
animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21
U.S.C. 151 et seq.) and any regulations issued thereunder shall not be
deemed to be subject to section 512 of the Federal Food, Drug, and
Cosmetic Act.
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.7]
[Page 39]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart A--General Provisions
Sec. 510.7 Consignees of new animal drugs for use in the manufacture of animal feed.
(a) A new animal drug intended for use in the manufacture of animal
feed shall be deemed to be unsafe unless at the time of its removal from
the establishment of a manufacturer, packer, or distributor of such
drug, such manufacturer, packer, or distributor has an unrevoked written
statement from the consignee of such drug, or a notice from the
Secretary, to the effect that with respect to the use of such drug in
animal feed the consignee:
(1) Holds a license issued under Sec. 515.20 of this chapter; or
(2) Will, if the consignee is not the user of the drug, ship such
drug only to a holder of an approved application under Sec. 515.10 of
this chapter.
(b) The requirements of paragraph (a) of this section do not apply:
(1) Where such drugs are intended for export and/or
(2) When the use of such drug in the manufacture of a finished feed
has been exempted from the requirements of section 512(m) of the act
under the conditions specified by regulations published in part 558 of
this chapter.
[40 FR 13807, Mar. 27, 1975, as amended at 64 FR 63203, Nov. 19, 1999]
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.105]
[Page 39]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart B--Specific Administrative Rulings and Decisions
Sec. 510.105 Labeling of drugs for use in milk-producing animals.
(a) Part 526 of this chapter provides for new animal drugs intended
for intramammary use in animals and includes conditions of use intended
to prevent the contamination of milk from the use of such drugs.
(b) Preparations containing antibiotics and other potent drugs
labeled with directions for use in milk-producing animals will be
misbranded under section 502(f)(2) of the act unless their labeling
bears appropriate warnings and directions for use to avoid adulteration
of milk under section 402(a)(2)(c)(ii) of the act.
(c) It is the position of the Food and Drug Administration that the
labeling for such preparations should bear a clear warning that either:
(1) The article should not be administered to animals producing
milk, since to do so would result in contamination of the milk; or
(2) The label should bear the following statement: ``Warning: Milk
that has been taken from animals during treatment and for ____ hours
after the latest treatment must not be used for food'', the blank being
filled in with the figure that the manufacturer has determined by
appropriate investigation is needed to insure that the milk will not
carry violative residues resulting from use of the preparation. If the
use of the preparation as recommended does not result in contamination
of the milk, neither of the above warning statements is required.
[40 FR 13807, Mar. 27, 1975, as amended at 63 FR 32980, June 17, 1998;
64 FR 51241, Sept. 22, 1999]
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.106]
[Page 39-40]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart B--Specific Administrative Rulings and Decisions
Sec. 510.106 Labeling of antibiotic and antibiotic-containing drugs intended for use in milk-producing animals.
Whenever the labeling of an antibiotic drug included in the
regulations in this chapter suggests or recommends its use in milk-
producing animals, the label of such drugs shall bear either the
statement ``Warning: Not for use in animals producing milk, since this
use
[[Page 40]]
will result in contamination of the milk'' or the statement ``Warning:
Milk that has been taken from animals during treatment and for __
__hours after the latest treatment must not be used for food'', the
blank being filled in with the figure that the Commissioner has
authorized the manufacturer of the drug to use. The Commissioner shall
determine what such figures shall be from information submitted by the
manufacturer and which the Commissioner considers is adequate to prove
that period of time after the latest treatment that the milk from
treated animals will contain no violative residues from use of the
preparation. If the Commissioner determines from the information
submitted that the use of the antibiotic drug as recommended does not
result in its appearance in the milk, the Commissioner may exempt the
drug from bearing either of the above warning statements.
[63 FR 32980, June 17, 1998]
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.110]
[Page 40-41]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart B--Specific Administrative Rulings and Decisions
Sec. 510.110 Antibiotics used in food-producing animals.
(a) The Food and Drug Administration in the interest of fulfilling
its responsibilities with regard to protection of the public health has
requested an evaluation of the public health aspects of the use of
antibiotics in veterinary medical and nonmedical uses. There is
particular concern with regard to the potential hazards associated with
the extensive use of antibiotics administered to food-producing animals.
Accordingly, an ad hoc committee on the Veterinary Medical and
Nonmedical Uses of Antibiotics was established by the Food and Drug
Administration to study and advise the Commissioner of Food and Drugs on
the uses of antibiotics in veterinary medicine and for various
nonmedical purposes as such uses may affect the enforcement of the
Federal Food, Drug, and Cosmetic Act with respect to their safety and
effectiveness.
(b) Based upon an evaluation of the conclusions of said Committee
and other relevant material, Sec. 510.112 was published in the Federal
Register of August 23, 1966 (31 FR 11141), asking sponsors of drugs
containing any antibiotic intended for use in food-producing animals to
submit data to establish whether such antibiotic and its metabolites are
present as residues in edible tissues, milk, and eggs from treated
animals. The data on the residues of antibiotics in milk from
intramammary infusion preparations were requested within 60 days and the
data on all other products were requested within 180 days following the
date of publication of Sec. 510.112 in the Federal Register.
(c) An evaluation of the data now available shows that use of many
antibiotic preparations cause residues in edible products of treated
animals for varying and, in some cases, for long periods of time
following the last administration. Because of the accumulation of new
information with regard to the development of resistance of bacteria to
antibiotics, the ability of bacteria to transfer this resistance, and
the development of sensitivity to antibiotics in humans, unauthorized
and unsafe residues of antibiotics cannot be permitted in food obtained
from treated animals.
(d) Based on evaluation of information available, including the
conclusions of the aforementioned ad hoc Committee, the Commissioner
concludes that antibiotic preparations intended for use in food-
producing animals, other than topical and ophthalmic preparations, are
not generally recognized among qualified experts as having been shown to
be safe for their intended use(s) within the meaning of section 201(s)
of the Federal Food, Drug, and Cosmetic Act.
(e) Therefore, all exemptions from the provisions of section 409 of
the act for use of antibiotics in food-producing animals based on
sanctions or approvals granted prior to enactment of the Food Additives
Amendment of 1958 (Pub. L. 85-929; 72 Stat. 1784) will be revoked and
the uses which are concluded to be safe will be covered by food additive
regulations. On those products for which there are inadequate residue
data, actions will be initiated to withdraw approval of new-drug
applications under the provisions of section 505 of the act. Antibiotic
preparations, other than those for topical and ophthalmic application in
food-producing animals, which are not covered by food additive
regulations will be subject to regulatory action
[[Page 41]]
within 180 days after publication of the forthcoming revocation order.
(f) Because of the variation in the period of time that antibiotic
residues may remain in edible products from treated animals, all
injectable, intramammary infusion, intrauterine, and oral preparations,
including medicated premixes intended for use in food-producing animals,
are deemed to be new drugs as well as food additives.
[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989;
64 FR 403, Jan. 5, 1999]
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.112]
[Page 41]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart B--Specific Administrative Rulings and Decisions
Sec. 510.112 Antibiotics used in veterinary medicine and for nonmedical purposes; required data.
(a) An ad hoc committee, Committee on the Veterinary Medical and
Nonmedical Uses of Antibiotics, was formed by the Food and Drug
Administration to study, and advise the Commissioner on, the use of
antibiotics in veterinary medicine and for various nonmedical purposes
as such uses may affect the enforcement of the Federal Food, Drug, and
Cosmetic Act with respect to the safety and effectiveness of such
substances. A copy of the report may be obtained from the Food and Drug
Administration, Office of Public Affairs, Room 15-05, Parklawn Building,
5600 Fishers Lane, Rockville, MD 20857.
(b) On the basis of the report of the Committee and other
information, sponsors of drugs containing any antibiotic intended for
use in food-producing animals shall submit data for determining whether
or not such antibiotics and their metabolites are present as residues in
edible tissues, milk, and eggs from treated animals; however, in the
case of a drug for which such data have already been submitted and for
which a regulation has been promulgated under section 409 of the act,
only such data as has been accumulated since the issuance of the
regulation need be submitted.
(c) The required data shall be submitted within 180 days of the date
of publication of this section in the Federal Register; except that in
the case of data on intramammary infusion preparations the data shall be
submitted within 60 days of such publication. Data demonstrating the
absence in milk of residues of intramammary infusion preparations when
used as directed in their labeling are needed within the 60-day period
because of the importance of milk in the human diet.
(d) Regulatory proceedings including revocation of prior sanctions,
or actions to suspend or amend new drug or antibiotic approvals granted
prior to passage of the Food Additives Amendment of 1958 (72 Stat.
1784), may be initiated with regard to the continued marketing of any
antibiotic preparation on which the required information is not
submitted within the period of time prescribed by paragraph (c) of this
section.
(e) Questions relating to the acceptability of proposed research
protocols and assay methods for determining the amount of antibiotic
residues in food should be directed to the Director, Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855.
[40 FR 13807, Mar. 27, 1975, as amended at 46 FR 8460, Jan. 27, 1981; 54
FR 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992]
Subpart C [Reserved]
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.300]
[Page 41-43]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart D--Records and Reports
Sec. 510.300 Records and reports concerning experience with new animal drugs for which an approved application is in effect.
(a) On receiving notification that an application submitted pursuant
to Sec. 514.1 of this chapter for a new animal drug is approved, the
applicant shall establish and maintain such records and make such
reports as are specified in this section to facilitate a determination
as to whether there may be grounds for suspending or withdrawing
approval of the application or whether any applicable regulation should
be amended or repealed. The applicant shall maintain adequately
organized and indexed files containing full reports of information
pertinent to the safety or effectiveness of the new animal drug that
have not previously been submitted as part of his application for the
drug and which are received or otherwise obtained by him from any
source, as follows:
[[Page 42]]
(1) Unpublished reports of clinical or other animal experience,
studies, investigations, and tests conducted by the applicant or
reported to him by any person involving the new animal drug that is the
subject of the application or any related drugs. An adequate summary and
bibliography of reports in the scientific literature would ordinarily
suffice. (The application must identify at the time of each report
submission, each drug he considers related to the subject drug.)
(2) Experience, investigations, studies, or tests involving the
chemical or physical properties or any other properties of the new
animal drug, such as its behavior or properties in relation to
microorganisms, including both the effects of the drug on microorganisms
and the effect of microorganisms on the drug.
(3) For information required by this section, adequate
identification of its source, when known, including the name and post
office address of the person who furnishes such information.
(4) Copies of all mailing pieces and other labeling, and, if it is a
prescription new animal drug or a veterinary feed directive drug, all
advertising other than that contained in the application used in
promoting the drug, and copies of the currently used package labeling
that gives full information for use of the drug whether or not such
labeling is contained in the application.
(5) Information concerning the quantity of the new animal drug
distributed in a manner and form that facilitates estimates of the
incidence of any adverse effects reported to be associated with the use
of the drug. This does not require disclosure of financial, pricing, or
sales data.
(6) Information concerning any previously unreported changes from
the conditions described in an application conforming to the conditions
of Sec. 514.8(a)(5) of this chapter.
(b) The applicant shall submit to the Food and Drug Administration
copies of the records and reports described in paragraph (a) of this
section, except routine assay and control records, appropriately
identified with the new animal drug application(s) to which they relate,
as follows:
(1) Immediately upon receipt by the applicant, complete records or
reports covering information of the following kinds:
(i) Information concerning a mixup in the new animal drug or its
labeling with another article.
(ii) Information concerning any bacteriological or significant
physical or other change or deterioration in the new animal drug, or any
failure of one or more distributed batches of the drug to meet the
specifications established for it in the new animal drug application.
(2) As soon as possible, and in any event within 15 working days of
its receipt by the applicant, complete records of reports concerning any
information of the following kinds:
(i) Information concerning any unexpected side effects, injury,
toxicity, or sensitivity reaction or any unexpected incidence or
severity thereof associated with clinical use, studies, investigations,
or tests, whether or not determined to be attributable to the new animal
drug, except that this requirement shall not apply to the submission of
information described in a written communication to the applicant from
the Food and Drug Administration as types of information that may be
submitted at other designated intervals. Unexpected as used in this
subdivision refers to conditions or developments not previously
submitted as part of the new animal drug application, or conditions and
developments occurring at a rate higher than that shown by information
previously submitted as part of the application.
(ii) Information concerning any unusual failure of the new animal
drug to exhibit its expected pharmacological activities.
(3) When mailing pieces, any other labeling, and advertising are
devised for promotion of the new animal drug, specimens shall be
submitted at the time of initial dissemination of such labeling and at
the time of initial publication of any advertisement for a prescription
drug. Mailing pieces and labeling designed to contain samples of a drug
shall be complete except for the omission of the drug.
(4) All the kinds of information described in paragraph (a) of this
section,
[[Page 43]]
other than that submitted under the provisions of paragraphs (b) (1),
(2), and (3) of this section, shall be submitted as follows unless
otherwise ordered in a written communication from the Commissioner:
(i) At intervals within 6 months beginning with the date of approval
of the new animal drug application during the first year following such
date, and at yearly intervals thereafter.
(ii) Whenever an applicant is required to submit reports under the
provisions of paragraph (b)(4)(i) of this section with respect to more
than one approved application for preparations containing the same new
animal drug so that the same item(s) of information is (are) required to
be reported for more than one application, he may elect to submit as a
part of the report for one such application all the information common
to such applications in lieu of reporting separately and repetitively on
each. The applicant shall state when this is done and identify all the
new animal drug applications for which the reports are submitted.
(iii) The submitted copies of records and reports shall include all
the required information that was received or otherwise obtained by the
applicant during the designated intervals.
(5) On written order of the Commissioner, within the time stated in
such order or agreed to by the applicant and the Commissioner, any
designated records or reports containing the kinds of information
described in this section shall be submitted.
(c) The applicant shall, upon request of any properly authorized
officer or employee of the Department at reasonable times, permit such
officers to have access to and copy and verify any records and reports
established and maintained under the provisions of this section.
(d) If the Food and Drug Administration finds that the applicant has
failed to establish a system for maintaining required records or has
repeatedly or deliberately failed to maintain such records or to make
required reports in accordance with the provisions of this section, or
that the applicant has refused to permit access to or copying of, or
verification of such records or reports, the Commissioner shall give the
applicant notice and opportunity for a hearing on the question of
whether to withdraw the approval of the application, as provided in
Sec. 514.200 of this chapter.
(e) Upon written request of the applicant stating reasonable grounds
therefor, the Commissioner will make available any information in
possession of the Food and Drug Administration of the kinds the
applicant is required to maintain under the provisions of this section,
except information readily available to the applicant from other sources
or information which the Commissioner concludes is confidential.
(f) The applicant required to establish and maintain records and
make reports required by this section includes any person whose name
appears on the labeling of the drug as its manufacturer, packer, or
distributor under an approval or who is engaged in the manufacturing,
processing, packing, or labeling of the drug under an approval of the
new animal drug application or any supplement to it; however, to avoid
unnecessary duplication in the submission of reports, any such
applicant's obligation to submit a report may be met by its submission
on his behalf, designated as such, by another person responsible for
reporting.
[40 FR 13807, Mar. 27, 1975, as amended at 65 FR 76928, Dec. 8, 2000]
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.301]
[Page 43-44]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart D--Records and Reports
Sec. 510.301 Records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect.
Records and reports of clinical and other experience with the new
animal drug will be maintained and reported, appropriately identified
with the new animal drug application(s) to which they relate, to the
Center for Veterinary Medicine in duplicate in accordance with the
following:
(a) Immediately upon receipt by the applicant, complete records or
reports covering information of the following kinds:
(1) Information concerning any mixup in the new animal drug or its
labeling with another article.
[[Page 44]]
(2) Information concerning any bacteriological, or any significant
chemical, physical, or other change or deterioration in the drug, or any
failure of one or more distributed batches of the drug to meet the
specifications established for it in the new animal drug application.
(b) As soon as possible, and in any event within 15 working days of
its receipt by the applicant, complete records or reports concerning any
information of the following kinds:
(1) Information concerning any unexpected side effect, injury,
toxicity, or sensitivity reaction or any unexpected incidence or
severity thereof associated with clinical uses, studies, investigations,
or tests, whether or not determined to be attributable to the new animal
drug, except that this requirement shall not apply to the submission of
information described in a written communication to the applicant from
the Food and Drug Administration as types of information that may be
submitted at other designated intervals. Unexpected as used in this
paragraph refers to conditions or developments not previously submitted
as part of the new animal drug application or not encountered during
clinical trials of the drug, or conditions or developments occurring at
a rate higher than shown by information previously submitted as part of
the new animal drug application or at a rate higher than encountered
during such clinical trials.
(2) Information concerning any unusual failure of the new animal
drug to exhibit its expected pharmacological activity.
[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989]
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.302]
[Page 44]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart D--Records and Reports
Sec. 510.302 Reporting forms.
(a) The information described in Sec. 510.300, except that described
in paragraphs (b) (1) and (2) of that section, shall be submitted
appropriately identified with the new animal drug application(s) to
which they relate in duplicate on Form FD-2301 ``Transmittal of Periodic
Reports and Promotional Material for New Animal Drugs.''
(b) All adverse experiences with new animal drugs as described in
Sec. 510.300(b)(2) or Sec. 510.301(b) whether or not related to a
required periodic report submitted on a Form FD-2301, shall be reported
on Form FD-1932 ``Adverse Drug Reaction'' (except as provided in
paragraph (c) of this section). Reports of adverse drug experiences may
be submitted initially in the form of a written communication, but any
such communication shall be followed promptly (but not necessarily
within the prescribed 15 working days) by a completed Form FD-1932. A
separate ``Adverse Drug Reaction'' form should be submitted for each
patient where feasible.
(c) In lieu of Form FD-1932 the holder of an approved new animal
drug application may submit:
(1) A computerized report if the information contained therein and
the sequence in which it is presented are equivalent to that required by
Form FD-1932 and the report is submitted in duplicate. Such reports will
require initial approval by the Food and Drug Administration prior to
use; and
(2) Copies of reports of reactions appearing in the published
scientific literature may be submitted.
(d) Forms FD-1932 and FD-2301, with instructions for their use, may
be obtained from the Food and Drug Administration, Department of Health
and Human Services, Center for Veterinary Medicine, 7500 Standish Pl.,
Rockville, MD 20855.
[40 FR 13807, Mar. 27, 1975, as amended at 41 FR 35844, Aug. 25, 1976;
54 FR 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992]
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.305]
[Page 44]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart D--Records and Reports
Sec. 510.305 Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs.
Each applicant shall maintain in a single accessible location:
(a) A copy of the approved medicated feed mill license (Form FDA
3448) on the premises of the manufacturing establishment; and
(b) Approved labeling for each Type B and/or Type C feed being
manufactured on the premises of the manufacturing establishment or the
facility where the feed labels are generated.
[64 FR 63203, Nov. 19, 1999]
[[Page 45]]
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.410]
[Page 45]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart E--Requirements for Specific New Animal Drugs
Sec. 510.410 Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling requirements.
(a) The Food and Drug Administration has received reports of side
effects associated with the oral, injectable, and ophthalmic use of
corticosteroid animal drugs. The use of these drugs administered orally
or by injection has resulted in premature parturition when administered
during the last trimester of pregnancy. Premature parturition may be
followed by dystocia, fetal death, retained placenta, and metritis.
Additionally, corticosteroids used in dogs, rabbits, and rodents during
pregnancy have produced cleft palate in offspring. Use in dogs has
resulted in other congenital anomalies, including deformed forelegs,
phocomelia, and anasarca. Drugs subject to this section are required to
carry the veterinary prescription legend and are subject to the labeling
requirements of Sec. 201.105 of this chapter.
(b) In view of these potentially serious side effects, the Food and
Drug Administration has concluded that the labeling on or within
packaged corticosteroid-containing preparations intended for animal use
shall bear conspicuously the following warning statement:
Warning: Clinical and experimental data have demonstrated that
corticosteroids administered orally or by injection to animals may
induce the first stage of parturition if used during the last trimester
of pregnancy and may precipitate premature parturition followed by
dystocia, fetal death, retained placenta, and metritis.
Additionally, corticosteroids administered to dogs, rabbits, and
rodents during pregnancy have resulted in cleft palate in offspring.
Corticosteroids administered to dogs during pregnancy have also resulted
in other congenital anomalies, including deformed forelegs, phocomelia,
and anasarca.
[49 FR 48535, Dec. 13, 1984]
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.440]
[Page 45]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart E--Requirements for Specific New Animal Drugs
Sec. 510.440 Injectable iron preparations.
There has been an increasing interest in the use of injectable iron
compounds for the prevention or treatment of iron-deficiency anemia in
animals. Although some such preparations have been shown to be safe,
such articles are regarded as new animal drugs within the meaning of the
Federal Food, Drug, and Cosmetic Act. Accordingly, an approved new
animal drug application is required prior to the marketing of such
preparations within the jurisdiction of the act. In addition to the need
for demonstrating the safety of such articles, the labeling of such
preparations should not only recommend appropriate dosages of iron but
also declare the amount (in milligrams) of available iron (Fe) per
milliliter of the subject product.
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.455]
[Page 45-46]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart E--Requirements for Specific New Animal Drugs
Sec. 510.455 New animal drug requirements regarding free-choice administration in feeds.
(a) For the purpose of this section, free-choice administration of
animal drugs in feeds involves feeds that are placed in feeding or
grazing areas and are not intended to be consumed fully at a single
feeding or to constitute the entire diet of the animal. Such methods of
administering drugs include, but are not limited to, medicated blocks
(agglomerated feed compressed or rendered into a solid mass and cohesive
enough to hold its form), mineral mixes, and liquid feed tank
supplements (``lick tank'' supplements) containing one or more animal
drugs. The manufacture of medicated free-choice feeds is subject to the
current good manufacturing practice regulations for medicated feeds.
(b) The Food and Drug Administration has concluded that there are
questions about the safety and effectiveness of drugs when administered
in free-choice feeds. Therefore, such methods of administration cause
the drugs so administered to be new animal drugs, for which approved new
animal drug applications (NADA's) are required. (See Sec. 510.3(i)). In
addition, the exemption from the requirement of an approved medicated
feed application provided in Sec. 558.4 of this chapter does not apply
to any free-choice medicated feed.
(c) An NADA or supplemental NADA for products for free-choice
feeding submitted for approval under section 512(b) of the act shall
provide for:
[[Page 46]]
(1) The manufacture of a finished product for the free-choice
administration of a new animal drug. Such an approval will not provide a
basis upon which an application can be approved under section 512(m) of
the act; or
(2) The manufacture of a Type A medicated article for use in the
subsequent manufacture of a free-choice medicated feed. The approved
NADA will provide a basis upon which an application can be approved
under section 512(m) of the act. Data for a specific free-choice product
may, if desired, be generated and submitted to the Food and Drug
Administration by the manufacturer of the free-choice feed in the form
of a master file which can be referenced in the NADA or supplemental
NADA submitted by the new animal drug sponsor.
(d) Approval of the NADA or supplemental NADA submitted under
paragraph (c) of this section will be reflected in a regulation in part
558 of this chapter published under section 512(i) of the act. The
regulation will either state the formulation of the approved free-choice
product or specify the specific free-choice administration products in
which the drug is approved for use. If the approval is for a Type A
medicated article, the regulation in part 558 of this chapter will
indicate that each use of the Type A medicated article in a free-choice
product must be the subject of an approved supplemental NADA.
(e) An application submitted under section 512(m) of the act to
provide for manufacture of a specific free-choice feed from an approved
Type A medicated article will be approved if, in addition to the
information required by the medicated feed application, it includes a
reference to the exact formula of the product to be manufactured as
follows:
(1) The formula is the same as the one published in the new animal
drug regulations; or
(2) The data in a master file have been referenced in an NADA or
supplemental NADA; and
(3) Use of the Type A medicated article in the specific formulation
has been approved on the basis that:
(i) The formula is the same as the one for which acceptable data
have been submitted in a master file by the medicated feed applicant; or
(ii) The medicated feed applicant has written authority to reference
a master file that has acceptable data for the formula in question.
(Approved by the Office of Management and Budget under control number
0910-0205)
[51 FR 19827, June 3, 1986]
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.515]
[Page 46-47]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart F--Animal Use Exemptions From Certification and Labeling
Requirements
Sec. 510.515 Animal feeds bearing or containing new animal drugs subject to the provisions of section 512(n) of the act.
Animal feeds that bear or contain penicillin, chlortetracycline,
feed grade zinc bacitracin, and bacitracin methylene disalicylate, with
or without added suitable nutritive ingredients are exempt from the
certification requirements of section 512 of the act provided they are
the subject of and in compliance with regulations for their use in this
subchapter E, part 558 of this chapter, or any one of the paragraphs of
this section:
(a) Where indicated in paragraph (b) of this section it is
manufactured with or without one, but only one, of the following
ingredients in a quantity, by weight of feed, as hereinafter indicated:
(1) Arsanilic acid: Not less than 0.005 percent and not more than
0.01 percent.
(2) Sodium arsanilate: Not less than 0.005 percent and not more than
0.01 percent.
(3) 3-Nitro-4-hydroxyphenylarsonic acid: Not less than 0.0025
percent and not more than 0.0075 percent except in chicken or turkey
feed which shall contain not less than 0.0025 percent and not more than
0.005 percent.
(b) It is intended for use in any one of the following conditions
set forth in this paragraph:
(1) It is intended for use solely in the treatment of chronic
respiratory disease (air-sac infection), infectious sinusitis, and blue
comb (nonspecific infectious enteritis) in poultry and/or bacterial
swine enteritis; its labeling bears adequate directions and warnings for
such use; and it contains, per ton of
[[Page 47]]
feed, the equivalent of 100 grams of penicillin. When intended for uses
specified in this paragraph, it may also contain, in the amount
specified, one, but only one, of the ingredients prescribed by paragraph
(a) of this section.
(2) It is intended for use solely in the treatment of chronic
respiratory disease (air-sac infection) and infectious sinusitis in
poultry; its labeling bears adequate directions and warnings for such
use; and it contains not less than 0.1 percent para-aminobenzoic acid or
the sodium or potassium salt or para-aminobenzoic acid.
(3)-(29) [Reserved]
(c) It is intended for use as follows:
----------------------------------------------------------------------------------------------------------------
Product Species Use levels Indications for use
----------------------------------------------------------------------------------------------------------------
1. Nicarbazin................. Chickens................ 0.01 to 0.02 percent..... For use in the prevention
......do................ 2.4 to 50 g/ton.......... of outbreaks of
coccidiosis in poultry
flocks; growth promotion
and feed efficiency.
2. Nicarbazin................. ......do................ 0.01 to 0.02 percent..... Do.
Bacitracin methylene ......do................ 4 to 50 g/ton............
disalicylate.
3. Nicarbazin................. ......do................ 0.01 to 0.02 percent..... For use as an aid in the
prevention of coccidiosis
in poultry flocks; growth
promotion and feed
efficiency; improving
pigmentation.
Bacitracin methylene ......do................ 4 to 50 g/ton............
disalicylate.
3-Nitro-4- ......do................ 0.0025 to 0.005 percent..
hydroxyphenylarsonic acid.
4. Nicarbazin................. ......do................ 0.01 to 0.02 percent..... Do.
Procaine penicillin......... ......do................ 2.4 to 50 g/ton..........
3-Nitro-4- ......do................ 0.0025 to 0.005 percent..
hydroxyphenylarsonic acid.
5. Chlortetracycline.......... Swine................... 10 to 50 g/ton........... Enhancement of growth and
feed efficiency.
Arsanilic acid.............. ......do................ 0.005 to 0.01 percent....
----------------------------------------------------------------------------------------------------------------
[41 FR 8299, Feb. 25, 1976, as amended at 41 FR 11011, Mar. 15, 1976; 42
FR 18614, Apr. 8, 1977; 47 FR 42102, Sept. 24, 1982; 47 FR 51563, Nov.
16, 1982; 56 FR 41912, Aug. 23, 1991; 58 FR 30119, May 26, 1993; 61 FR
35950, July 9, 1996]
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.600]
[Page 47-53]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--(Continued)
PART 510--NEW ANIMAL DRUGS--Table of Contents
Subpart G--Sponsors of Approved Applications
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
(a) Section 512(i) of the act requires publication of names and
addresses of sponsors of approved applications for new animal drugs.
(b) In this section each name and address is identified by a
numerical drug labeler code. The labeler codes identify the sponsors of
the new animal drug applications associated with the regulations
published pursuant to section 512(i) of the act. The codes appear in the
appropriate regulations and serve as a reference to the names and
addresses listed in this section. The drug labeler code is established
pursuant to section 510 of the act.
(c) The names, addresses, and drug labeler codes of sponsors of
approved new animal drug applications are as follows:
(1) Alphabetical Listing of Sponsors
------------------------------------------------------------------------
Drug
Firm name and address labeler
code
------------------------------------------------------------------------
Abbott Laboratories, North Chicago, IL 60064................ 000074
ADM Animal Health & Nutrition Division, 1000 North 30th St., 017519
Box 1C, Quincy, IL 62305-3115..............................
Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464.............. 024174
Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503 057561
Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112....... 017762
Akey, Inc., P.O. Box 607, Lewisburg, OH 45338............... 017790
Akzo Nobel Surface Chemistry AB, Box 851, S-44485 063765
Stenungsund, Sweden........................................
Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson, AZ 064146
85712......................................................
Albion Laboratories, Inc., 101 North Main, Clearfield, UT 011485
84015......................................................
Alpharma Inc., One Executive Drive, P.O. Box 1399, Fort Lee, 046573
NJ 07024...................................................
Alstoe, Ltd., Animal Health, Granary Chambers, 37-39 Burton 062408
St., Melton Mowbray, Leicestershire LE13 1AF, England......
Altana Inc., 60 Baylis Rd., Melville, NY 11747.............. 025463
[[Page 48]]
American Cyanamid, Division of American Home Products, P.O. 010042
Box 1339, Fort Dodge, IA 50501.............................
American Pharmaceuticals Partners, Inc., 2045 North Cornell 063323
Ave., Melrose Park, IL 60160...............................
Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 060865
01801......................................................
Anthony Products Co., 5600 Peck Rd., Arcadia, CA 91006...... 000864
Argent Laboratories, 8702 152d Ave. NE., Redmond, WA 98052.. 051212
Ausa International, Inc., Rt. 8, P.O. Box 324-12, Tyler, TX 059521
75703......................................................
Aventis Animal Nutrition, Inc., 3480 Preston Ridge Rd., 011526
suite 650, Alpharetta, GA 30005-8891.......................
Balfour Guthrie & Co., Ltd., 315 North H St., Fresno, CA 043728
93701......................................................
Baxter Pharmaceutical Products, Inc., 110 Allen Rd., Liberty 010019
Corner, NJ 07938...........................................
Bayer Corp., Agriculture Division, Animal Health, P.O. Box 000859
390, Shawnee, Mission, KS 66201............................
Bimeda, Inc., 288 County Rd. 28, LeSueur, MN 56058-9322..... 061133
Biocraft Laboratories, Inc., 92 Route 46, Elmwood Park, NJ 000332
07407......................................................
Bioproducts, Inc., 320 Springside Dr., Suite 300, Fairlawn, 051359
OH 44333-2435..............................................
Biopure Corp., 11 Hurley St., Cambridge, MA 02141........... 063075
BioScience Division of Milk Specialties Co., Illinois and 032761
Water Sts., P.O. Box 278, Dundee, IL 60118.................
Blue Ridge Pharmaceuticals, Inc., 4249-105 Piedmont Pkwy., 065274
Greensboro, NC 27410.......................................
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt 000010
Highway, St. Joseph, MO 64506-2002.........................
Carnation Co., 5045 Wilshire Blvd., Los Angeles, CA 90036... 047019
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, 061651
County Galway, Ireland.....................................
Chemdex, Inc., 12340 Santa Fe Dr., Lenexa, KS 66215......... 017287
Combe, Inc., 1101 Westchester Ave., White Plains, NY 10604.. 011509
ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 021091
68105......................................................
Contemporary Products, Inc., 3788 Elm Springs Rd., 055462
Springdale, AR 72764-6067..................................
Cooperative Research Farms, Box 69, Charlotteville, NY 12036 051267
Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 061623
24, Ireland................................................
Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 046987
50501......................................................
Custom Feed Services Corp., 2100 N. 13th St., Norfolk, NE 017473
68701......................................................
Cyanamid Agricultural de Puerto Rico, Inc., P.O. Box 243, 043781
Manati, PR 00701...........................................
Delmarva Laboratories, Inc., 2200 Wadebridge Rd., P.O. Box 059079
525, Midlothian, VA 23113..................................
Diamond Shamrock Corp., Nutrition & Animal Health Div., 1100 025001
Superior Ave., Cleveland, OH 44114.........................
DuPont Merck Pharmaceutical Co., DuPont Merck Plaza, MR2117, 000056
Wilmington, DE 19805.......................................
Elanco Animal Health, A Division of Eli Lilly & Co., Lilly 000986
Corporate Center, Indianapolis, IN 46285...................
Endo Pharmaceuticals, Inc., 223 Wilmington West Chester 060951
Pike, Chadds Ford, PA 19317................................
Eon Labs Manufacturing, Inc. 227-15 North Conduit Ave., 000185
Laurelton, NY 11413........................................
Equi Aid Products, Inc., 1517 West Knudsen Dr., Phoenix, AZ 062240
85027......................................................
Evsco Pharmaceuticals, An Affiliate of IGI, Inc., Box 209, 017030
Harding Hwy., Buena, NJ 08310..............................
Farmers Feed & Supply Co., Ninth St. at Northwestern Tracks, 043744
Tipton, IA 52772...........................................
Farmland Industries, Inc., Kansas City, MO 64116............ 021676
Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013- 017135
3928.......................................................
Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, 030841
Mankato, MN 56001..........................................
John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611....... 058034
First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123... 058829
Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 015565
28234......................................................
Fort Dodge Animal Health, A Division of American Cyanamid 053501
Co., P.O. Box 1339, Fort Dodge, IA 50501...................
Fort Dodge Animal Health, Division of American Home Products 000856
Corp., 800 Fifth St. NW., Fort Dodge, IA 50501.............
Franklin Laboratories, Inc., P.O. Box 717, Fort Dodge, IA 010290
50501......................................................
Furst-McNess Co., Freeport, IL 61032........................ 010439
Gland-O-Lac Co., 1818 Leavenworth St., Omaha, NE 68102...... 043735
Golden Sun Feeds, Inc., 111 South Fifth St., Estherville, IA 021780
51334......................................................
Michael Gordon, Inc., P.O. Box 8091, San Francisco, CA 94118 049047
Gossett Nutrition, Inc., 1676 Cascade Dr., Marion, OH 43302. 050972
G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 010515
13201......................................................
Halocarbon Laboratories, Division of Halocarbon Products 012164
Corp., 887 Kinderkamack Rd., P.O. Box 661, River Ridge, NJ
07661......................................................
Happy Jack, Inc., Snow Hill, NC 28580....................... 023851
Heinold Feeds, Inc., P.O. Box 377, Kouts, IN 46347.......... 043727
Henwood Feed Additives, Division of Feed Specialties Co., 026186
Inc., 211 Western Rd., Box 577, Lewisburg, OH 45338........
Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525... 063604
Hess & Clark, Inc., Seventh and Orange Sts., Ashland, OH 050749
44805......................................................
Dow B. Hickam, Inc., Pharmaceuticals, P.O. Box 35413, 000514
Houston, TX 77035..........................................
Hoechst Roussel Vet, Perryville Corporate Park III, P.O. Box 012799
4010, Clinton, NJ 08809-4010...............................
Hubbard Milling Co., 424 North Front St., Mankato, MN 56001. 012190
I.M.S. Inc., 13619 Industrial Rd., Omaha, NE 68137.......... 050639
Illini Feeds, Box T, Oneida, IL 61467....................... 037310
IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 000115
94544......................................................
Inhalon Pharmaceuticals, Inc., P.O. Box 21170, Lehigh 060307
Valley, PA 18002...........................................
International Nutrition, Inc., 7706 `I' Plaza, Omaha, NE 043733
68127......................................................
[[Page 49]]
Intervet, Inc., P.O. Box 318, 405 State St., Millsboro, DE 057926
19966......................................................
Ivy Laboratories, Div. of Ivy Animal Health, Inc., 8857 Bond 021641
Street, Overland Park, KS 66214............................
J. C. Feed Mills, 1050 Sheffield, P.O. Box 224, Waterloo, IA 039741
50704......................................................
Jorgensen Laboratories, Inc., 1450 North Van Buren Ave., 045087
Loveland, CO 80538.........................................
K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214... 038782
Kerber Milling Co., Box 152, 1817 E. Main St., Emmetsburg, 029341
IA 50536...................................................
Koffolk, Inc., P.O. Box 675935, 14735 Las Quintas, Rancho 063271
Santa Fe, CA 92067.........................................
Lambert-Kay, A Division of Carter-Wallace, Inc., P.O. Box 011615
1001, Half Acre Rd., Cranbury, NJ 08512-0181...............
Lemmon Co., Sellersville, PA 18960.......................... 000693
Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601....... 061690
Luitpold Pharmaceuticals, Inc., Animal Health Division, 010797
Shirley, NY 11967..........................................
M & M Livestock Products Co., Eagle Grove, IA 50533......... 026282
Macleod Pharmaceuticals, Inc., 2600 Canton Ct., Fort 058711
Collins, CO 80525..........................................
Marsam Pharmaceuticals, Inc., Bldg. 31, 24 Olney Ave., 000209
Cherry Hill, NJ 08034......................................
Mattox & Moore, Inc., 1503 East Riverside Drive, 027863
Indianapolis, IN 46207.....................................
McClellan Laboratories, Inc., 19600 Sixth Ave., Lakeview, CA 043738
92353......................................................
Medicis Dermatologics, Inc., 8125 North Hayden Rd., 099207
Scottsdale, AZ 85258.......................................
Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767- 051259
1861.......................................................
Merial Ltd., 2100 Ronson Rd., Iselin, NJ 08830-3077......... 050604
Micro Chemical, Inc., Amarillo, TX 79105.................... 047126
Mid-Continent Agrimarketing, Inc., 8833 Quivira Rd., 059620
Overland Park, KS 66214....................................
Monsanto Co., 800 North Lindbergh Blvd., St. Louis, MO 63167 059945
MoorMan's, Inc., 1000 North 30th St., Quincy, IL 62305-3115. 021930
Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, 049968
MS 39120...................................................
Nixon and Co., Kiewitt Plaza, Omaha, NE 88501............... 043729
Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, 055529
Northern Ireland...........................................
Norco Mills of Norfolk, Inc., P.O. Box 56, Norfolk, NE 68701 027190
Novartis Animal Health US, Inc., 3200 Northline Ave., suite 058198
300, Greensboro, NC 27408..................................
Nutra-Blend Corp., P.O. Box 485, Neosho, MO 64850........... 050568
NutriBasics Co., North Highway 71, P.O. Box 1014, WIllmar, 053740
MN 56201...................................................
Nylos Trading Co., Inc., P.O. Box 2, Route 202, Pomona, NY 027454
10970......................................................
Orion Corp. ORION-FARMOS, P.O. Box 425, SF-20101 Turku, 052483
Finland....................................................
Orphan Medical, Inc., 13911 Ridgedale Dr., Suite 475, 062161
Minnetonka, MN 55305.......................................
Osborn Laboratories, Inc., 2d and Oak Sts., Le Sueur, MN 012487
56058......................................................
OXIS International, Inc., 6040 N. Cutter Circle, Suite 317, 024991
Portland, OR 97217-3935....................................
Peavey Co., 730 Second Ave. South, Minneapolis, MN 55402.... 028459
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 055246
32514......................................................
Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68137.... 053389
Peptech Animal Health Pty, Ltd., 35-41 Waterloo Rd., North 064288
Ryde, New South Wales 2113, Australia......................
Peter Hand Foundation, 2 East Madison St., Waukegan, IL 043737
60085......................................................
Pfizer, Inc., 235 East 42d St., New York, NY 10017.......... 000069
Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 000009
49001-0199.................................................
Phoenix Pharmaceutical, Inc., 4621 Easton Rd., P.O. Box 6457 057319
Farleigh Station, St. Joseph, MO 64506-0457................
Phoenix Scientific, Inc. 3915 South 48th St. Terrace, P.O. 059130
Box 6457, St. Joseph, MO 64506-0457........................
Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, 060728
Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Paulo,
Brazil.....................................................
Pliva d.d., Ulica grada Vukovara 49, 10000 Zagreb, Croatia.. 011722
PM Resources, Inc., 13001 St. Charles Rock Rd., Bridgeton, 060594
MO 63044...................................................
Premier Malt Products, Inc., Milwaukee, WI 53201............ 032707
Protein Blenders, Inc., Box 631, Highway 218 South, Iowa 033999
City, IA 52240.............................................
Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-6812 017800
Quali-Tech Products, Inc., 318 Lake Hazeltine Drive, Chaska, 016968
MN 55318...................................................
The Rath Packing Co., P.O. Box 330, Waterloo, IA 50704...... 028260
Rhodia Limited, P.O. Box 46, St. Andrews Rd., Avonmouth, 059258
Bristol BS11 9YF, England, UK..............................
Rhone Merieux Canada, Inc., 345 Boul. Labbe Blvd., North 047015
Victoriaville, QC, G6P 1B1 Canada..........................
A. H. Robins Co., P.O. Box 518, Fort Dodge, IA 50501-0518... 000031
Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 063238
07054-1298.................................................
RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620.... 058670
R. P. Scherer North America, P.O. Box 5600, Clearwater, FL 011014
33518......................................................
Schering-Plough Animal Health Corp., 1095 Morris Ave., 000061
Union, NJ 07083............................................
G. D. Searle & Co., P.O. Box 5110, Chicago, IL 60680........ 000014
Seeco Inc., Box 1014, North Highway 71, Willmar, MN 56201... 011749
Shell Chemical Co., Division of Shell Oil Co., Animal 011461
Health, One Shell Plaza, Houston, TX 77001.................
Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 063112
51250......................................................
South St. Paul Feeds, Inc., 500 Farwell Ave., South St. 001800
Paul, MN 55075.............................................
Southern Micro-Blenders, Inc., 3801 North Hawthorne St., 049685
Chattanooga, TN 37406......................................
Springfield Milling Corp., Vigorena Feeds, Springfield, MN 035955
56087......................................................
Square Deal Fortification Co., Kouts, IN 46347.............. 036108
[[Page 50]]
Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151... 017153
Steris Laboratories, Inc., 620 North 51st Ave., Phoenix, AZ 000402
85043-4705.................................................
Sterling Winthrop, Inc., 9 Great Valley Pkwy., Malvern, PA 000934
19355......................................................
Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752.. 037990
Sweetlix, LLC, 175 South Main St., suite 150, Salt Lake 036904
City, UT 84111.............................................
Syntex Animal Health, Division of Syntex Agribusiness, Inc., 000033
3401 Hillview Ave., Palo Alto, CA 94304....................
Teva Pharmaceuticals USA, 650 Cathill Rd., Sellersville, PA 000093
18960......................................................
Tevcon Ind., Inc., 8904 J St., Omaha, NE 68127.............. 011757
Texas Vitamin Co., P.O. Box 18417, 10695 Aledo St., Dallas, 000842
TX 57218...................................................
Triple ``F'', Inc., 10104 Douglas Ave., Des Moines, IA 50322 011490
United Vaccines, A Harlan Sprague Dawley, Inc., Co., P.O. 058639
Box 4220, Madison, WI 53711................................
V.P.O., Inc., 4444 S. 76th St., Omaha, NE 68127............. 043743
Vet-A-Mix, Inc., P.O. Box A, Shenandoah, IA 51601........... 011789
Vetem, S.p.A., Viale E. Bezzi 24, 20146 Milano, Italy....... 055882
Veterinary Laboratories, Inc., 12340 Santa Fe Dr., Lenexa, 000857
KS 66215...................................................
Veterinary Research Associates, Inc., 2817 West Country Rd. 064408
54G, Fort Collins, CO 80524................................
Veterinary Service, Inc., 416 North Jefferson St., P.O. Box 033008
2467, Modesto, CA 95354....................................
Veterinary Specialties Inc., 387 North Valley Ct., 062925
Barrington, IL 60010.......................................
Vetoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), 059320
Canada, J0K 1H0............................................
Walco International, Inc., 15 West Putnam, Porterville, CA 049185
93257
Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704.. 017139
Wayne Feed Division, Continental Grain Co., P.O. Box 459, 034936
Libertyville, IL 60048.....................................
Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363............. 035098
Wellmark International, 1100 East Woodfield Rd., suite 500, 011536
Schaumburg, IL 60173.......................................
Wendt Laboratories , Inc., 100 Nancy Dr., Belle Plaine, MN 015579
56011......................................................
West Agro, Inc., 11100 N. Congress Ave., Kansas City, MO 033392
64153......................................................
Westchester Veterinary Products, Inc., 180 Mamaroneck Ave., 043732
White Plains, NY 10601.....................................
Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 050378
98248......................................................
Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort 053923
Collins, CO 80524..........................................
Wyeth Laboratories, Division American Home Products Corp., 000008
P.O. Box 8299, Philadelphia, PA 19101......................
Yoder Feed, Division of Yoder, Inc., Kalona, IA 52247....... 035369
Young's Inc., Roaring Spring, PA 16673...................... 035393
Zema Corp., P.O. Box 12803, Research Triangle Park, Durham, 050906
NC 27709...................................................
------------------------------------------------------------------------
(2) Numerical Listing of Sponsors
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
000008............................. Wyeth Laboratories, Division
American Home Products Corp., P.O.
Box 8299, Philadelphia, PA 19101.
000009............................. Pharmacia & Upjohn Co., 7000
Portage Rd., Kalamazoo, MI 49001-
0199.
000010............................. Boehringer Ingelheim Vetmedica,
Inc., 2621 North Belt Highway, St.
Joseph, MO 64506-2002.
000014............................. G. D. Searle & Co., P.O. Box 5110,
Chicago, IL 60680.
000031............................. A. H. Robins Co., P.O. Box 518,
Fort Dodge, IA 50501-0518.
000033............................. Syntex Animal Health Division of
Syntex Agribusiness, Inc., 3401
Hillview Ave., Palo Alto, CA
94304.
000056............................. DuPont Merck Pharmaceutical Co.,
DuPont Merck Plaza, MR2117,
Wilmington, DE 19805.
000061............................. Schering-Plough Animal Health
Corp., 1095 Morris Ave., Union, NJ
07083.
000069............................. Pfizer, Inc., 235 East 42d St., New
York, NY 10017.
000074............................. Abbott Laboratories, North Chicago,
IL 60064.
000093............................. Teva Pharmaceuticals USA, 650
Cathill Rd., Sellersville, PA
18960.
000115............................. IMPAX Laboratories, Inc., 30831
Huntwood Ave., Hayward, CA 94544.
000185............................. Eon Labs Manufacturing, Inc., 227-
15 North Conduit Ave., Laurelton,
NY 11413.
000209............................. Marsam Pharmaceuticals, Inc., Bldg.
31, 24 Olney Ave., Cherry Hill, NJ
08034.
000332............................. Biocraft Laboratories, Inc., 92
Route 46, Elmwood Park, NJ 07407.
000402............................. Steris Laboratories, Inc., 620
North 51st Ave., Phoenix, AZ 85043-
4705.
000514............................. Dow B. Hickam, Inc.,
Pharmaceuticals, P.O. Box 35413,
Houston, TX 77035.
000693............................. Lemmon Co., Sellersville, PA 18960.
000842............................. Texas Vitamin Co., P.O. Box 18417,
10695 Aledo St., Dallas, TX 57218.
000856............................. Fort Dodge Animal Health, Division
of American Home Products Corp.,
800 Fifth St. NW., Fort Dodge, IA
50501.
000857............................. Veterinary Laboratories, Inc.,
12340 Santa Fe Dr., Lenexa, KS
66215.
000859............................. Bayer Corp., Agriculture Division,
Animal Health, P.O. Box 390,
Shawnee Mission, KS 66201.
000864............................. Anthony Products Co., 5600 Peck
Rd., Arcadia, CA 91006.
000934............................. Sterling Winthrop, Inc., 9 Great
Valley Pkwy., Malvern, PA 19335.
000986............................. Elanco Animal Health, A Division of
Eli Lilly & Co., Lilly Corporate
Center, Indianapolis, IN 46285.
001800............................. South St. Paul Feeds, Inc., 500
Farwell Ave., South St. Paul, MN
55075.
010019............................. Baxter Pharmaceutical Products,
Inc., 110 Allen Rd., Liberty
Corner, NJ 07938-0804.
010042............................. American Cyanamid, Division of
American Home Products, P.O. Box
1339, Fort Dodge, IA 50501
010290............................. Franklin Laboratories, Inc., P.O.
Box 717, Fort Dodge, IA 50501.
010290............................. Franklin Laboratories, P.O. Box
669, Amarillo, TX 79105.
010439............................. Furst-McNess Co., Freeport, IL
61032.
010515............................. G. C. Hanford Manufacturing Co.,
P.O. Box 1017, Syracuse, NY 13201.
[[Page 51]]
010797............................. Luitpold Pharmaceuticals, Inc.,
Animal Health Division, Shirley,
NY 11967.
011014............................. R. P. Scherer North America, P.O.
Box 5600, Clearwater, FL 33518.
011461............................. Shell Chemical Co., Division of
Shell Oil Co., Animal Health, One
Shell Plaza, Houston, TX 77001.
011485............................. Albion Laboratories, Inc., 101
North Main, Clearfield, UT 84015.
011490............................. Triple ``F'', Inc., 10104 Douglas
Ave., Des Moines, IA 50322
011509............................. Combe, Inc., 1101 Westchester Ave.,
White Plains, NY 10604.
011526............................. Aventis Animal Nutrition, Inc.,
3480 Preston Ridge Rd., suite 650,
Alpharetta, GA 30005-8891
011536............................. Wellmark International, 1100 East
Woodfield Rd., suite 500,
Schaumburg, IL 60173
011615............................. Lambert-Kay, A Division of Carter-
Wallace, Inc., P.O. Box 1001, Half
Acre Rd., Cranbury, NJ 08512-0181.
011722............................. Pliva d.d., Ulica grada Vukovara
49, 10000 Zagreb, Croatia
011749............................. Seeco Inc., Box 1014, North Highway
71, Willmar, MN 56201.
011789............................. Vet-A-Mix, Inc., P.O. Box A,
Shenandoah, IA 51601.
012164............................. Halocarbon Laboratories, Division
of Halocarbon Products Corp., 887
Kinderkamack Rd., P.O. Box 661,
River Ridge, NJ 07661.
012190............................. Hubbard Milling Co., 424 North
Front St., Mankato, MN 56001.
012487............................. Osborn Laboratories, Inc., 2d and
Oak Sts., Le Sueur, MN 56058.
012799............................. Hoechst Roussel Vet, Perryville
Corporate Park III, P.O. Box 4010,
Clinton, NJ 08809-4010.
015565............................. Fleming Laboratories, Inc., P.O.
Box 34384, Charlotte, NC 28234.
015579............................. Wendt Laboratories, Inc., 100 Nancy
Dr., Belle Plaine, MN 56011.
016968............................. Quali-Tech Products, Inc., 318 Lake
Hazeltine Dr., Chaska, MN 55318.
017030............................. Evsco Pharmaceuticals, An Affiliate
of IGI, Inc., Box 209, Harding
Hwy., Buena, NJ 08310.
017135............................. Farnam Companies, Inc., 301 West
Osborn, Phoenix, AZ 85013-3928.
017139............................. Waterloo Mills Co., 2050 Mitchell
Ave., Waterloo, IA 50704.
017153............................. Squire Laboratories, Inc., 100 Mill
St., Revere, MA 02151.
017287............................. Chemdex, Inc., 12340 Santa Fe Dr.,
Lenexa, KS 66215.
017473............................. Custom Feed Services Corp., 2100 N.
13th St., Norfolk, NE 68701.
017519............................. ADM Animal Health & Nutrition
Division, 1000 North 30th St., Box
1C, Quincy, IL 62305-3115
017762............................. Agri-Tech, Inc., 4722 Broadway,
Kansas City, MO 64112.
017790............................. Akey, Inc., P.O. Box 607,
Lewisburg, OH 45338.
017800............................. Purina Mills, Inc., P.O. Box 66812,
St. Louis, MO 63166-6812.
021091............................. ConAgra Pet Products Co., 3902
Leavenworth St., Omaha, NE 68105.
021641............................. Ivy Laboratories, Div. of Ivy
Animal Health, Inc., 8857 Bond
Street, Overland Park, KS 66214.
021676............................. Farmland Industries, Inc., Kansas
City, MO 64116.
021780............................. Golden Sun Feeds, Inc., 111 South
Fifth St., Estherville, IA 51334.
021930............................. MoorMan's, Inc., 1000 North 30th
St., Quincy, IL 62305-3115.
023851............................. Happy Jack, Inc., Snow Hill, NC
28580.
024174............................. Ag-Mark, Inc., P.O. Box 127,
Teachey, NC 28464.
024991............................. OXIS International, Inc., 6040 N.
Cutter Circle, Suite 317 Portland,
OR 97217-3935.
025001............................. Diamond Shamrock Corp., Nutrition &
Animal Health Div., 1100 Superior
Ave., Cleveland, OH 44114.
025463............................. Altana Inc., 60 Baylis Rd.,
Melville, NY 11747.
026186............................. Henwood Feed Additives, Division of
Feed Specialties Co., Inc., 211
Western Rd., Box 577, Lewisburg,
OH 45338.
026282............................. M & M Livestock Products Co., Eagle
Grove, IA 50533.
027190............................. Norco Mills of Norfolk, Inc., P.O.
Box 56, Norfolk, NE 68701.
027454............................. Nylos Trading Co., Inc., P.O. Box
2, Route 202, Pomona, NY 10970.
027863............................. Mattox & Moore, Inc., 1503 East
Riverside Dr., Indianapolis, IN
46207.
028260............................. The Rath Packing Co., P.O. Box 330,
Waterloo, IA 50704.
028459............................. Peavey Co., 730 Second Ave. South,
Minneapolis, MN 55402.
029341............................. Kerber Milling Co., Box 152, 1817
E. Main St., Emmetsburg, IA 50536.
030841............................. Feed Service Co., Inc., 303 Lundin
Blvd., P.O. Box 698, Mankato, MN
56001.
032707............................. Premier Malt Products, Inc.,
Milwaukee, WI 53201.
032761............................. BioScience Division of Milk
Specialties Co., Illinois and
Water Sts., P.O. Box 278, Dundee,
IL 60118.
033008............................. Veterinary Service, Inc., 416 North
Jefferson St., P.O. Box 2467,
Modesto, CA 95354.
033392............................. West Agro, Inc., 11100 N. Congress
Ave., Kansas City, MO 64153.
033999............................. Protein Blenders, Inc., Box 631,
Highway 218 South, Iowa City, IA
52240.
034936............................. Wayne Feed Division, Continental
Grain Co., P.O. Box 459,
Libertyville, IL 60048.
035098............................. Webel Feeds, Inc., R.R. 3,
Pittsfield, IL 62363.
035369............................. Yoder Feed, Division of Yoder,
Inc., Kalona, IA 52247.
035393............................. Young's, Inc., Roaring Spring, PA
16673.
035955............................. Springfield Milling Corp., Vigorena
Feeds, Springfield, MN 56087.
036108............................. Square Deal Fortification Co.,
Kouts, IN 46347.
036904............................. Sweetlix, LLC, 175 South Main St.,
suite 150, Salt Lake City, UT
84111.
037310............................. Illini Feeds, Box T, Oneida, IL
61467.
037990............................. Summit Hill Laboratories, P.O. Box
535, Navesink, NJ 07752.
038782............................. K. C. Pharmacal, Inc., 8345 Melrose
Dr., Lenexa, KS 66214.
039741............................. J. C. Feed Mills, 1050 Sheffield,
P.O. Box 224, Waterloo, IA 50704.
[[Page 52]]
043727............................. Heinold Feeds, Inc., P.O. Box 377,
Kouts, IN 46347.
043728............................. Balfour Guthrie & Co., Ltd., 315
North H St., Fresno, CA 93701.
043729............................. Nixon and Co., Kiewitt Plaza,
Omaha, NE 88501.
043732............................. Westchester Veterinary Products,
Inc., 180 Mamaroneck Ave., White
Plains, NY 10601.
043733............................. International Nutrition, Inc., 7706
`I' Plaza, Omaha, NE 68127
043735............................. Gland-O-Lac Co., 1818 Leavenworth
St., Omaha, NE 68102.
043737............................. Peter Hand Foundation, 2 East
Madison St., Waukegan, IL 60085.
043738............................. McClellan Laboratories, Inc., 19600
Sixth Ave., Lakeview, CA 92353.
043743............................. V.P.O., Inc., 4444 South 76th St.,
Omaha, NE 68127.
043744............................. Farmers Feed & Supply Co., Ninth
St. at Northwestern Tracks,
Tipton, IA 52772.
043781............................. Cyanamid Agricultural de Puerto
Rico, Inc., P.O. Box 243, Manati,
PR 00701.
045087............................. Jorgensen Laboratories, Inc., 1450
North Van Buren Ave., Loveland, CO
80538.
046573............................. Alpharma Inc., One Executive Drive,
P.O. Box 1399, Fort Lee, NJ 07024.
046987............................. Custom Feed Blenders Corp., 540
Hawkeye Ave., Fort Dodge, IA
50501.
047015............................. Rhone Merieux Canada, Inc., 345
Boul. Labbe Blvd., North
Victoriaville, QC, G6P 1B1 Canada.
047019............................. Carnation Co., 5045 Wilshire Blvd.,
Los Angeles, CA 90036.
047126............................. Micro Chemical, Inc., Amarillo, TX
79105.
049047............................. Michael Gordon, Inc., P.O. Box
1091, San Francisco, CA 94118.
049185............................. Walco International, Inc., 15 West
Putnam, Porterville, CA 93257.
049685............................. Southern Micro-Blenders, Inc., 3801
North Hawthorne St., Chattanooga,
TN 37406.
049968............................. Natchez Animal Supply Co., 201 John
R. Junkin Dr., Natchez, MS 39120.
050378............................. Western Chemical, Inc., 1269
Lattimore Rd., Ferndale, WA 98248.
050568............................. Nutra-Blend Corp., P.O. Box 485,
Neosho, MO 64850.
050604............................. Merial Ltd., 2100 Ronson Rd.,
Iselin, NJ 08830-3077.
050639............................. I.M.S. Inc., 13619 Industrial Rd.,
Omaha, NE 68137.
050749............................. Hess & Clark, Inc., Seventh and
Orange Sts., Ashland, OH 44805.
050906............................. Zema Corp., P.O. Box 12803,
Research Triangle Park, Durham, NC
27709.
050972............................. Gossett Nutrition, Inc., 1676
Cascade Dr., Marion, OH 43302.
051212............................. Argent Laboratories, 8702 152d Ave.
NE., Redmond, WA 98052.
051259............................. Med-Pharmex, Inc., 2727 Thompson
Creek Rd., Pomona, CA 91767-1861.
051267............................. Cooperative Research Farms, Box 69,
Charlotteville, NY 12036.
051359............................. Bioproducts, Inc., 320 Springside
Dr., Suite 300, Fairlawn, OH
44141.
052483............................. Orion Corp. ORION-FARMOS, P.O. Box
425, SF-20101 Turku, Finland.
053389............................. Pennfield Oil Co., 14040 Industrial
Rd., Omaha, NE 68137.
053501............................. Fort Dodge Animal Health, A
Division of American Cyanamid Co.,
P.O. Box 1339, Fort Dodge, IA
50501.
053740............................. NutriBasics Co., North Highway 71,
P.O. Box 1014, WIllmar, MN 56201.
053923............................. Wildlife Laboratories, Inc., 1401
Duff Dr., Suite 600, Fort Collins,
CO 80524.
055246............................. Pegasus Laboratories, Inc., 8809
Ely Rd., Pensacola, FL 32514.
055462............................. Contemporary Products, Inc., 3788
Elm Springs Rd., Springdale, AR
72764-6067.
055529............................. Norbrook Laboratories, Ltd.,
Station Works, Newry BT35 6JP,
Northern Ireland.
055882............................. Vetem, S.p.A., Viale E. Bezzi 24,
20146 Milano, Italy.
057319............................. Phoenix Pharmaceutical, Inc., 4621
Easton Rd., P.O. Box 6457 Farleigh
Station, St. Joseph, MO 64506-
0457.
057561............................. Agri Laboratories, Ltd., P.O. Box
3103, St. Joseph, MO 64503.
057926............................. Intervet, Inc., P.O. Box 318, 405
State St., Millsboro, DE 19966.
058034............................. John J. Ferrante, 11 Fairway Lane,
Trumbull, CT 06611.
058198............................. Novartis Animal Health US, Inc.,
3200 Northline Ave., suite 300,
Greensboro, NC 27408.
058639............................. United Vaccines, A Harlan Sprague
Dawley, Inc., Co., P.O. Box 4220,
Madison, WI 53711.
058670............................. RSR Laboratories, Inc., 501 Fifth
St., Bristol, TN 37620.
058711............................. Macleod Pharmaceuticals, Inc., 2600
Canton Ct., Fort Collins, CO
80525.
058829............................. First Priority, Inc., 1585 Todd
Farm Dr., Elgin, IL 60123.
059079............................. Delmarva Laboratories, Inc., 2200
Wadebridge Rd., P.O. Box 525,
Midlothian, VA 23113.
059130............................. Phoenix Scientific, Inc. 3915 South
48th St. Terrace, P.O. Box 6457,
St. Joseph, MO 64506-0457
059258............................. Rhodia Limited, P.O. Box 46, St.
Andrews Rd., Avonmouth, Bristol
BS11 9YF, England, UK.
059320............................. Vetoquinol N.-A., Inc., 2000 chemin
Georges, Lavaltrie (PQ), Canada,
J0K 1H0
059945............................. Monsanto Co., 800 North Lindbergh
Blvd., St. Louis, MO 63167.
059521............................. Ausa International, Inc., Rt. 8,
P.O. Box 324-12, Tyler, TX 75703.
059620............................. Mid-Continent Agrimarketing, Inc.,
8833 Quivira Rd., Overland Park,
KS 66214.Blvd., St. Louis, MO
63167.
060307............................. Inhalon Pharmaceuticals, Inc., P.O.
Box 21170, Lehigh Valley, PA
18002.
060594............................. PM Resources, Inc., 13001 St.
Charles Rock Rd., Bridgeton, MO
63044.
060728............................. Planalquimica Industrial Ltda., Rua
das Magnolias nr. Jardim das
Bandeiras, CEP 13053-120,
Campinas, Sao Alto, Brazil.
060865............................. Anika Therapeutics Inc., 236 West
Cummings Park, Woburn, MA 01801.
060951............................. Endo Pharmaceuticals, Inc., 223
Wilmington West Chester Pike,
Chadds Ford, PA 19317.
[[Page 53]]
061133............................. Bimeda, Inc., 288 County Rd. 28,
LeSueur, MN 56058-9322
061623............................. Cross Vetpharm Group Ltd.,
Broomhill Rd., Tallaght, Dublin
24, Ireland.
061651............................. Chanelle Pharmaceuticals
Manufacturing Ltd., Loughrea,
County Galway, Ireland.
061690............................. Lloyd, Inc., 604 W. Thomas Ave.,
Shenandoah, IA 51601.
062161............................. Orphan Medical, Inc., 13911
Ridgedale Dr., Suite 475,
Minnetonka, MN 55305.
062240............................. Equi Aid Products, Inc., 1517 West
Knudsen Dr., Phoenix, AZ 85027.
062408............................. Alstoe, Ltd., Animal Health,
Granary Chambers, 37-39 Burton
St., Melton Mowbray,
Leicestershire LE13 1AF, England.
062925............................. Veterinary Specialties Inc., 387
North Valley Ct., Barrington, Il
60010.
063075............................. Biopure Corp., 11 Hurley St.,
Cambridge, MA 02141.
063112............................. Sioux Biochemical, Inc., 204 Third
St. NW., Sioux Center, IA 51250.
063238............................. Roche Vitamins, Inc., 45 Waterview
Blvd., Parsippany, NJ 07054-1298.
063271............................. Koffolk, Inc., P.O. Box 675935,
14735 Las Quintas, Rancho Santa
Fe, CA 92067.
063323............................. American Pharmaceuticals Partners,
Inc., 2045 North Cornell Ave.,
Melrose Park, IL 60160.
063604............................. Heska Corp., 1825 Sharp Point Dr.,
Fort Collins, CO 80525.
063765............................. Akzo Nobel Surface Chemistry AB,
Box 851, S-44485 Stenungsund,
Sweden.
064146............................. Alaco, Inc., 1500 North Wilmot Rd.,
suite 290-C, Tucson, AZ 85712.
064288............................. Peptech Animal Health Pty, Ltd., 35-
41 Waterloo Rd., North Ryde, New
South Wales 2113, Australia.
064408............................. Veterinary Research Associates,
Inc., 2817 West Country Rd. 54G,
Fort Collins, CO 80524
065274............................. Blue Ridge Pharmaceuticals, Inc.,
4249-105 Piedmont Pkwy.,
Greensboro, NC 27410
099207............................. Medicis Dermatologics, Inc., 8125
North Hayden Rd., Scottsdale, AZ
85258
------------------------------------------------------------------------
[40 FR 13807, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting
Sec. 510.600, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
![[CDRH Home Page]](http://www.fda.gov/cdrh/new-hmpag.gif){kind=small}
![[FDA HomePage]](http://www.fda.gov/cdrh/new-iconhome.gif){kind=small}
![[Comments]](http://www.fda.gov/cdrh/new-iconcomm.gif){kind=small}