[Federal Register Volume 59, Number 163 (Wednesday, August 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20640]
[[Page Unknown]]
[Federal Register: August 24, 1994]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 112
[Docket No. 92-098-2]
Viruses, Serums, Toxins, and Analogous Products; Packaging and
Labeling
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: This rule amends the regulations pertaining to packaging and
labeling of veterinary biological products by prohibiting final
containers of product that are imported or that are packaged at
licensed establishments in cartons or other containers from being
repackaged and relabeled for sale or distribution. The rule also
clarifies that, unless otherwise authorized, labeling may only be
performed at a licensed establishment or by the producer of an imported
product, and amends the ``Applicability'' statement in the regulations
on packaging and labeling to clarify its intent.
The action is necessary in order to ensure that veterinary
biological products are not rendered worthless, contaminated,
dangerous, or harmful because of incomplete, unclear, misleading, or
inappropriate labeling. The effect of the final rule is to ensure that
product integrity is maintained and that the purchasers of biological
products are provided with appropriate and accurate labeling which
complies with the pertinent rules and regulations.
EFFECTIVE DATE: February 21, 1995.
FOR FURTHER INFORMATION CONTACT: Dr. David A. Espeseth, Deputy
Director, Veterinary Biologics, BBEP, APHIS, USDA, room 838, Federal
Building, 6505 Belcrest Road, Hyattsville, MD 20782, (301) 436-8245.
SUPPLEMENTARY INFORMATION:
Background
The Virus-Serum-Toxin Act (21 U.S.C. 151-159; hereinafter the Act),
as amended by the 1985 Food Security Act, prohibits the shipment of
veterinary biological products anywhere in or from the United States
that are worthless, contaminated, dangerous or harmful. It also
prohibits such shipment of products unless they are prepared pursuant
to USDA regulations in an establishment licensed by USDA. The term
``preparation'', as it is defined in the regulations, includes
packaging and labeling. The 1985 amendments granted additional
rulemaking authority to implement the purposes of the Act. Under the
Act and regulations, the Animal and Plant Health Inspection Service
(APHIS) of the U.S. Department of Agriculture grants licenses for
veterinary biological products which are pure, safe, potent, and
efficacious when used according to label instructions. Complete
labeling (either on the product or accompanying the product) must be
reviewed and approved by APHIS in accordance with 9 CFR 112.5 prior to
its use.
On April 28, 1993, we published in the Federal Register a proposed
rule on packaging and labeling of veterinary biologics (see Docket No.
92-098-1, 58 FR 25786-25788). We proposed to amend the regulations
pertaining to packaging and labeling of veterinary biological products
by prohibiting final containers of product packaged at licensed
establishments in cartons or other containers from being repackaged for
sale or distribution. We also proposed to clarify that, unless
otherwise authorized, labeling may only be performed at a licensed
establishment and to amend the ``Applicability'' statement in the
regulations on packaging and labeling to clarify its intent.
We solicited comments concerning our proposal during a 60-day
comment period ending June 28, 1993. We received 39 comments by that
date. Comments were received from biologics manufacturers, State and
national professional associations, a trade association, an educational
institution, animal hospitals and clinics, veterinarians, a registered
pharmacist, a practicing attorney, and private citizens.
Thirty-six commenters were in support of the rule as proposed.
Three commenters were in opposition to the rule.
The issues raised by the commenters were: (1) The perceived higher
cost of animal vaccinations resulting from the proposed rule; (2) the
inclusion of a provision to allow repackaging if each repackaged
product includes a complete copy of a package insert; (3) a question
whether the proposed rule provides an adequate remedy concerning the
problem of incorrect labeling; (4) the effect of the proposed rule on
the ability of consumers to vaccinate their own animals; (5) the impact
of the rule on veterinarians who dispense their own biologics; (6)
whether licensed veterinary biologics are in compliance with the U.S.
Department of Transportation's regulations; and (7) other issues
related to the proposed rule.
After the close of the comment period on June 28, 1993, APHIS
received a significant number of additional comment letters. These
additional comment letters were read, but since they were late, they
were not included as part of this rulemaking. The additional comments,
however, generally expressed opinions similar to those of commenters
who submitted letters before the close of the comment period.
Analysis of Comments and APHIS' Response
Thirty-six commenters were in agreement with the rule as proposed.
It was the general opinion of commenters supporting the rule that it
should be implemented in order to protect the health and safety of
animals and animal owners. They expressed the belief that unauthorized
repackaging and relabeling of licensed veterinary biologics contributes
to improper handling and storage of these products, which could render
them worthless and ineffective. Many also stated that unauthorized
repackaging and relabeling contributes to the improper administration
of vaccines and to the use of improper diluents resulting in liability
problems for the manufacturer of the original product. Additionally,
the commenters believe that manufacturers have a proprietary interest
in the packaging and labeling of their products and in the integrity of
the products that they manufacture, and that these interests are
compromised by unauthorized repackaging and relabeling.
Three commenters disagreed with the rule. Their comments are
discussed below.
1. The Increased Cost of Vaccinations Resulting From the Proposed Rule
One commenter stated that prohibiting repackaging would force pet
owners to seek vaccination from veterinarians and thus raise the cost
of vaccinations. Alternatively the increased cost would cause many pets
to go unvaccinated. In the commenter's opinion, the resulting increase
in unvaccinated pets would pose a much greater health risk than any
minute danger brought about by the possible mispackaging of ``home
administered vaccines.'' According to the commenter, the rule would
also restrict competition and threaten small businesses that repackage
non-prescription pet vaccines.
APHIS does not agree with these arguments in opposition to the
proposed rule. One purpose of the amendments is to clarify the intent
of the packaging and labeling provisions of the regulations which is to
regulate such activities in a comprehensive manner. Allowing the
repackaging and relabeling of products once they have left the licensed
establishment is not consistent with such intent. The rule will help to
eliminate the problem of improper or unauthorized packaging and
labeling after the product has left the producer's establishment. It
should be noted, however, that the rule does not prohibit over-the-
counter (OTC) sales of veterinary biologics. Pet owners may still
purchase vaccines for their own use, so long as they are packaged and
labeled according to regulations.
The rule makes it clear that persons who currently repackage
multiple vial cartons or containers for further sale would no longer be
able to do so. This does not mean that they could not continue to
operate as distributors or to sell single dose or individual products
for consumer use if such products were so packaged and labeled
according to regulations. As a matter of fact, APHIS has recently
approved a number of applications for such products. If there is any
additional cost to the consumer as a result of this rule, it is
outweighed by the risk to animal health posed by the improper packaging
and labeling of veterinary biological products after they have left the
licensed establishment. Therefore, no change is made to the regulations
in response to this commenter.
2. Commenter's Proposal to Allow Repackaging if Each Repackaged Product
Includes a Complete Copy of a Package Insert
A commenter proposed a compromise solution to allow repackaging if
every sale of a repackaged product includes a complete copy of a
package insert which contains complete product information and all
relevant data as to the method of administration.
APHIS does not agree with the proposed solution. Allowing
repackaging in this manner could cause a number of problems and would
raise many questions. For example, would the Agency need to issue a new
set of regulations to regulate repackagers in order to assure that
labeling and packaging inserts are consistent with regulations and that
the repackaging is adequately controlled and supervised to prevent
errors, and to assure that labels are legible? Would repackagers have
to be licensed, since packaging and labeling is included in the
regulatory definition of the term ``preparation''? How would the
integrity of the product be assured? And finally, who would bear the
responsibility in the event of damage caused by error or mislabeling?
As a matter of fact, just recently, the inclusion of wrong package
inserts with repackaged products has caused death and injury to dogs.
Considering these questions and the potential problems which could
arise, the most practical and logical solution concerning repackaging
is to issue the rule as proposed and to leave to the licensees the
option of producing and offering to the distributors individually
packaged or single dose products for resale.
APHIS explained in the preamble of the proposed rule that it would
prohibit the repackaging of final containers of product (either single
or multiple dose containers) packed in multiple container cartons if
the carton label or enclosure is required to complete the labeling for
the container (see 58 FR 25787, column 2, Docket No. 92-098-1, April
28, 1993). Therefore, APHIS proposed in Sec. 112.6(e) that biological
products in cartons or other containers shall not be removed from such
cartons or containers and repackaged for sale or distribution unless
each final container of product bears or is accompanied by complete and
approved labeling, which is affixed to or included with each final
container by the licensed establishment or producer of an imported
product.
This rule is intended to explicitly prohibit repackaging so that
mislabeling cannot occur. The final rule is slightly modified to
clarify the purpose of the provision.
Final containers of a product need not be packaged one per carton
when these products are distributed and sold in a multiple container
carton (see current Sec. 112.6(b)). When these products are distributed
and sold as individual final containers, however, such containers of a
product must be packaged and fully labeled in individual cartons with
the appropriate amount of diluent, if required, in order to be in
compliance with the regulations.
Section 112.1(a) of this rule requires that before they are removed
from a licensed establishment or offered for importation, biological
products must be packaged and labeled according to regulations. The
section further provides that packaging and labeling may only be
performed in a licensed establishment under an approved Outline of
Production. Therefore, the removal, from a multiple container carton,
of a final container of product for resale is prohibited. Labeling may
not be added or removed after the product has left the licensed
establishment or has been imported.
The effect of the final rule is to prohibit the unauthorized
repackaging and relabeling, for sale or distribution, of final
containers of veterinary biological products that are packaged in
multiple container cartons or other containers, and which do not bear a
complete, approved labeling affixed or included with each final
container by the licensed establishment producing the product. In the
case of imported products, a similar prohibition applies. In response
to a comment that imports should be included under the amendments,
proposed Sec. 112.6(e) is modified to provide for this. The
modification also makes the section consistent with Sec. 112.1(a).
In addition, we are making nonsubstantive changes in Sec. 112.6(e)
in order to clarify the fact that packaging and labeling should be an
integral part of product production and that final containers should
bear or be packaged, in a carton with, complete and approved labeling
which is affixed to or included with each container by the licensed
establishment or producer of an imported product. No other amendment to
the regulations is made in response to this commenter.
3. Whether the Proposed Rule Provides an Adequate Remedy to the Problem
of Incorrect Labeling
In response to the statement concerning enforcement under the
current regulations and the lack of an adequate remedy, APHIS notes
that the current regulations prohibit false and misleading labeling
and, although Sec. 112.5 provides for the review and approval of
labeling prior to use, it is not clear that repackaging and relabeling
after the products have left the licensed establishment is prohibited.
The explicit prohibition of repackaging and relabeling in this rule
directly addresses those activities after the product has left the
licensed establishment or has been imported and is intended to prevent
unapproved labeling.
The commenter was also concerned that the proposed rule would
unnecessarily restrict contract labeling. Labeling of licensed products
is required to be performed at licensed establishments. APHIS has not
allowed establishments to contract with others to apply labeling to
products (see 7 CFR 112.4(c)). This rule does not change this practice
and explicitly provides that all licensed products must be packaged and
labeled at licensed establishments or by the producer of an imported
product. This rule would not, however, prohibit the production of
biological products having a distributor's label.
4. The effect of the proposed rule on the ability of consumers to
vaccinate their own animals
A commenter indicated that the consumer should have the opportunity
to immunize his or her own animals. The rule does not deprive the
consumer of the option to immunize his or her own animals. As stated
previously, the rule does not prohibit OTC sales of veterinary
biologics. Animal owners will still be able to purchase single dose or
individual packages of vaccines that have been prepared in licensed
establishments in accordance with the regulations. Manufacturers may
continue to provide products for sale OTC, so long as the products
comply with the labeling and packaging requirements. Thus, the consumer
is still free to immunize his or her own animals. No change to the
regulations is made in response to this commenter.
5. The impact of the rule on veterinarians who dispense their own
biologics
Another commenter requested clarification of the impact of the rule
on products dispensed by a veterinarian.
It should be noted that the rule is not intended to interfere with
the practice of veterinary medicine. The practitioner may dispense
biological products under a veterinarian-client-patient relationship
(VCPR) as that term is described in Sec. 107.1 of the regulations.
Therefore, in response to the comments, proposed Sec. 112.6(e), is
modified to clarify its intended scope of coverage. Veterinarians
engaged solely in the mail order sale of veterinary biologics would not
meet the requirements that establish a valid VCPR exemption under 9 CFR
107.1.
6. Comments concerning Department of Transportation regulations
A commenter raised the issue of compliance with the regulations of
the U. S. Department of Transportation (DOT) pertaining to the shipment
of hazardous materials, including infectious agents.
In response to this commenter, APHIS notes that the DOT regulations
cited by the commenter provide a special exclusion for veterinary
biological products prepared according to regulations. These licensed
or permitted veterinary biological products are specifically exempted
from the requirements for the shipment of a hazardous substance (see
DOT regulations at 49 CFR 173.196(h)(2)). No change to the regulations
is made in response to this commenter.
7. Consumer responsibility for used syringes and needles
Several commenters stated that individual users of veterinary
biologics that require a syringe should be held responsible for the
proper disposal of syringes. We are making no changes based on these
comments, as the disposal of syringes is outside the scope of this
rule.
8. Other comments related to the proposed rule
One commenter stated that packaging and labeling requirements in
Sec. 112.1 should apply to any person, not just the licensee, making
changes to packaging and labeling. This is the intent of the rule. For
example, the preamble of the proposed rule (see 58 FR 25787, column 2,
Docket No. 92-098-1, April 28, 1993) stated that:
The regulations under proposed paragraphs (a) through (d) of
Sec. 112.1 would be applicable generally to any person and would not be
restricted to licensees.
No change to the regulations is made in response to this comment.
The commenter also stated that any changes to packaging or labeling
must be done by the licensed establishment and approved by APHIS. APHIS
agrees with this comment. In that regard, it should be noted that
Sec. 112.1(a) provides that packaging and labeling may only be
performed in a licensed establishment under an approved Outline of
Production or by the producer of an imported product. No change to the
regulations is made in response to this comment.
The commenter further stated that the rule should not apply to
certain products that are exempted by statute and thus not subject to
product licensure. APHIS agrees with this comment. This is true, since
products that are exempted by statute are not required to be made in a
licensed establishment, they are not subject to the provisions of this
rule. No change to the regulations is made in response to this
commenter.
It was the commenter's opinion that Secs. 112.1, 112.4, and 112.6
should not apply to the ultimate purchaser. APHIS also agrees with this
comment.
With reference to the heading of Sec. 112.5, the commenter
recommended that it should be changed from ``labeling'' to ``labels''.
APHIS does not agree with this comment. The term ``labeling'' under the
definitions of labeling terminology in 9 CFR 101.4(b) includes ``all
labels''. Thus the term ``labeling'' is retained in the title of
Sec. 112.5.
The commenter also stated that the regulations should not prohibit
the manufacture and sale of single dose licensed products. APHIS agrees
with this comment. APHIS notes that the final rule does not prohibit
the manufacture or sale of single dose or individual final containers
of licensed products. No change to the regulations has been made in
response to this comment.
The commenter concluded his comments with the statement that the
proposed amendments to 9 CFR 112 reflect a concern on the part of
licensed manufacturers that unauthorized repackaging and relabeling of
licensed products was tantamount to product tampering, which adversely
affects the integrity of such products and puts manufacturers at risk
of damage to their reputations as a consequence of such actions.
180-day transition period
In order to provide for a reasonable transition period before this
rule takes effect, we are making this rule effective 180 days after the
date of publication in the Federal Register. APHIS believes that this
transition period will allow needed time for manufacturers and
distributors that wish to prepare and distribute single-dose packages
of veterinary biologics to reach agreement and begin to implement the
manufacture and distribution of these products.
Other changes
In order to reflect organizational changes within APHIS, the
introductory paragraph of Sec. 112.5 is amended by removing the words
``Veterinary Services'' and adding the words ``Animal and Plant Health
Inspection Service'' in their place.
Based on the rationale set forth in the proposed rule and in this
document, we are adopting the provisions of the proposed rule as a
final rule, with the changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This final rule has been reviewed under Executive Order 12866. The
rule has been determined to be not significant for purposes of
Executive Order 12866, and, therefore has not been reviewed by the
Office of Management and Budget.
The rule prohibits the repackaging of veterinary biologics packaged
in multiple container cartons or other containers. Such repackaging can
result in the preparation, including labeling, of a veterinary
biological product in violation of the Act and regulations, and in the
removal or alteration of approved labeling, thereby compromising the
safety and efficacy of the biological product. In the absence of
approved labeling, the safe and effective use of the veterinary
biological product cannot be assured. This action benefits users in
that it helps ensure that users are provided with a product that is
properly labeled with approved directions, indications, and cautions
for use.
This action will provide greater assurance to consumers that
licensed veterinary biological products are prepared only with approved
labeling with adequate directions for use. The prohibition against
repackaging and relabeling outside of licensed facilities ensures that
cases involving unapproved labeling of biological products such as
those which resulted in the recent death and injury of dogs are avoided
in the future. APHIS believes that safety to animal health is best
assured by restricting to licensed facilities and producers of imported
products the preparation, which includes packaging and labeling, of
veterinary biological products.
Distributors who are currently in the business of breaking apart
multiple container cartons and repackaging and relabeling them for sale
as individual final containers of product are provided notice that
their actions will be in violation of the Act and regulations on the
effective date of this rule. Distributors may still purchase from
licensed manufacturers products that are already individually packaged
and labeled in accordance with part 112 rather than purchasing multiple
container cartons that must be broken apart and repackaged to provide a
single dose final container package for distribution. This action does
not prohibit the OTC distribution of products as long as the product is
produced in a licensed establishment under an approved Outline of
Production with approved labeling. Thus, persons currently repackaging
and distributing a licensed product can seek to have a licensee produce
a single dose or an individual container product for distribution. If
desired, such product may be labeled with a distributor label that
includes the name and address of the distributor. Based on information
available to APHIS, several licensed manufacturers already have
approved labeling to produce single dose veterinary biological
products.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12778
This final rule has been reviewed under Executive Order 12778,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are in conflict with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
This rule contains no new information collection or recordkeeping
requirements under the Paperwork Reduction Act of 1980 (44 U.S.C. 3501
et seq.).
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V).
List of Subjects in 9 CFR part 112
Animal biologics, Exports, Imports, Labeling, Packaging and
containers, Reporting and recordkeeping requirements.
Accordingly, 9 CFR part 112 is amended as follows:
PART 112--PACKAGING AND LABELING
1. The authority citation for 9 CFR part 112 continues to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).
2. Section 112.1 is revised to read as follows:
Sec. 112.1 General.
(a) Unless otherwise authorized or directed by the Administrator,
each biological product prepared at a licensed establishment, or
imported, shall be packaged and labeled as prescribed in this part
before it is removed from the licensed establishment or presented for
importation: Provided, That biological products to be imported for
research and evaluation shall be subject to packaging and labeling
requirements in Sec. 112.9. Provided further, That, unless otherwise
exempted, all preparation, including packaging and labeling, of
biological products shall only be performed in a licensed establishment
under an approved Outline of Production.
(b) No person shall apply or affix to or include with, or cause to
be applied or affixed to or included with, any carton or final
container of a biological product, any label, stamp, mark or statement
that is false or misleading in any particular, is not in compliance
with the regulations, or is not approved by APHIS.
(c) No person shall alter, mark or remove any approved labeling
affixed to or included with any biological product prior to selling or
otherwise distributing such product. In addition, no person shall mark
any carton, other container, or final container of a biological product
so as to falsify the labeling, make it misleading, or cause it to be
illegible.
(d) Labels that are stamped, printed or glued directly on cartons,
other containers, or final containers shall be legible throughout the
dating period. Biological products bearing labels, which have been
altered, mutilated, destroyed, obliterated or removed, shall be
withheld from the market.
3. In Sec. 112.4, the introductory paragraph is revised to read as
follows:
Sec. 112.4 Subsidiaries, divisions, distributors, and permittees.
Labels used by subsidiaries, divisions, distributors, and
permittees shall be affixed by the licensee in a licensed establishment
where the product is produced. Such labels shall comply with
requirements for their review, approval, and filing as provided in the
regulations.
* * * * *
4. In Sec. 112.5, the introductory paragraph, the words
``Veterinary Services'' are removed and the words ``Animal and Plant
Health Inspection Service'' are added in their place.
5. In Sec. 112.6, new paragraphs (e) and (f) are added to read as
follows:
Sec. 112.6 Packaging biological products.
* * * * *
(e) Final containers of biological product prepared at a licensed
establishment, or imported, in cartons or other containers shall not be
removed from such cartons or containers for sale or distribution,
unless each final container bears, or is packaged in a carton with,
complete and approved labeling which is affixed to or included with
each container by the licensed establishment producing the product or
by the producer in the case of imported product: Provided, That this
paragraph is not intended to apply to licensed veterinary practitioners
administering or dispensing biological products in the course of their
practice under a veterinary-client-patient-relationship as that term is
used in Sec. 107.1.
(f) Labels which are affixed to or included with a biological
product shall not be removed or altered in any manner.
Done in Washington, DC, this 17th day of August 1994.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 94-20640 Filed 8-23-94; 8:45 am]
BILLING CODE 3410-34-P
