[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