[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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