For example, the proposed rules provide definitions of such undefined statutory terms as “firearms safety or training course" and “national or state organization that certifies firearms instructors." Such definitions are necessary to give substantive content to these otherwise undefined statutory terms so as to carry out the legislative purposes of ensuring that all licensees have been trained in firearms and firearms safety and of ensuring that all certified firearms instructors have demonstrated the ability and knowledge required for providing training in firearms and firearms safety. The policy alternative of not defining such terms in DOJ's administrative rules would be contrary to those important legislative purposes.
Similarly, the proposed rules specify the types of information that must be included in a training certificate or affidavit in order for DOJ to find that certificate or affidavit to be sufficient to satisfy the training documentation requirements in s.
175.60 (4) (a), Stats. Such specification is necessary to give substantive content to the statutory documentation requirements so as to carry out the legislative purpose of ensuring that every successful applicant for a concealed carry license has adequately demonstrated completion of at least one of the forms of statutorily required training. The policy alternative of not specifying the required contents of an acceptable training certificate or affidavit in DOJ's administrative rules would be contrary to that important legislative purpose.
Likewise, the proposed rule designating those states other than Wisconsin that conduct a background check for concealed carry licensees comparable to Wisconsin's background check is necessary to comply with the statutory requirement of s.
165.25 (12m), Stats. That rule enables law enforcement officers and others to determine whether a particular concealed carry license issued by another state is entitled to recognition as an “out-of-state license" as defined in s.
175.60 (1) (f), Stats. The alternative of not promulgating such a rule would violate the requirements of s.
165.25 (12m), Stats. and would be contrary to the purpose of facilitating recognition of out-of-state licenses.
The proposed rules also contain procedures for issuing a new concealed carry license or certification card to an individual who changes his or her name, and procedures under which DOJ will work cooperatively with courts and law enforcement agencies in relation to any emergency concealed carry license that may be issued by a court, pursuant to s.
175.60 (9r). These procedures are not specifically required by statute but are necessary to carry out the legislative purposes of ensuring that licenses and certification cards are issued only to eligible individuals and that all applicants and licensees are properly identified at all times. The policy alternative of not including such procedures in DOJ's administrative rules would be contrary to those important legislative purposes.
Statutory Authority for the Rule (Including the Statutory Citation and Language)
Those portions of the proposed rules that establish the amount of the fee to be charged for a concealed carry license are expressly and specifically authorized and required by s.
175.60 (7), Stats., which provides:
SUBMISSION OF APPLICATION. An individual may apply for a license under this section with the department by submitting, by mail or other means made available by the department, to the department all of the following:
…
(c) A license fee in an amount, as determined by the department by rule, that is equal to the cost of issuing the license but does not exceed $37. The department shall determine the costs of issuing a license by using a 5-year planning period.
Those portions of the proposed rules that establish procedures for the administrative review by DOJ of any denial, suspension, or revocation of a license are expressly and specifically authorized by s.
175.60 (14g), Stats., which provides:
DEPARTMENTAL REVIEW. The department shall promulgate rules providing for the review of any action by the department denying an application for, or suspending or revoking, a license under this section.
Those portions of the proposed rules that establish the amount of the fee to be charged for the renewal of a concealed carry license are expressly and specifically authorized by s.
175.60 (15) (b), Stats., which provides:
The department shall renew the license if, no later than 90 days after the expiration date of the license, the licensee does all of the following:
…
4. Pays all of the following:
a. A renewal fee in an amount, as determined by the department by rule, that is equal to the cost of renewing the license but does not exceed $12. The department shall determine the costs of renewing a license by using a 5-year planning period.
Those portions of the proposed rules that are not specifically authorized by ss.
175.60 (7),
(14g), and
(15) (b), Stats., as described above, are authorized by s.
227.11 (2) (a), Stats., which provides:
(2) Rule-making authority is expressly conferred as follows:
(a) Each agency may promulgate rules interpreting the provisions of any statute enforced or administered by the agency, if the agency considers it necessary to effectuate the purpose of the statute, but a rule is not valid if the rule exceeds the bounds of correct interpretation. All of the following apply to the promulgation of a rule interpreting the provisions of a statute enforced or administered by an agency:
1. A statutory or nonstatutory provision containing a statement or declaration of legislative intent, purpose, findings, or policy does not confer rule-making authority on the agency or augment the agency's rule-making authority beyond the rule-making authority that is explicitly conferred on the agency by the legislature.
2. A statutory provision describing the agency's general powers or duties does not confer rule-making authority on the agency or augment the agency's rule-making authority beyond the rule-making authority that is explicitly conferred on the agency by the legislature.
3. A statutory provision containing a specific standard, requirement, or threshold does not confer on the agency the authority to promulgate, enforce, or administer a rule that contains a standard, requirement, or threshold that is more restrictive than the standard, requirement, or threshold contained in the statutory provision.
This statute expressly confers on DOJ the general power to determine whether administrative rules interpreting those statutory provisions in Act 35 that are to be enforced or administered by DOJ are necessary to effectuate the purpose of those statutory provisions and, if such necessity is found, to promulgate such administrative rules, as long as those rules do not exceed the bounds of correct interpretation of the governing statutes.
DOJ finds that the rules here proposed are necessary to effectuate those portions of ss.
175.49 and
175.60, Stats., that require DOJ to establish and operate procedures governing:
• the issuance of concealed carry licenses to qualified applicants, including verification that each applicant has satisfied the applicable statutory training requirements, has passed the mandatory background check, and has met all of the other statutory eligibility requirements for a license;
• the issuance of concealed carry certification cards to qualified former federal law enforcement officers residing in Wisconsin, including verification that each applicant has satisfied the applicable firearm certification requirements, has passed the mandatory background check, and has met all of the other statutory eligibility requirements for certification;
• the administration of concealed carry licenses and certifications that have been issued by DOJ, including the maintenance and treatment of records; the receipt and processing of information from courts about individuals subject to a court-imposed disqualification from possessing a dangerous weapon; the renewal of licenses and certifications and the replacement of those that are lost, stolen, or destroyed; the processing of address changes or name changes for licenses and certifications; procedures and standards for revoking or suspending a license or certification; procedures for the administrative review by DOJ of any denial, suspension, or revocation of a license or certification; and procedures governing DOJ's cooperation with courts and law enforcement agencies in relation to emergency licenses issued by a court; and
• the qualification and certification of firearms instructors by DOJ and the identification of those firearm instructors who are certified by a national or state organization.
DOJ further finds that the rules here proposed:
• do not exceed the bounds of correct interpretation of ss.
175.49 or
175.60, Stats.;
• are authorized by the statutes described above and are not based on authority derived from any other statutory or nonstatutory statements or declarations of legislative intent, purpose, findings, or policy;
• are authorized as necessary interpretations of the specific requirements of ss.
175.49 and
175.60, Stats., and are not based on authority derived from any other general powers or duties of DOJ; and
• do not impose any standards or requirements that are more restrictive than the standards and requirements contained in ss.
175.49 and
175.60, Stats.
The rules proposed here may be promulgated as emergency rules under s.
227.24 (1) (a), Stats., which provides:
An agency may promulgate a rule as an emergency rule without complying with the notice, hearing and publication requirements under this chapter if preservation of the public peace, health, safety or welfare necessitates putting the rule into effect prior to the time it would take effect if the agency complied with the procedures.
DOJ finds that the public welfare necessitates promulgating the proposed rules as emergency rules under s.
227.24 (1) (a), Stats. For the reasons already described in Section 1 above, in order to ensure continuity and avoid confusion and disruption in the operation of the concealed carry licensing program, it is necessary that DOJ have emergency rules continuously in effect until the permanent rulemaking process is completed. The preservation of such continuity and the avoidance of such confusion and disruption is plainly in the public interest. The public welfare thus necessitates that the proposed rules be promulgated as emergency rules under s.
227.24, Stats. While these emergency rules are in effect, DOJ will complete the permanent rulemaking process that is under way.
Estimate of the Amount of Time that State Employees Will Spend to Develop the Rule And of Other Resources Necessary to Develop the Rule
It is estimated that state employees will spend approximately 10 hours on the rulemaking process for the emergency rules proposed here, primarily for compliance with required rulemaking procedures.
Description of All Entities that May Be Impacted by the Rule
The proposed rules governing procedures and standards for the issuance and administration of concealed carry licenses under s.
175.60, Stats., directly affect the interests of all Wisconsin residents who wish to apply for a license to carry a concealed weapon. In addition, the proposed rules also indirectly affect the interest of the general public to the extent that the proper training and licensing of concealed carry licensees generally affects public safety.
The proposed rules governing procedures and standards for the issuance and administration of certification cards under s.
175.49 (3), Stats., directly affect the interests of all former federal law enforcement officers residing in Wisconsin who wish to apply for such certification. In addition, the proposed rules also indirectly affect the interest of the general public to the extent that the proper firearm certification of former law enforcement officers generally affects public safety.
The proposed rules governing the procedures and standards for the qualification and certification of firearms instructors by DOJ under s.
175.60 (4) (b), Stats., directly affect the interests of all eligible persons who wish to apply for such certification. The proposed rules identifying those firearm instructors who are certified by a national or state organization, as provided in s.
175.60 (4) (a), Stats., directly affect the interests of all persons who wish to claim such certification as a basis for providing training in firearms and firearm safety under that statute. In addition, the proposed rules also indirectly affect the interest of the general public to the extent that the proper certification of firearms instructors generally affects public safety.
Summary and Preliminary Comparison of Any Existing or Proposed Federal Regulation that Is Intended to Address the Activities To Be Regulated by the Rule
For persons other than current and former law enforcement officers, the regulation of the carrying of concealed weapons is primarily governed at the state level. Numerous federal statutes and regulations restrict the possession of weapons that have been shipped in interstate commerce, but there are no federal regulations that relate to the licensing of concealed carry by such persons, nor are there federal regulations governing the certification of firearms instructors for concealed carry purposes.
For qualified current and former law enforcement officers, state and local laws restricting the carrying of concealed firearms are federally preempted by 18 U.S.C. ss. 926B-926C (commonly referred to as “H.R. 218"). The provisions in
2011 Wis. Act 35 related to qualified current and former law enforcement officers are state-law codifications of the corresponding provisions in H.R. 218. Similarly, the rules proposed here governing procedures and standards for the issuance and administration of concealed carry certification cards for qualified former federal law enforcement officers also codify corresponding provisions in the federal law.
Contact Person
Assistant Attorney General Thomas C. Bellavia, (608) 266-8690.
Safety and Professional Services —
Pharmacy Examining Board
This statement of scope was approved by the governor on October 16, 2012.
Rule No.
Relating to
Sterile Pharmaceuticals and Non-Sterile Pharmaceuticals.
Rule Type
Permanent. (Revision)
Finding/Nature of Emergency (Emergency Rule Only):
N/A.
Detailed Description of the Objective of the Proposed Rule
The Wisconsin Pharmacy Examining Board seeks to repeal this rule in its entirety, and to replace it with references to the United States Pharmacopeia (USP) chapters 795 (Pharmaceutical Compounding – Non-Sterile Preparations) and 797 (Pharmaceutical Compounding – Sterile Preparations).
Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
The Board seeks to repeal this rule in its entirety and replace it with references to specific USP chapters related to standards for non-sterile compounding and sterile compounding because Ch.
Phar 15, as it currently exists, is an outdated model for sterile pharmaceuticals. Moreover, the board currently does not have any rules which specifically reference the standards to which non-sterile compounding must occur. In order to best protect the public, the board seeks to provide specific references to USP standards pertaining to both sterile and non-sterile compounding. The board concludes that the proposed rule should cover both sterile and non-sterile compounding in a concise manner that is similar to Minnesota's pharmacy rule under Minn. R. 6800.3300 (2011).
Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section
450.02 (3) (a), Stats., authorizes the board to promulgate rules “[r]elating to the manufacture of drugs and the distribution and dispensing of prescription drugs." Moreover, s.
450.02 (3) (e) authorizes the board to promulgate rules “[e]stablishing the minimum standards for the practice of pharmacy." The “practice of pharmacy" is defined under s.
450.01 (16) (b), Stats., to include the “[c]ompounding, packaging, labeling, dispensing, and the coincident distribution of drugs and devices." Under s.
450.01 (3), Stats., “'[c]ompound' means to mix, combine or put together various ingredients or drugs for the purpose of dispensing."
Section
15.08 (5) (b), Stats., allows each examining board to “promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession."
Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
40 hours.
List with Description of All Entities that May Be Affected by the Proposed Rule
Pharmacies and pharmacists.
Summary and Preliminary Comparison with Any Existing or Proposed Federal Regulation that Is Intended to Address the Activities to be Regulated by the Proposed Rule
The United States Pharmacopeia and The National Formulary (USP–NF) is a book of public pharmacopeial standards. It contains standards for chemical and biological drug substances, dosage forms, and compounded preparations. These standards have been recognized in the U.S. Federal Food, Drug and Cosmetic Act since it was first enacted in 1938. The U.S. Federal Food, Drug, and Cosmetics Act designates the USP–NF as official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding.
USP standards are recognized in a variety of U.S. federal legislation. The USP's drug standards are referenced throughout the provisions of the Federal Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. ss. 351 – 360 (2010). As it relates to compounding, federal law requires a licensed pharmacist to comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding. 21 U.S.C. s. 353(b)(1)(A)(i)(I) (2010).
Anticipated Economic Impact of Implementing the Rule (Note If the Rule Is Likely To Have a Significant Economic Impact on Small Businesses)
This rule may have a significant economic impact on small business that choose to compound or provide sterile pharmaceuticals.
Contact Person
Sharon Henes, Paralegal, (608) 261-2377.
Safety and Professional Services —
Psychology Examining Board
This statement of scope was approved by the governor on October 18, 2012.
