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Phar 15, as it currently exists, is an outdated model for sterile pharmaceuticals.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.
Rule No.
Relating to
Applicant appearance.
Rule Type
Permanent. (Revision)
Finding/Nature of Emergency (Emergency Rule Only)
N/A.
Detailed Description of the Objective of the Proposed Rule
Per s.
455.04 (5), Stats., Applicants for licensure
may be required to appear before the examining board in person prior to licensure. However, s.
Psy 2.09 (4) requires
every applicant to appear before the board in person prior to licensure as a psychologist. (
emphasis added) (Note: The board's rule governing licensure for a private practice of school psychologist retains the discretionary word “may".)
The board intends the rule to reflect the statute which is permissive rather than being more restrictive than the statute. This change will streamline the application process by not requiring every applicant to make an appearance before the board in order to be licensed.
This change would also require a change to s.
Psy 2.12 (2). Under the existing rule, applicants who are licensed in another state which is signatory to the agreement of reciprocity of the Association of State and Provincial Psychology Boards are deemed to meet several of the application requirements.
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 existing policy requires every applicant to make an appearance before the board prior to licensing even though the statute provision for an appearance is discretionary.
This proposed rule will reduce the administrative burden of the resources of the Psychology Examining Board and the Department of Safety and Professional Services. In addition it would significantly reduce the time it takes an applicant to become licensed because they would no longer have to wait until a scheduled meeting.
This change would also necessitate a change to s.
Psy 2.12 (2) which allows applicants licensed in a state which is signatory to the agreement of reciprocity of the Association of State and Provincial Psychology Boards to be recognized as meeting several of the application requirements. The reciprocity agreement requires an appearance before the Board as part of the licensure process. Over the years, many states have decided to no longer participate in the agreement of reciprocity. Currently there are only seven other signatory states (Arkansas, Kentucky, Missouri, Nebraska, Nevada, Oklahoma and Texas) who are participating in the reciprocity agreement. None of these states are neighboring states, therefore the change would not have a significant impact.
The alternative to changing the rule to allow the appearance to be discretionary would be to continue requiring every applicant to appear before the board.
Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section
15.08 (5) (b), Stats. Each examining board shall 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.
Section
455.08, Stats. The examining board shall adopt such rules as are necessary under this chapter.
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
Applicants for licensure.
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
There is no federal regulation that is intended to address the activities to be regulated by the proposed rule.
Anticipated Economic Impact of Implementing the Rule (Note If the Rule Is Likely To Have a Significant Economic Impact on Small Businesses)
No or minimal economic impact. It is not likely to have an economic impact on small business.
Contact Person
Sharon Henes, Paralegal, Division of Board Services, (608) 261-2377.
Safety and Professional Services —
Psychology Examining Board
The statement of scope was approved by the governor on October 18, 2012.
Rule No.
Relating to
Continuing education.
Rule Type
Permanent. (Revision)
Finding/Nature of Emergency (Emergency Rule Only)
N/A.
Detailed Description of the Objective of the Proposed Rule
Sections
455.065 (1) and
(3), Stats., state the examining board shall promulgate rules establishing the minimum number of hours of continuing education, topic areas that the continuing education must cover, the criteria for the approval of continuing education programs and courses required for renewal of a license and the criteria for the approval of the sponsors and cosponsors of those continuing education programs and courses.
Section
Psy 4.02 provides that the board may require not more than 20 of the 40 continuing education hours in each biennial registration period be acquired within specified topic areas. However, the current rule does not state the topic areas. This proposed rule would specify the topic areas.
In addition this proposed rule would update s.
Psy 4.02 to reflect current continuing education programs, including technological methods of delivery, and to streamline the approval process for the continuing education program and courses.
Description of the Existing Policies Relevant to the Rule, New Policies Proposed To Be Included in the Rule, and an Analysis of Policy Alternatives
Currently the topic areas are not specified in the rule and licensees are confused as to which topic areas, if any, must be addressed by their continuing education. This confusion is evidenced in the recent continuing education audits. Clarification of the topic areas will streamline the process. By reviewing and updating the continuing education requirements we are providing the licensees with more continuing education opportunities.
An alternative is not to change the rule. This would not provide the necessary clarity to the licensees as to what exactly are the required topic areas for continuing education. By not changing the rule, the rule will not be in conformity with the statutory requirement.
Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section
15.08 (5) (b), Stats. Each examining board shall 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.
Section
455.065 (1), Stats. The examining board shall promulgate rules establishing the minimum number of hours of continuing education, the topic areas that the continuing education must cover, the criteria for the approval of continuing education programs and courses required for renewal of a license and the criteria for the approval of the sponsors and cosponsors of those continuing education programs and courses.
Section
455.065 (3), Stats. The examining board shall promulgate rules establishing the minimum number of hours of continuing education, the topic areas that the continuing education must cover, the criteria for the approval of continuing education programs and courses required for the exemptions from the examination requirements under s.
455.04 (1) (e) and
(4) (f), Stats.
, and the criteria for the approval of the sponsors and cosponsors of those continuing education programs and courses.
Section
455.08, Stats. The examining board shall adopt such rules as are necessary under this chapter.
Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary To Develop the Rule
60 hours.
List with Description of All Entities that May Be Affected by the Proposed Rule
Licensed psychologists and private practice school psychologists.
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
