4729-9-28 Licensure as a virtual wholesale distributor/broker.  

  • Text Box: ACTION: Withdraw Proposed Text Box: DATE: 08/23/2016 9:07 AM

     

     

     

    Rule Summary and Fiscal Analysis (Part A)

     

    State Board of Pharmacy

    Agency Name

     

    Cameron McNamee

    Division                                                                  Contact

     

    77 South High Street Room 1702 Columbus OH 43215-6126

    614-466-7322

    Agency Mailing Address (Plus Zip)                                       Phone                     Fax

    cameron.mcnamee@bop.ohio.gov

    Email

    4729-9-28

    Rule Number

    AMENDMENT

    TYPE of rule filing

    Rule Title/Tag Line              Licensure as a virtual wholesale distributor/broker.

    RULE SUMMARY

    1.  Is the rule being filed for five year review (FYR)? No

    2.  Are you proposing this rule as a result of recent legislation? No

    3.  Statute prescribing the procedure in accordance with the agency is required to adopt the rule: 119.03

    4.  Statute(s) authorizing agency to adopt the rule: 3719.28, 4729.26

    5.  Statute(s) the rule, as filed, amplifies or implements: 3719.03, 4729.53

    6.  State the reason(s) for proposing (i.e., why are you filing,) this rule:

    The rules proposed under this statutory authority are necessary to facilitate compliance with the provisions in Chapters 4729 and 3719 of the Ohio Revised Code to promote the public's safety. Without this regulation, the Ohio State Board of Pharmacy would not be able to ensure proper oversight of businesses operating as virtual wholesalers.

    7.  If the rule is an AMENDMENT, then summarize the changes and the content

    of the proposed rule; If the rule type is RESCISSION, NEW or NO CHANGE, then summarize the content of the rule:

    Removes the requirement that virtual wholesalers provide proof of registration with the U.S. Drug Enforcement Administration, as DEA does not register virtual wholesalers. The rule also clarifies that all background checks consist of BCI/FBI criminal records checks.

    8.  If the rule incorporates a text or other material by reference and the agency claims the incorporation by reference is exempt from compliance with sections

    121.71 to 121.74 of the Revised Code because the text or other material is generally available to persons who reasonably can be expected to be affected by the rule, provide an explanation of how the text or other material is generally available to those persons:

    This rule references the Ohio Revised Code and the Ohio Administrative Code. The

    O.R.C. and O.A.C. are generally available in libraries and on the internet to persons who reasonably can be expected to be affected by the rule.

    This rule references the United States Code (U.S.C). The U.S.C. is generally available in libraries and on the internet to persons who reasonably can be expected to be affected by the rule.

    9.  If the rule incorporates a text or other material by reference, and it was infeasible for the agency to file the text or other material electronically, provide an explanation of why filing the text or other material electronically was infeasible:

    Ohio Revised Code Sections 121.75 and 121.76 exempts these texts from inclusion in this filing.

    10.  If the rule is being rescinded and incorporates a text or other material by reference, and it was infeasible for the agency to file the text or other material, provide an explanation of why filing the text or other material was infeasible:

    Not Applicable.

    11.  If revising or refiling this rule, identify changes made from the previously filed version of this rule; if none, please state so. If applicable, indicate each specific paragraph of the rule that has been modified:

    Not Applicable.

    12.  Five Year Review (FYR) Date: 4/1/2021

    (If the rule is not exempt and you answered NO to question No. 1, provide the scheduled review date. If you answered YES to No. 1, the review date for this rule is the filing date.)

    NOTE: If the rule is not exempt at the time of final filing, two dates are required: the current review date plus a date not to exceed 5 years from the effective date for Amended rules or a date not to exceed 5 years from the review date for No Change rules.

    FISCAL ANALYSIS

    13.  Estimate the total amount by which this proposed rule would increase / decrease either revenues / expenditures for the agency during the current biennium (in dollars): Explain the net impact of the proposed changes to the budget of your agency/department.

    This will have no impact on revenues or expenditures.

    $0.00

    No net impact.

    14.  Identify the appropriation (by line item etc.) that authorizes each expenditure necessitated by the proposed rule:

    Not applicable.

    15.  Provide a summary of the estimated cost of compliance with the rule to all directly affected persons. When appropriate, please include the source for your information/estimated costs, e.g. industry, CFR, internal/agency:

    Clarifies that virtual wholesalers are not required to have a drug enforcement administration license. This amended rule language should not have any adverse impact on a virtual wholesaler.

    16.  Does this rule have a fiscal effect on school districts, counties, townships, or municipal corporations? No

    17.  Does this rule deal with environmental protection or contain a component dealing with environmental protection as defined in R. C. 121.39? No

    S.B. 2 (129th General Assembly) Questions

    18.  Has this rule been filed with the Common Sense Initiative Office pursuant to

    R.C. 121.82? Yes

    19.  Specific to this rule, answer the following:

    A.) Does this rule require a license, permit, or any other prior authorization to engage in or operate a line of business? Yes

    Requires license as a wholesale distributor of dangerous drugs.

    B.) Does this rule impose a criminal penalty, a civil penalty, or another sanction, or create a cause of action, for failure to comply with its terms? Yes

    Violation of this rule may result in administrative licensure discipline for a pharmacist, pharmacy intern and terminal/wholesale distributors of dangerous drugs. Discipline might include reprimand, suspension of a license, required course work (pharmacists/interns), monetary fine and/or revocation of a license.

    C.) Does this rule require specific expenditures or the report of information as a condition of compliance? Yes

    Requires information to be submitted as part of licensure process as well as background checks.