In navigating the intricacies of compliance with Board of Pharmacy regulations, individuals and entities find themselves needing to adapt to unique circumstances that may not align perfectly with existing rules. This is where the Variance Request form becomes an essential tool, offering a pathway to request exceptions from the standard regulatory requirements. Intent on safeguarding public health, safety, and well-being, the form outlines a clear process for submitting variance requests, detailing the necessary information such as the specific rule in question, the justification for the variance, alternative measures proposed, and the desired duration of the variance. The Board of Pharmacy carefully evaluates each request to ensure that any granted variance will not compromise public safety and that the proposed alternatives are at least as effective as the original requirements. In doing so, the board maintains a balance between regulatory compliance and the flexibility to address specific needs. Applicants are informed of the board's decision within a specified timeframe, along with any conditions attached to an approved variance. The process also accommodates the renewal of variances, provided the criteria continue to be met, and extends to pharmacists seeking approval for research projects that may not fit within current regulations. As such, the Variance Request form serves as a critical bridge between rigid regulatory frameworks and the dynamic, real-world scenarios faced by those in the pharmacy sector.
| Question | Answer |
|---|---|
| Form Name | Variance Request Form |
| Form Length | 1 pages |
| Fillable? | Yes |
| Fillable fields | 33 |
| Avg. time to fill out | 6 min 51 sec |
| Other names | mn board pharmacy variance request, request for building variance nicollet county mn, mn board of pharmacy variance form, Pharmacists |
VARIANCE REQUEST FORM
BOARD OF PHARMACY RULE 6800.9900 VARIANCES
Subpart 1. Right to request variance. A person subject to the rules of the Board of Pharmacy may request that the board grant a variance from any rule of the Board of Pharmacy.
Subp. 2. Submission and contents of request. A request for a variance must be submitted to the board in writing. Each request must contain the following information:
A.the specific rule for which the variance is requested;
B.the reason for the request;
C.the alternative measures that will be taken if a variance is granted;
D.the length of time for which a variance is requested; and
E.any other relevant information necessary to properly evaluate the request for the variance.
Subp. 3. Decision on variance. The board shall grant a variance if it determines that:
A.the variance will not adversely affect directly or indirectly, the health, safety, or
B.the alternative measures to be taken, if any, are equivalent or superior to those prescribed in the part for which the variance is requested; and
C.compliance with the part for which the variance is requested would impose an undue burden upon the applicant.
The board shall deny, revoke, or refuse to renew a variance if the board determines that item A, B, or C has not been met.
Subp. 4. Notification. The board shall notify the applicant in writing within 60 days of the board's decision. If a variance is granted, the notification shall specify the period of time for which the variance will be effective and the alternative measures or conditions, if any, to be met by the applicant.
Subp. 5. Renewal. Any request for the renewal of a variance shall be submitted in writing prior to the expiration date of the existing waiver. Renewal requests shall contain the information specified in subpart 2. A variance shall be renewed by the board if the applicant continues to satisfy the criteria contained in subpart 3 and demonstrates compliance with the alternative measures or conditions imposed at the time the original variance was granted.
Subp. 6. Research projects. Pharmacists desiring to participate in research or studies not presently allowed by or addressed by rules of the board may apply for approval of the projects through waivers or variances in accordance with subparts 1 to 4.
PERSON SUBJECT TO THE RULES OF THE BOARD OF PHARMACY REQUESTING THIS VARIANCE
NAME: ____________________________________________________________________ LICENSE #:___________________________
LIST THE SPECIFIC RULE(S) FOR WHICH THE VARIANCE IS REQUESTED: 6800:___________________6800:_________________
LIST THE NAME AND LICENSE NUMBER OF THE SITE(S) AFFECTED
NAME___________________________________LICENSE #__________NAME____________________________LICENSE#__________
ADDRESS ___________________________________________________ADDRESS ___________________________________________
STATE THE REASON FOR THIS REQUEST: (It is required that the variance request result in equivalent or improved public safety and in equivalent or improved patient outcomes) _______________________________________________________________________________
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
POLICIES AND PROCEDURES DEVELOPED TO IMPLEMENT THE VARIANCE REQUEST: (Please attach if more space is needed)
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
QUALITY ASSURANCE / QUALITY IMPROVEMENT: PLEASE DESCRIBE THE METHODOLOGY AND STANDARDS FOR MONITORING OUTCOMES. (Please attach if more space is needed) ________________________________________________________
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
FOR WHAT LENGTH OF TIME IS THIS VARIANCE REQUESTED? |
|
||
___ 3 MONTHS |
___ 6 MONTHS |
___ 12 MONTHS |
___ OTHER, PLEASE LIST _________________ |
OTHER RELEVANT INFORMATION THE BOARD OF PHARMACY SHOULD CONSIDER ALONG WITH THIS REQUEST:
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
SIGNATURE: ______________________________________________________________________ DATE:________________________