SS 093-18

450.02 (3) (e) The Board may promulgate rules establishing minimum standards for the practice of pharmacy.

5. Estimate of amount of time that state employees will spend developing the rule and of other resources necessary to develop the rule:

100 hours

6. List with description of all entities that may be affected by the proposed rule:

Pharmacies and pharmacists.

7. 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 only portion of the proposed rule which also relates to federal regulations is the storage of controlled substances.

Title 21 CFR 1301

§1301.75 Physical security controls for practitioners.

(a) Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.

(b) Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances.

(c) Sealed mail-back packages and inner liners collected in accordance with part 1317 of this chapter shall only be stored at the registered location in a securely locked, substantially constructed cabinet or a securely locked room with controlled access, except as authorized by §1317.80(d).

(d) This section shall also apply to nonpractitioners authorized to conduct research or chemical analysis under another registration.

(e) Thiafentanil, carfentanil, etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.

8. Anticipated economic impact of implementing the rule (note if the rule is likely to have a significant economic impact on small businesses):

None to minimal. It is not likely to have a significant economic impact on small businesses.

Contact Person: Sharon Henes, Administrative Rules Coordinator, [phone]

         

Authorized Signature

  June 28, 2018      

Date Submitted