| Notice Filed with SOS |
06/12/2018 |
| Rule |
ProposedRuleAttach2018-00253.rtf |
| Additional Information |
AddInfoAttach2018-00253.pdf |
| Statutory Authority |
Sections 12-42.5-101, 12-42.5-105, 12-42.5-106 (3), and 24-4-103, C.R.S. |
| Description of Subjects/Issues |
Rule 3.05.00 details prescribing of OTC drugs. Changes to Rule 5.01.31 specify transcription of recorded orders and allows, with conditions, a computer terminal outside the compounding / dispensing area. Changes to Rule 5.01.40 and 5.01.50 address the hours and security for pharmacies in certain situations. Changes to Rule 11.03.05 requires a perpetual C-II inventory in pharmacies. Changes to Rule 11.04.10 specify the conditions for electronic maintenance of C-II orders. Changes to Rule 11.06.00 eliminate the need to maintain a DEA 222 Form when ordering the drugs via the DEA’s CSOS system. Changes to Rule 14.02.30 require controlled substance inventories when the consultant pharmacist visits an Other Outlet. Changes to Rule 20.00.90 and 20.01.00 allow a fulfillment pharmacy to deliver a prescription directly to the patient. Changes to Rule 21.00.20 clarify the requirements of nonresident pharmacies who wish to distribute compounded veterinary prescription drugs into Colorado. Changes to Rule 21.20.70 clarify the use of velocity flow meters under certain conditions. Changes to Rule 25.00.12 eliminate the requirement of a preregistration inspection of a specialized prescription drug outlet. Changes to Rule 25.00.14 address the packaging and labeling of medication for a specific patient by an automated device at a specialized prescription drug outlet. Changes to Rule 25.00.16 require annual inventories of controlled substances in specialized prescription drug outlets. |
| Purpose/Objective of Rule |
Rule 3.05.00 details prescribing of OTC drugs. Changes to Rule 5.01.31 specify
transcription of recorded orders and allows, with conditions, a computer terminal
outside the compounding / dispensing area. Changes to Rule 5.01.40 and 5.01.50
address the hours and security for pharmacies in certain situations. Changes to
Rule 11.03.05 requires a perpetual C-II inventory in pharmacies. Changes to Rule
11.04.10 specify the conditions for electronic maintenance of C-II orders. Changes
to Rule 11.06.00 eliminate the need to maintain a DEA 222 Form when ordering
the drugs via the DEA’s CSOS system. Changes to Rule 14.02.30 require
controlled substance inventories when the consultant pharmacist visits an Other
Outlet. Changes to Rule 20.00.90 and 20.01.00 allow a fulfillment pharmacy to
deliver a prescription directly to the patient. Changes to Rule 21.00.20 clarify the
requirements of nonresident pharmacies who wish to distribute compounded
veterinary prescription drugs into Colorado. Changes to Rule 21.20.70 clarify the
use of velocity flow meters under certain conditions. Changes to Rule 25.00.12
eliminate the requirement of a preregistration inspection of a specialized
prescription drug outlet. Changes to Rule 25.00.14 address the packaging and
labeling of medication for a specific patient by an automated device at a
specialized prescription drug outlet. Changes to Rule 25.00.16 require annual
inventories of controlled substances in specialized prescription drug outlets. |
| Basis And Purpose |
BasisAndPurposeAttachment2018-00253.pdf
|
| Regulatory analysis |
RegulatoryAnalysisAttachment2018-00253.pdf
|
| Submitted in response to issues raised by COLS/OLLS? |
No
|
| Is this rule adopted in response to recent legislation? |
No
|
| Hearing Date |
07/19/2018 |
| Hearing Time |
09:30 AM |
| Hearing Location |
1560 Broadway, Ste. 110D |
| Contact Name |
Joseph Libre |
| Contact Title |
Interim Program Director |
| Contact Telephone |
303-894-7754 |
| Contact email |
joseph.liber@state.co.us |