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The Oregon Administrative Rules contain OARs filed through September 15, 2014
 
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BOARD OF PHARMACY

 

DIVISION 1

PROCEDURAL RULES

855-001-0000

Notice of Proposed Rule

Prior to the permanent adoption, amendment, or repeal of any rule, the State Board of Pharmacy shall give notice of its intended action as required in ORS 183.335(1):

(1) In a manner established by rule adopted by the Board under ORS183.341(4), which provides a reasonable opportunity for interested persons to be notified of the agency's proposed action;

(2) In the bulletin referred to in ORS 183.360 at least 21 days prior to the effective date;

(3) To persons who have requested notice pursuant to ORS183.335(8) at least 28 days before the effective date; and

(4) To persons specified in ORS 183.335(15) at least 49 days before the effective date; and

(5) To persons or organizations the Board's Executive Director determines, pursuant to ORS 183.335, are interested persons in the subject matter of the proposed rule, or would be likely to notify interested persons of the proposal; and

(a) Oregon State Pharmacist Association;

(b) Oregon Society of Health System Pharmacists;

(6) To the Associated Press and the Capitol Press Room.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 183.335
Hist.: 1PB 42, f. & ef. 4-6-76; 1PB 54, f. & ef. 12-13-77; 1PB 1-1978, f. & ef. 2-21-78; 1PB 7-1978(Temp), f. & ef. 7-1-78; 1PB 9-1978, f. & ef. 10-23-78; BP 1-2001, f. & cert. ef. 3-5-01; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; BP 1-2005, f. & cert. ef. 2-7-05; BP 1-2007, f. & cert. ef. 6-29-07

855-001-0005

Model Rules of Procedure

The following Model Rules of Procedure promulgated by the Attorney General of the State of Oregon in effect on January 01, 2008, are adopted by the Board by reference. These rules apply to rule making and to the conduct of contested cases, respectively.

(1) OAR 137-001-0005 through 137-001-0100;

(2) OAR 137-003-0000 through 137-003-0700.

[ED. NOTE: The full text of the Attorney General’s Model Rules of Procedure is available from the office of the Attorney General or Board of Pharmacy.]

Stat. Auth.: ORS 183.341 & 689.205
Stats. Implemented: ORS 183.341
Hist.: 1PB 25, f. 3-20-72, ef. 4-15-72; 1PB 31, f. 11-20-73, ef. 12-11-73; 1PB 42, f. & ef. 4-6-76; Renumbered from 855-010-0030; 1PB 7-1978(Temp), f. & ef. 7-1-78; 1PB 9-1978, f. & ef. 10-23-78; 1PB 1-1980, f. & ef. 1-21-80; 1PB 3-1981, f. & ef. 12-15-81; PB 2-1987, f. & ef. 3-30-87; PB 5-1988, f. & cert. ef. 10-17-88; PB 4-1992, f. & cert. ef. 8-25-92; PB 1 -1996, f. & cert. ef. 4-5-96; BP 1-2001, f. & cert. ef. 3-5-01; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; BP 5-2004, f. & cert. ef. 10-1-04; BP 13-2006, f. & cert. ef. 12-19-06; BP 3-2008, f. & cert. ef. 7-1-08

855-001-0010

Requiring an Answer to Charges as Part of Notices to Parties in Contested Cases

In addition to the requirements stated in rule 137-003-0505 of the Attorney General's Model Rules of Procedure adopted under OAR 855-001-0005, the notice to parties in contested cases may include a statement that an answer to the assertions or charges will be required, and if so, the consequences of failure to answer may be by enclosing a copy of rule 855-001-0015 with the notice.

Stat. Auth.: ORS 183
Stats. Implemented: ORS 689
Hist.: 1PB 48(Temp), f. & ef. 2-14-77; 1PB 50, f. & ef. 4-20-77; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02

855-001-0012

Time For Requesting a Contested Case Hearing

A request for a contested case hearing must be in writing and must be received by the Board within twenty-one days from the date the contested case notice was served.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151
Hist.:BP 1-2001, f. & cert. ef. 3-5-01

855-001-0015

Hearing Request and Answers: Consequences of Failure to Answer

(1) A hearing request, and answer when required, shall be made in writing to the Board by the party or his attorney and an answer shall include the following:

(a) An admission or denial of each factual matter alleged in the notice;

(b) A short and plain statement of each relevant affirmative defense the party may have.

(2) Except for good cause:

(a) Factual matters alleged in the notice and not denied in the answer shall be presumed admitted;

(b) Failure to raise a particular defense in the answer will be considered a waiver of such defense;

(c) New matters alleged in the answer (affirmative defenses) shall be presumed to be denied by the agency; and

(d) Evidence shall not be taken on any issue not raised in the notice and the answer.

Stat. Auth.: ORS 183
Stats. Implemented:
Hist.: 1PB 48(Temp), f. & ef. 2-14-77; 1PB 50, f. & ef. 4-20-77

855-001-0016

Filing Exceptions and Argument to the Board

After a proposed order has been served on a party, the Board shall notify the party when written exceptions must be filed to be considered by the Board and the Board shall notify the party when the party may appear before the Board to present argument regarding the proposed order.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151
Hist.: BP 1-2001, f. & cert. ef. 3-5-01

855-001-0017

Petition for Reconsideration or Rehearing As Condition for Judicial Review

All parties, including limited parties, must file a petition for reconsideration or rehearing with the Board as a condition for obtaining judicial review of any order of the Board.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151
Hist.: BP 1-2001, f. & cert. ef. 3-5-01

855-001-0035

Duty to Cooperate

Every licensee and registrant of the Board shall cooperate with the Board and shall respond fully and truthfully to inquiries from and comply with any requests from the Board, subject only to the exercise of any applicable right or privilege.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689
Hist.: PB 1-1992, f. & cert. ef. 1-31-92; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02

855-001-0040

Inspections

(1) The Board or its authorized representative may enter and shall be allowed entry to any drug outlet where drugs are stored, and the premises where the records associated with those drugs are stored, to conduct inspections at reasonable times in a reasonable manner for the purpose of:

(a) Inspecting, copying, and verifying the correctness of records, reports, or other documents required to be kept under the Uniform Controlled Substances Act, the Oregon Pharmacy Act and these rules including, but not limited to, shipping records identifying the name of each carrier used and the date and quantity of each shipment, and storage records identifying the name of each warehouse used and the date and quantity of each;

(b) Inspecting within reasonable limits and a reasonable manner all pertinent equipment, finished and unfinished drugs and other substances or materials, containers, and labeling found at the drug outlet;

(c) Making a physical inventory of all drugs on hand at the premises;

(d) Collecting samples of drugs or ingredients;

(e) Checking of records and information on distribution of drugs by the registrants as they relate to total distribution of the registrant;

(f) All other things appropriate for verification of the records, reports, documents referred to above or otherwise bearing on the provisions of the Uniform Controlled Substances Act, the Oregon Pharmacy Act and these rules.

(2) The inspections hereunder may be conducted in connection with applications for initial or renewal registration or modification or amendment thereof and at such other times where the Board or its authorized representative determines that there is reasonable basis for concluding that inspection is necessitated in order to ensure that there is compliance with the Uniform Controlled Substances Act, the Oregon Pharmacy Act and these rules.

(3) Refusal to allow inspection is grounds for denial, suspension, or revocation of a registration.

Stat. Auth.: ORS 475.125 & ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: 1PB 6-1978(Temp), f. & ef. 7-1-78; 1PB 8-1978, f. & ef. 10-17-78; 1PB 6-1982, f. & ef. 8-6-82; Renumbered from 855-080-0060, BP 1-2007, f. & cert. ef. 6-29-07

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