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Schedule Of Controlled Substances


Published: 2015

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The Oregon Administrative Rules contain OARs filed through November 15, 2015

 

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BOARD OF PHARMACY

 

DIVISION 80
SCHEDULE OF CONTROLLED SUBSTANCES

855-080-0015
Definitions
As used in these rules:
(1) "Act" means the Uniform Controlled Substances Act, ORS Chapter 475, and rules thereunder;
(2) "CFR" means Code of Federal Regulations;
(3) The term "registration" or variants thereof means the annual registration required of manufacturers, distributors and dispensers of controlled substances under ORS 475.125, and the term "registrants" or variants thereof refers to persons so registered; provided that where references of this nature are used in CFR sections referred to in these rules, the reference is to the registration requirements and registrants under the Federal Controlled Substances Act, and Title 21, CFR.
(4) "USC" means United States Code;
(5) Terms not defined in this rule have the definitions set forth in ORS 475.005.
Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 475.035 & 475.940

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; PB 5-1991, f. & cert. ef. 9-19-91; BP 3-2002(Temp), f. & cert. ef. 3-1-02 thru 8-23-02; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; BP 1-2007, f. & cert. ef. 6-29-07
855-080-0020
Schedules
Pursuant to ORS 475.005(6) those drugs and their immediate precursors classified in Schedules I through V under the Federal Controlled Substances Act, 21 U.S.C. Sections 811 to 812 and as amended by the Board pursuant to ORS 475.035 are the controlled substances for purposes of regulation and control under the Act. Those schedules are set out in OAR 855-080-0021 through 855-080-0026.
Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 475.035

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; 1PB 2-1984, f. & ef. 3-7-84; 1PB 4-1984(Temp), f. & ef. 9-17-84; 1PB 1-1985, f. & ef. 2-27-85; 1PB 2-1985, f. & ef. 7-24-85; 1PB 4-1985, f. & ef. 12-2-85; 1PB 2-1986, f. & ef. 7-10-86; PB 4-1987, f. & ef. 3-30-87; PB 5-1991, f. & cert. ef. 9-19-91; BP 8-2010, f. & cert. ef. 6-29-10
855-080-0021
Schedule I
(1) Schedule I consists of the drugs and
other substances, by whatever official, common, usual, chemical, or brand name designated,
listed in 21CFR part 1308.11, and unless specifically excepted or unless listed
in another schedule, any quantity of the following substances, including their isomers,
esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence
of such isomers, esters, ethers, and salts is possible within the specific chemical
designation:
(a) 1,4-butanediol;
(b) gamma-butyrolactone
(c) Methamphetamine, except
as listed in OAR 855-080-0022;
(d) Substituted derivatives
of cathinone and methcathinone that are not listed in OARs 855-080-0022 through
0026 (Schedules II through V) or are not FDA approved drugs, including but not limited
to,
(A) Methylmethcathinone (Mephedrone);
(B) Methylenedioxypyrovalerone
(MDPV);
(C) Methylenedioxymethylcathinone
(Methylone);
(D) 2-Methylamino-3’,4’-(methylenedioxy)-butyrophenone
(Butylone);
(E) Fluoromethcathinone (Flephedrone);
(F) 4-Methoxymethcathinone (Methedrone).
(2) Schedule I also includes
any compounds in the following structural classes (2a–2k) and their salts,
that are not FDA approved drugs, unless specifically excepted or when in the possession
of an FDA registered manufacturer or a registered research facility, or a person
for the purpose of sale to an FDA registered manufacturer or a registered research
facility:
(a) Naphthoylindoles: Any compound
containing a 3-(1-naphthoyl)indole structure with substitution at the nitrogen atom
of the indole ring whether or not further substituted in the indole ring to any
extent and whether or not substituted in the naphthyl ring to any extent. Examples
of this structural class include but are not limited to: JWH-015, JWH-018, JWH-019,
JWH-073, JWH-081, JWH-122, JWH-200, JWH-210, AM-1220, MAM-2201 and AM-2201;
(b) Phenylacetylindoles: Any
compound containing a 3-phenylacetylindole structure with substitution at the nitrogen
atom of the indole ring whether or not further substituted in the indole ring to
any extent, whether or not substituted in the phenyl ring to any extent. Examples
of this structural class include but are not limited to: JWH-167, JWH -201, JWH-203,
JWH-250, JWH-251, JWH-302 and RCS-8;
(c) Benzoylindoles: Any compound
containing a 3-(benzoyl)indole structure with substitution at the nitrogen atom
of the indole ring whether or not further substituted in the indole ring to any
extent and whether or not substituted in the phenyl ring to any extent. Examples
of this structural class include but are not limited to: RCS-4, AM-694, AM-1241,
and AM-2233;
(d) Cyclohexylphenols: Any compound
containing a 2-(3-hydroxycyclohexyl)phenol structure with substitution at the 5-position
of the phenolic ring whether or not substituted in the cyclohexyl ring to any extent.
Examples of this structural class include but are not limited to: CP 47,497 and
its C8 homologue (cannabicyclohexanol);
(e) Naphthylmethylindoles: Any
compound containing a 1H-indol-3-yl-(1-naphthyl)methane structure with substitution
at the nitrogen atom of the indole ring whether or not further substituted in the
indole ring to any extent and whether or not substituted in the naphthyl ring to
any extent;
(f) Naphthoylpyrroles: Any compound
containing a 3-(1-naphthoyl)pyrrole structure with substitution at the nitrogen
atom of the pyrrole ring whether or not further substituted in the pyrrole ring
to any extent and whether or not substituted in the naphthyl ring to any extent;
(g) Naphthylmethylindenes: Any
compound containing a 1-(1-naphthylmethyl)indene structure with substitution at
the 3-position of the indene ring whether or not further substituted in the indene
ring to any extent and whether or not substituted in the naphthyl ring to any extent;
(h) Cyclopropanoylindoles: Any
compound containing an 3-(cyclopropylmethanoyl)indole structure with substitution
at the nitrogen atom of the indole ring, whether or not further substituted in the
indole ring to any extent and whether or not substituted in the cyclopropyl ring
to any extent. Examples of this structural class include but are not limited to:
UR-144, XLR-11 and A-796,260;
(i) Adamantoylindoles: Any compound
containing a 3-(1-adamantoyl)indole structure with substitution at the nitrogen
atom of the indole ring, whether or not further substituted in the indole ring to
any extent and whether or not substituted in the adamantyl ring to any extent. Examples
of this structural class include but are not limited to: AM-1248 and
AB-001;
(j) Adamantylindolecarboxamides:
Any compound containing an N-adamantyl-1-indole-3-carboxamide with substitution
at the nitrogen atom of the indole ring, whether or not further substituted in the
indole ring to any extent and whether or not substituted in the adamantyl ring to
any extent. Examples of this structural class include but are not limited to: STS-135
and 2NE1; and
(k) Adamantylindazolecarboxamides:
Any compound containing an N-adamantyl-1-indazole-3-carboxamide with substitution
at the nitrogen atom of the indazole ring, whether or not further
substituted in the indazole
ring to any extent and whether or not substituted in the adamantyl ring to any extent.
Examples of this structural class include but are not limited to: AKB48.
(3) Schedule I also includes
any other cannabinoid receptor agonist that is not listed in OARs 855-080-0022 through
0026 (Schedules II through V) or is not an FDA approved drug.
(4) Exceptions. The following
are exceptions to subsection (1) of this rule:
(a) 1, 4-butanediol and gamma-butyrolactone
when in the possession of a person for the purpose of its sale to a legitimate manufacturer
of industrial products and the person is in compliance with the Drug Enforcement
Administration requirements for List I Chemicals;
(b) 1,4-butanediol and gamma-butyrolactone
when in the possession of a person for the purpose of the legitimate manufacture
of industrial products;
(c) Marijuana and delta-9-tetrahydrocannabinol
(THC).
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 475.035, 475.059
& 475.065
Hist.: PB 4-1987, f. &
ef. 3-30-87; PB 8-1987, f. & ef. 9-30-87; PB 10-1987, f. & ef. 12-8-87;
PB 15-1989, f. & cert. ef. 12-26-89; PB 9-1990, f. & cert. ef. 12-5-90;
PB 5-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and
corrected 2-7-92); PB 1-1994, f. & cert. ef. 2-2-94; PB 1-1996, f. & cert.
ef. 4-5-96; PB 1-1997, f. & cert. ef. 9-22-97; BP 4-2000, f. & cert. ef.
2-16-00; BP 9-2000, f. & cert. ef. 6-29-00; BP 2-2002(Temp), f. & cert.
ef. 2-4-02 thru 7-31-02; BP 3-2002(Temp), f. & cert. ef. 3-1-02 thru 8-23-02;
BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; BP 5-2002, f. & cert. ef. 11-14-02;
BP 1-2003, f. & cert. ef. 1-14-03; BP 1-2007, f. & cert. ef. 6-29-07; BP
8-2010, f. & cert. ef. 6-29-10; BP 10-2010(Temp), f. & cert. ef. 10-15-10
thru 4-11-11; BP 2-2011, f. & cert. ef. 4-11-11; BP 9-2013, f. & cert. ef.
10-28-13; BP 11-2013(Temp), f. & cert. ef. 12-20-13 thru 6-18-14; BP 4-2014(Temp),
f. 2-27-14, cert. ef. 2-28-14 thru 8-27-14; BP 5-2014(Temp), f. & cert. ef.
4-15-14 thru 8-27-14; BP 7-2014, f. & cert. ef. 6-18-14
855-080-0022
Schedule II
Schedule II consists of the drugs and other
substances by whatever official, common, usual, chemical, or brand name designated,
listed in 21 CFR part 1308.12 and any quantity of the following substances:
(1) Marijuana and delta-9-tetrahydrocannabinol
(THC).
(2) Methamphetamine, when in
the form of an FDA approved product containing methamphetamine, its salts, isomers
and salts of its isomers as an active ingredient for the purposes of currently accepted
medical use.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 475.035, 475.059
& 475.065
Hist.: PB 4-1987, f. &
ef. 3-30-87; PB 8-1987, f. & ef. 9-30-87; PB 10-1987, f. & ef. 12-8-87;
PB 15-1989, f. & cert. ef. 12-26-89; PB 9-1990, f. & cert. ef. 12-5-90;
PB 5-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and
corrected 2-7-92); PB 1-1994, f. & cert. ef. 2-2-94; PB 1-1996, f. & cert.
ef. 4-5-96; PB 1-1997, f. & cert. ef. 9-22-97; BP 3-1999(Temp), f. & cert.
ef. 8-9-99 thru 1-17-00; BP 4-2000, f. & cert. ef. 2-16-00; BP 4-2006, f. 6-9-06,
cert. ef. 7-1-06; BP 1-2007, f. & cert. ef. 6-29-07; BP 8-2010, f. & cert.
ef. 6-29-10; BP 10-2014, f. 12-30-14, cert. ef. 1-1-15
855-080-0023
Schedule III
Schedule III consists of the drugs and other substances by whatever official, common, usual, chemical, or brand name designated, listed in 21 CFR part 1308.13; and
(1) Products containing pseudoephedrine or the salts of pseudoephedrine as an active ingredient.
(2) Products containing ephedrine or the salts of ephedrine as an active ingredient.
(3) Products containing phenylpropanolamine or the salts of phenylpropanolamine as an active ingredient.
Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 475.035

Hist.: PB 4-1987, f. & ef. 3-30-87; PB 11-1989, f. & cert. ef. 7-20-89; PB 5-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); BP 3-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00; BP 4-2000, f. & cert. ef. 2-16-00; BP 9-2000, f. & cert. ef. 6-29-00; BP 4-2006, f. 6-9-06, cert. ef. 7-1-06; BP 1-2007, f. & cert. ef. 6-29-07
855-080-0024
Schedule IV
Schedule IV consists of:
(1) The drugs and other substances, by whatever official, common, usual, chemical, or brand name designated, listed in 21 CFR part 1308.14, unless specifically excepted or listed in another schedule: and
(2) Products containing carisoprodol or the salts of carisoprodol as an active ingredient.
Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 475.035

Hist.: PB 4-1987, f. & ef. 3-30-87; PB 5-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); PB 1-1995, f. & cert. ef. 4-27-95; PB 1-1996, f. & cert. ef. 4-5-96; PB 1-1997, f. & cert. ef. 9-22-97; BP 4-2000, f. & cert. ef. 2-16-00; BP 9-2000, f. & cert. ef. 6-29-00; BP 1-2007, f. & cert. ef. 6-29-07
855-080-0026
Schedule V
Schedule V consists of the drugs and other substances, by whatever official, common, usual, chemical, or brand name designated, listed in 21 CFR part 1308.15.
Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 475.035

Hist.: PB 4-1987, f. & ef. 3-30-87; PB 5-1991, f. & cert. ef. 9-19-91; BP 1-2007, f. & cert. ef. 6-29-07
855-080-0028
Excluded Substances
The following drugs and their generic equivalents are excepted from the schedules in OAR 855-080-0021 through 855-080-0026:
(1) Benzedrex inhaler (Propylhexedrine).
(2) Vicks -- Vapor inhaler (Levmetamfetamine).
Stat. Auth.: 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; PB 4-1987, f. & ef. 3-30-87; Renumbered from 855-080-0025; PB 5-1991, f. & cert. ef. 9-19-91; PB 1-1995, f. & cert. ef. 4-27-95; BP 4-2006, f. 6-9-06, cert. ef. 7-1-06; BP 6-2006(Temp), f. & cert. ef. 8-25-06 thru 1-31-07; BP 8-2006, f. & cert. ef. 12-19-06; BP 8-2010, f. & cert. ef. 6-29-10

Registration of Manufacturers, Distributors and Dispensers

855-080-0031
Registration Requirements
Manufacturers, distributors, and pharmacies or other drug outlets are required to register with the Board under the Uniform Controlled Substances Act.
Stat. Auth.: ORS 689.155, 689.205

Stats. Implemented: ORS 475.125

Hist.: 1PB 6-1982, f. & ef. 8-6-82; BP 4-2006, f. 6-9-06, cert. ef. 7-1-06; BP 1-2007, f. & cert. ef. 6-29-07
855-080-0050
Separate Registration for Places of Business
A separate registration is required for each principal place of business where controlled substances are manufactured or from which controlled substances are distributed or dispensed.
Stat. Auth.: ORS 475 & 689

Stats. Implemented:

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
855-080-0055
Separate Registration for Independent Activities
The manufacturing and distributing of controlled substances are deemed activities independent of each other. A separate registration is required for each activity; however, a person registered to manufacture may distribute or dispense any controlled substance which they are registered to manufacture, provided that, unless specifically exempted, they comply with all requirements and duties prescribed by statute and rules for persons registered to distribute or dispense as applicable.
Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 475.125, 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; BP 8-2010, f. & cert. ef. 6-29-10
855-080-0065
Security
(1) Applicants for registration and registrants must comply with the security requirements of 21 CFR 1301.02, 1301.71 through 1301.76 and 1301.90 through1301.93, which apply to their registration classification. The requirements of 21 CFR 1301.75 and 1301.76 relating to "practitioners" are applicable to applicants and registrants who are drug dispensers.
(2) The security requirements of subsection one of this rule apply to all "controlled substances," as defined in these rules, except ephedrine, pseudoephedrine and phenylpropanolamine.
(3) Applicants and registrants must guard against theft and diversion of ephedrine, pseudoephedrine and phenylpropanolamine.
Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 475.135

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; PB 5-1991, f. & cert. ef. 9-19-91; BP 4-2006, f. 6-9-06, cert. ef. 7-1-06; BP 1-2007, f. & cert. ef. 6-29-07
855-080-0070
Records and Inventory
All registered persons shall, as applicable to the registration classification, keep records and maintain inventories in conformance with 21 U.S.C. Section 827; 21CFR 1304.02 through 1304.11; 1304.21 through 1304.26; 1304.31 through 1304.33; except that a written inventory of all controlled substances shall be taken by registrants annually within 365 days of the last written inventory. All such records shall be maintained for a period of three years.
Stat. Auth.: ORS 475.035, 689.205

Stats. Implemented: ORS 475.165

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; 1PB 1-1986, f. & ef. 6-5-86; PB 10-1987, f. & ef. 12-8-87; PB 5-1991, f. & cert. ef. 9-19-91; PB 1-1994, f. & cert. ef. 2-2-94; BP 4-2006, f. 6-9-06, cert. ef. 7-1-06; BP 1-2007, f. & cert. ef. 6-29-07
855-080-0075
Order Forms
Controlled substances in Schedules I and II shall be distributed by a registrant to another registrant only pursuant to an order form in conformance with 21 U.S.C. Section 828 and 21 CFR 1305.01 through 1305.29.
Stat. Auth.: ORS 475 & 689

Stats. Implemented:

Hist.: 1PB 6-1978(Temp), f. & ef. 7-1-78; 1PB 8-1978, f. & ef. 10-17-78; PB 5-1991, f. & cert. ef. 9-19-91; BP 4-2006, f. 6-9-06, cert. ef. 7-1-06
855-080-0080
Special Exceptions
The provisions of 21 CFR 1307.11 through 1307.13 are applicable under the Act.
Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 475.035

Hist.: 1PB 6-1978(Temp), f. & ef. 7-1-78; 1PB 8-1978, f. & ef. 10-17-78; PB 5-1991, f. & cert. ef. 9-19-91; BP 1-2007, f. & cert. ef. 6-29-07

Controlled Substances Prescriptions

855-080-0085
Prescription Requirements
(1) Except as provided in sections (2) and (3) of this rule, the provisions of 21 CFR 1306.01 through 1306.27 and 1304.03(d) shall be complied with by the registrants, practitioners and pharmacists as specified therein in the issuance, preparation, labeling dispensing, recordkeeping and filing of prescriptions for controlled substances. An electronic prescription is permitted for any substance listed in OAR 855-080-0022 through 855-080-0026 when so permitted by federal regulations.
(2) The provisions of 21 CFR 1306.11(a) under section (1) of this rule are amended by deleting "which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act."
(3) The provisions of 21 CFR 1306.21 through 1306.27 under section (1) of this rule shall be deemed to apply also to controlled substances listed in Schedule V.
(4) Controlled substances in Schedules III, IV, and V which are prescription drugs determined by the Board pursuant to ORS 475.185(3) are those prescription drugs as determined under the Federal Food, Drug, and Cosmetic Act. Such drugs are "Legend Drugs" and bear the legend "Caution: Federal law prohibits dispensing without a prescription", or an equivalent legend. In addition, any preparation containing any amount of codeine or its salts, opium, or paregoric in Schedules III, IV, or V is a prescription drug as determined by the Board pursuant to ORS 475.185(3).
(5) "Emergency Situations" as referred to in ORS 475.185(2) mean the same as specified in 21 CFR 290.10.
Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 475.185, 475.188

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; PB 15-1989, f. & cert. ef. 12-26-89; PB 5-1991, f. & cert. ef. 9-19-91; BP 1-2007, f. & cert. ef. 6-29-07; BP 8-2010, f. & cert. ef. 6-29-10
855-080-0095
Verification of Research Registration
Persons conducting research with controlled substances in Sections I through V within this state who are not otherwise exempt from registration pursuant to ORS 475.125(3), may, upon furnishing the Board a copy of a current federal registration certificate issued for such a purpose, pursuant to ORS 475.135, receive written verification of such submission from the Board's Executive Director.
Stat. Auth.: ORS 475

Stats. Implemented:

Hist.: 1PB 6-1978(Temp), f. & ef. 7-1-78; 1PB 8-1978, f. & ef. 10-17-78; BP 4-2006, f. 6-9-06, cert. ef. 7-1-06
855-080-0100
Animal Euthanasia
(1) The following requirements
shall be met in order for a humane society or animal control agency to be registered
or registration renewed to allow the purchase, possession and administration of
sodium pentobarbital for euthanizing injured, sick, homeless or unwanted domestic
pets and other animals:
(a) Storage. All supplies of
sodium pentobarbital shall be kept in a locked cabinet. An assigned person designated
in writing shall be responsible for the security of the sodium pentobarbital. Such
designated person shall allow withdrawal of the drug only to a person certified
by the Oregon State Veterinary Medical Examining Board to administer sodium pentobarbital;
(b) Records. The following records
shall be made at the time of the occurrence and shall be maintained for a minimum
of three years, available for inspection by the Board of Pharmacy and its agents:
(A) A record of the withdrawal
of sodium pentobarbital, signed by the person who takes possession of the sodium
pentobarbital for administration;
(B) A record of the weight,
species of animal and dosage administered for euthanasia signed by the person who
administers the drug and by the designated person responsible for security;
(C) A record of all wastage
signed by the person administering the drug and the designated person responsible
for security; and
(D) A weekly record of verification
of the stock on hand, minus the amounts withdrawn for administration, signed by
the designated person responsible for security;
(E) A record of disposal of
any expired or unwanted sodium pentobarbital. Disposal shall be in a conformance
with 21 CFR 1307.21.
(c) Audits. The registrant shall
submit to random audits of records and analysis of prepared solutions by the State
Board of Pharmacy or its agents.
(2) The fee for registration
shall be paid as specified in division 110 of this chapter of rules.
(3) The Board will suspend or
revoke the registration of any humane society or animal control agency which allows
a person to administer sodium pentobarbital who is not certified by the Oregon State
Veterinary Medical Examining Board to administer such drug.
Stat. Auth.: ORS 475.095, 475.190,
689.205

Stats. Implemented: ORS 689.151
& 689.155

Hist.: 1PB 2-1984, f. &
ef. 3-7-84; PB 9-1990, f. & cert. ef. 12-5-90; PB 5-1991, f. & cert. ef.
9-19-91; BP 6-2011(Temp), f. 10-20-11, cert. ef. 10-31-11 thru 4-27-12; BP 7-2011(Temp),
f. & cert. ef. 12-15-11 thru 4-27-12; Administrative correction, 5-25-12; BP
3-2012, f. & cert. ef. 6-19-12
855-080-0105
Disposal of Drugs
(1) Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier.
(2) Controlled substances which are expired, deteriorated or unwanted shall be disposed of in conformance with 21 CFR 1307.21.
(3) Expired, deteriorated, discontinued, or unwanted controlled substances in a long-term care facility shall be destroyed and the destruction jointly witnessed on the premises by any two of the following:
(a) The consultant pharmacist or registered nurse designee.
(b) The Director of Nursing Services or supervising nurse designee
(c) The administrator of the facility or an administrative designee
(d) A Registered Nurse employed by the facility
(4) The destruction shall be documented and signed by the witnesses and the document retained at the facility for a period of at least three years. Copies of the document shall be sent to the consultant pharmacist. Any destruction of controlled substances deviating from this procedure must be approved by the Board prior to implementation.
(5) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public heath or safety or the health and safety of a patient. A waiver granted under this section shall only be effective when it is issued by the Board in writing.
Stat. Auth.: ORS 475.035 & 689.205

Stats. Implemented: ORS 689.305

Hist.: 1PB 2-1984, f. & ef. 3-7-84; PB 1-1989, f. & cert. ef. 1-3-89; PB 1-1990, f. & cert. ef. 1-23-90; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); PB 1-1996, f. & cert. ef. 4-5-96; BP 4-2006, f. 6-9-06, cert. ef. 7-1-06; BP 8-2010, f. & cert. ef. 6-29-10

The official copy of an Oregon Administrative Rule is
contained in the Administrative Order filed at the Archives Division,
800 Summer St. NE, Salem, Oregon 97310. Any discrepancies with the
published version are satisfied in favor of the Administrative Order.
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