Current through Register Vol. 54, No. 44, November 2, 2024
(a)
General. In accordance
with sections 3 and 4 of the act (35 P. S. §§
780-103 and
780-104), this section lists
all controlled substances. Section 4 of the act (35 P. S. §
780-104) designates specific substances for
inclusion under the five schedules. The substances listed in this section
include those listed by section 4 of the act (35 P. S. §
780-104) and those that have been added by
the Secretary after consultation with the Drug, Device and Cosmetic
Board.
(b)
Schedule
I. In determining that a substance comes within this schedule, the
Secretary will find: a high potential for abuse; no currently accepted medical
use in the United States; and a lack of accepted safety for use under medical
supervision. The following controlled substances are included in this schedule:
(1) The following opiates, including their
isomers, esters, ethers, salts, and salts of isomers, esters, and ethers,
unless specifically excepted whenever the existence of the isomers, esters,
ethers, and salts is possible within the specific chemical designation:
(i) [Reserved].
(ii) Allylprodine.
(iii) Alphacetylmethadol.
(iv) Alphameprodine.
(v) Alphamethadol.
(v.1) Alpha-methylfentanyl.
(vi) Benzethidine.
(vii) Betacetylmethadol.
(viii) Betameprodine.
(ix) Betamethadol.
(x) Betaprodine.
(xi) Clonitazene.
(xii) Dextromoramide.
(xiii) Dextrorphan (except its
methylether).
(xiv)
Diampromide.
(xv)
Diethylthiambutene.
(xvi)
Dimenoxadol.
(xvii)
Dimepheptanol.
(xviii)
Dimethylthiambutene.
(xix)
Dioxaphetyl butyrate.
(xx)
Dipipanone.
(xxi)
Ethylmethylthiambutene.
(xxii)
Etonitazene.
(xxiii)
Etoxeridine.
(xxiv)
Furethidine.
(xxv)
Hydroxypethidine.
(xxvi)
Ketobemidone.
(xxvii)
Levomoramide.
(xxviii)
Levophenacylmorphan.
(xxix)
Morpheridine.
(xxx)
Noracymethadol.
(xxxi)
Norlevorphanol.
(xxxii)
Normethadone.
(xxxiii)
Norpipanone.
(xxxiv)
Phenadoxone.
(xxxv)
Phenampromide.
(xxxvi)
Phenomorphan.
(xxxvii)
Phenoperidine.
(xxxviii)
Piritramide.
(xxxix)
Proheptazine.
(xl)
Properidine.
(xli)
Racemoramide.
(xlii)
Tilidine.
(xliii)
Trimeperidine.
(xliv)
[Reserved].
(xlv)
3-Methylfentanyl.
(xlvi)
1-Methyl-4-Phenyl-4-Propionoxypiperidine (MPPP).
(xlvii)
1-(2-Phenylethyl)-4-Phenyl-4-etyloxypiperidine (PEPAP).
(xlviii) Para-fluorofentanyl.
(xlix) Acetyl-alpha-methylfentanyl.
(l) Alph-methylthiofentanyl.
(li) Beta-hydroxyfentanyl.
(lii) 3 Methylthiofentanyl.
(liii) Thiofentanyl.
(liv)
Beta-hydroxy-3-methylfentanyl.
(2) The following opium derivatives, their
salts, isomers and salts of isomers, unless specifically excepted, whenever the
existence of the salts, isomers, and salts of isomers is possible within the
specific chemical designation:
(i)
Acetorphine.
(ii)
Acetyldihydrocodeine.
(iii)
Benzylmorphine.
(iv) Codeine
methylbromide.
(v)
Codeine-N-Oxide.
(vi)
Cyprenorphine.
(vii)
Desomorphine.
(viii)
Dihydromorphine.
(ix) Drotebanol
(added August 6, 1978).
(x)
Etorphine.
(xi) Heroin.
(xii) Hydromorphinol.
(xiii) Methyldesorphine.
(xiv) Methylhydromorphine.
(xv) Morphine methylbromide.
(xvi) Morphine methylsulfonate.
(xvii) Morphine-N-Oxide.
(xviii) Myrophine.
(xix) Nicocodeine.
(xx) Nicomorphine.
(xxi) Normorphine.
(xxii) Pholcodine.
(xxiii) Thebacon.
(3) A material, compound, mixture or
preparation which contains any quantity of the following hallucinogenic
substances, their salts, isomers, and salts of isomers, unless specifically
excepted, whenever the existence of the salts, isomers, and salts of isomers is
possible within the specific chemical designation:
(i) 3,4-methylenedioxy amphetamine.
(ii) 5-methoxy-3, 4-methylenedioxy
amphetamine.
(iii) 3,4,5-trimethoxy
amphetamine.
(iv)
Bufotenine.
(v)
Diethyltryptamine.
(vi)
Dimethyltryptamine.
(vii)
4-methyl-2, 5-dimethoxyamphetamine.
(viii) Ibogaine.
(ix) Lysergic acid diethylamide.
(x) Mescaline.
(xi) Peyote.
(xii) N-ethyl-3-piperidyl
benzilate.
(xiii)
N-methyl-3-piperidyl benzilate.
(xiv) Psilocybin.
(xv) Psilocyn.
(xvi) Tetrahydrocannabinols.
(xvii) 3,
4-methylenedioxy-N-ethylamphetamine.
(xviii) N-hydroxy-3,
4-methylenedioxyamphetamine.
(xix)
2, 5-Dimethoxy-4-ethylamphetamine (DOET).
(xx) 4 Bromo 2, 5
Dimethoxyphenethylamine.
(4) Marihuana.
(5) 4-Bromo-2, 5 Dimethoxyamphetamine
(4-Bromo, 2, 5 DMA) (added October 17, 1975).
(6) Unless specifically excepted or unless
listed in another schedule, a material, compound, mixture or preparation which
contains any quantity of the following substances including the salts, isomers
and salts of isomers:
(i)
Fenethylline.
(ii)
N-ethylamphetamine.
(iii)
Methaqualone.
(iv)
Bromazepam.
(v)
Camazepam.
(vi)
Clotiazepam.
(vii)
Cloxazolam.
(viii)
Delorazepam.
(ix) Ethyl
loflazepate.
(x)
Fludiazepam.
(xi)
Flunitrazepam.
(xii)
Haloxazolam.
(xiii)
Ketazolam.
(xiv)
Loprazolam.
(xv)
Lormetazepam.
(xvi)
Medazepam.
(xvii) Nimetazepam.
(xiii) Nitrazepam.
(xix) Nordiazepam.
(xx) Oxazolam.
(xxi) Pinazepam.
(xxii) Tetrazepam.
(xxiiii) 3, 4-Methylenedioxymethamphetamine
(MDMA)
(xxiv)
4-methylaminorex.
(xxv)
Cathinone.
(xxvi) Methcathinone
HCL.
(xxvii)
Dimethylamphetamine.
(xxiii)
1-(3-trifluoromethylphenyl) Piperazine (TFMPP)
(xxix) N-Benzylpiperazine (BZP)
(xxx) Alpha-Methyltryptamine (AMT)
(xxxi) 2-5
Dimethoxy-4-(N)-Propylthiophenethylamine (2C-T-7)
(xxxii) 5-Methoxy-N, N-Diisopropyltryptamine
(5-MEO-DIPT)
(c)
Schedule II. In
determining that a substance comes within this schedule, the Secretary will
find: a high potential for abuse; currently accepted medical use in the United
States; or currently accepted medical use with severe restrictions and abuse
may lead to severe psychic or physical dependence. The following controlled
substances are included in this schedule:
(1)
The following substances of any quantity, except those narcotics specifically
excepted or listed in other schedules, whether produced directly or indirectly
by extraction from substances of vegetable origin, or independently by means of
chemical synthesis, or by combination of extraction and chemical synthesis:
(i) Opium and opiate, and a salt, compound,
derivative or preparation of opium or opiate.
(ii) A salt, compound, derivative or
preparation thereof which is chemically equivalent or identical with the
substances referred to in subparagraph (i) except that these substances may not
include the isoquinoline alkaloids of opium.
(iii) Opium poppy and poppy straw.
(iv) Coca leaves and a salt, compound,
derivative or preparation of coca leaves, and a salt, compound, derivative or
preparation thereof which is chemically equivalent or identical with these
substances, but may not include decocanized coca leaves or extracts of coca
leaves, which extracts do not contain cocaine or ecgonine.
(2) The following opiates, including their
isomers, esters, ethers, salts and salts of isomers, esters and ethers, of any
quantity, unless specifically excepted or listed in another schedule, whenever
the existence of the isomers, esters, ethers and salts is possible within the
specific chemical designation:
(i)
Alphaprodine.
(ii)
Anileridine.
(iii)
Bezitramide.
(iv)
Dihydrocodeine.
(v)
Diphenoxylate.
(vi)
Fentanyl.
(vii)
Isomethadone.
(viii)
Levomethorphan.
(ix)
Levorphanol.
(x)
Metazocine.
(xi)
Methadone.
(xii)
Methadone-Intermediate, 4-cyano-2-dimethylamino-4, 4-diphenyl butane.
(xiii) Moramide-Intermediate,
2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylicacid.
(xiv) Pethidine.
(xv) Pethidine-Intermediate-A,
4-cyano-1-methyl-4-phenylpiperidine.
(xvi) Pethidine-Intermediate-B,
ethyl-4-phenylpiperidine-4-carboxylate.
(xvii) Pethidine-Intermediate-C,
1-methyl-4-phenylpiperidine-4-carboxylic acid.
(xviii) Phenazocine.
(xix) Piminodine.
(xx) Propiram (added August 5,
1978).
(xxi)
Racemethorphan.
(xxii)
Racemorphan.
(xxiii)
Sufentanil.
(xxiv)
Alfentanil.
(xxv)
Carfentanil.
(xxvi) Levo-Alpha
Acetyl-Methadol.
(3)
Unless specifically excepted or unless listed in another schedule, a material,
compound, mixture or preparation which contains any quantity of the following
substances:
(i) Amphetamine, its salts,
optical isomers and salts of its optical isomers.
(ii) Phenmetrazine and its salts.
(iii) Methylphenidate.
(iv) Methamphetamine including its salts,
isomers and salts of isomers.
(v)
Phenylacetone.
(vi)
Nabilone.
(vii)
Glutethimide.
(4) The
phrase "opiates" as used in section 4 of the act (35 P. S. §
780-104) and elsewhere throughout the act may
not include the dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its
salts, but does include its racemic and levorotatory forms.
(5) A material, compound, mixture or
preparation, unless specifically excepted, which contains a quantity of:
(i) Phencyclidine.
(ii) 1-phenylcyclohexylamine.
(iii)
1-piperidinocyclohexanecarbonitrile.
(iv) Nabilone.
(6) Unless specifically excepted or unless
listed in another schedule, any material, compound, mixture or preparation
which contains any quantity of the following substances, including its salts,
isomers and salts of isomers whenever the existence of the salts, isomers and
salts of isomers is possible within the specific chemical designation:
(i) Amobarbital (added August 21,
1976).
(ii) Secobarbital (added
August 21, 1976).
(iii)
Pentobarbital (added August 21, 1976).
(d)
Schedule III. In
determining that a substance comes within this schedule, the Secretary will
find: a potential for abuse less than the substances listed in Schedules I and
II; well documented and currently accepted medical use in the United States;
and abuse may lead to moderate or low physical dependence. The following
classes of controlled substances are included in this schedule:
(1) A material, compound, mixture or
preparation unless specifically excepted or unless listed in another schedule
which contains any quantity of the following substances:
(i) A substance which contains any quantity
of a derivative of barbituric acid, or a salt of a derivative of barbituric
acid.
(ii) Chorhexadol.
(iii) Lysergic acid.
(iv) Lysergic acid amide.
(v) Methyprylon.
(vi) Sulfondiethylmethane.
(vii) Sulfonethylmethane.
(viii) Sulfonmethane.
(2) Nalorphine.
(3) A material, compound, mixture, or
preparation containing limited quantities of the following narcotic drugs, or
salts thereof, unless specifically excepted or listed in other schedules.
(i) Not more than 1.8 grams of codeine per
100 milliliters or not more than 90 milligrams per dosage unit, with an equal
or greater quantity of an isoquinoline alkaloid of opium.
(ii) Not more than 1.8 grams of codeine per
100 milliliters or not more than 90 milligrams per dosage unit, with one or
more active, nonnarcotic ingredients in recognized therapeutic
amounts.
(iii) Not more than 300
milligrams of dihydrocodeinone per 100 milliliters or not more than 15
milligrams per dosage unit, with a fourfold or greater quantity of an
isoquinolene alkaloid of opium.
(iv) Not more than 300 milligrams of
dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage
unit, with one or more active, nonnarcotic ingredients in recognized
therapeutic amounts.
(v) Not more
than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90
milligrams per dosage unit, with one or more active, nonnarcotic ingredients in
recognized therapeutic amounts.
(vi) Not more than 300 milligrams of
ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage
unit, with one or more active, nonnarcotic ingredients in recognized
therapeutic amounts.
(vii) Not more
than 500 milligrams of opium per 100 milliliters or per 100 grams, or not more
than 2.5 milligrams per dosage unit with one or more active, nonnarcotic
ingredients in recognized therapeutic amounts.
(4) Unless specifically excepted or unless
listed in another schedule, a material, compound, mixture, or preparation which
contains any quantity of the following substances including its salts, isomers,
whether optical position or geometric, and salts of the isomers whenever the
existence of the salts, isomers, and salts of isomers is possible within the
specific chemical designation, Schedule III shall include the following:
(i) Benzphetamine (added August 21,
1976).
(ii) Chlorphentermine (added
August 21, 1976).
(iii) Clortermine
(added August 21, 1976).
(iv)
[Reserved].
(v) Phendimetrazine
(added August 21, 1976).
(5) A compound, mixture or preparation or a
salt thereof including one or more other active medicinal ingredients which are
not listed in a schedule containing the following:
(i) Amobarbital.
(ii) Secobarbital.
(iii) Pentobarbital.
(6) A suppository dosage form or a salt
thereof approved by the Food and Drug Administration for marketing only as a
suppository containing the following:
(i)
Amobarbital.
(ii)
Secobarbital.
(iii)
Pentobarbital.
(7) The
Secretary may, by regulation, except a compound, mixture, or preparation
containing a drug or controlled substance listed in this schedule from the
application of those provisions of the act covering controlled substances, if
the compound, mixture, or preparation contains one or more active medicinal
ingredients not having a stimulant or depressant effect on the central nervous
system; provided, that the admixtures shall be included therein in the
combinations, quantity, proportion, or concentration as to vitiate the
potential for abuse of the substances which do have a stimulant or depressant
effect on the central nervous system.
(8) The Secretary will, by regulation, exempt
a nonnarcotic substance from the control under the act if the substance may,
under the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. §
301 et seq.), be lawfully sold over the
counter without a prescription.
(9)
A material, compound, mixture or preparation, unless specifically excepted,
which contains a quantity of Dronabinol-synthetic-in sesame oil encapsulated in
a soft gelatin capsule but only those drug products approved by the United
States Food and Drug Administration.
(10) Buprenorphine.
(e)
Schedule IV. In
determining that a substance comes within this schedule, the Secretary will
find: a low potential for abuse relative to substances in Schedule III;
currently accepted medical use in the United States; and limited physical or
psychological dependence liability relative to the substances listed in
Schedule III. The following controlled substances are included in this
schedule:
(1) A material, compound, mixture or
preparation, unless specifically excepted or unless listed in another schedule,
which contains a quantity of the following substances:
(i) Barbital.
(ii) Chloral betaine.
(iii) Chloral hydrate.
(iv) Ethchlorvynol.
(v) Ethinamate.
(vi) Methohexital.
(vii) Meprobamate.
(viii) Methylphenobarbital.
(ix) Paraldehyde.
(x) Petrichloral.
(xi) Phenobarbital.
(xii) Chlordiazepoxide (added August 21,
1976).
(xiii) Diazepam (added
August 21, 1976).
(xiv) Oxazepam
(added August 21, 1976).
(xv)
Clorazepate (added August 21, 1976).
(xvi) Flurazepam (added August 21,
1976).
(xvii) Clonazepam (added
August 21, 1976).
(xviii)
Mebutamate (added August 21, 1976).
(xix) Temazepam.
(xx) Alprazolam.
(xxi) Halazepam.
(xxii) Triazolam.
(xxiii) Midazolam.
(xxiv) Quazepam.
(xxv) Estazolam.
(xxvi) Zolpidem.
(xxvii) Clobazam. (added March 27,
2012)
(2) A material,
compound, mixture, or preparation which contains any quantity of the following
substance including its salts, isomers whether optical position or geometric,
and salts of the isomers, whenever the existence of the salts, isomers, and
salts of isomers is possible:
(i) Fenfluramine
(added August 21, 1976).
(ii)
Pentazocine (added January 19, 1980).
(iii) Lorazepam (added January 19,
1980).
(iv) Prazepam (added January
19, 1980).
(v) Dextropropoxyphene
(added January 19, 1980).
(3) Unless specifically excepted or unless
listed in another schedule, a material, compound, mixture or preparation which
contains any quantity of the following substances including its salts, isomers
whether optical position or geometric, and salts of the isomers whenever the
existence of the salts, isomers and salts of isomers is possible within the
specific chemical designation:
(i)
Diethylpropion (added August 21, 1976).
(ii) Phentermine (added August 21,
1976).
(iii) Pemoline (added August
21, 1976).
(iv) Mazindol.
(v) Pipradol.
(vi) SPA
(1-dimethylamino-1-2-diphenylethane).
(vii) Cathine.
(viii) Fencamfamin.
(ix) Fenproporex.
(x) Mefenorex.
(xi) Butorphanol.
(xii) Sibutramine.
(4) The Secretary may, by regulation, except
a compound, mixture, or preparation containing a drug or controlled dangerous
substance listed in paragraph (1) from the application of those provisions of
the act, sections 3 and 4 of the act (35 P. S. §§
780-103 and
780-104), covering controlled
drugs, if the compound, mixture, or preparation contains one or more active
medicinal ingredients not having a stimulant or depressant effect on the
central nervous system; provided that the admixtures shall be included therein
in combinations, quantity, proportion, or concentration as to vitiate the
potential for abuse of the substances which do have a stimulant or depressant
effect on the central nervous system.
(5) The Secretary shall by regulation exempt
a nonnarcotic substance from the control under the act if the substance may,
under the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. §
301
et seq.) be lawfully
sold over the counter without a prescription.
(6) A compound, mixture, or preparation which
purports to have a cough suppressant effect and which contains a limited
quantity of the following narcotics or their salts, and which contains in
addition one or more nonnarcotic active medicinal ingredients in sufficient
proportion to confer upon the compound, mixture, or preparation, valuable
medicinal qualities other than those possessed by the narcotic alone shall be
included under this schedule:
(i) Not more
than 200 milligrams of codeine, or any of its salts, per 100 milliliters or per
100 grams and not more than 10 milligrams per dosage unit.
(ii) Not more than 100 milligrams of
dihydrocodeine, or any of its salts, per 100 milliliters or per 100 grams and
not more than 5 milligrams per dosage unit.
(iii) Not more than 100 milligrams of
ethylmorphine, or any of its salts, per 100 milliliters or per 100 grams and
not more than 5 milligrams per dosage unit.
(f)
Schedule V. In
determining that a substance comes within this schedule, the Secretary will
find: a low potential for abuse relative to the substances listed in Schedule
IV; currently accepted medical use in the United States; and limited physical
dependence or psychological dependence liability relative to the substances
listed in Schedule IV. The following controlled substances are included in this
schedule:
(1) A compound, mixture, or
preparation containing limited quantities of any of the following narcotics or
any of their salts, which shall include one or more nonnarcotic active
medicinal ingredients in sufficient proportion to confer upon the compound,
mixture, or preparation, valuable medicinal qualities other than those
possessed by the narcotic alone:
(i) Not more
than 200 milligrams of codeine, or any of its salts, per 100 milliliters or per
100 grams and not more than 10 milligrams per dosage unit.
(ii) Not more than 100 milligrams of
dihydrocodeine or any of its salts, per 100 milliliters or per 100 grams and
not more than 5 milligrams per dosage unit.
(iii) Not more than 100 milligrams of
ethylmorphine, or any of its salts, per 100 milliliters or per 100 grams and
not more than 5 milligrams per dosage unit.
(iv) Not more than 2.5 milligrams of
diphenoxylate and not less than 25 micrograms of altropine sulfate per dosage
unit.
(v) Not more than 100
milligrams of opium per 100 milliliters or per 100 grams, or not more than 5
milligrams per dosage unit.
(2) Propylhexadrine, except when labeled for
over-the-counter drug sale in conformity with
21 CFR
1308.15 (relating to schedule V).
(3) Pyrovalerone.
The provisions of this §25.72 amended under section
2102(g) of The Administrative Code of 1929 (71 P. S. §
532(g)); sections 3(a) and
(c) and 4 of The Controlled Substance, Drug, Device and Cosmetic Act
(35
P. S. §§
780-103(a) and
(c) and
780-104); and section 2 of
the Optometric Practice and Licensure Act (63 P. S. §
244.2).
This section cited in 28 Pa. Code §
551.3 (relating to definitions);
and 49 Pa. Code §21.284a (relating to prescribing
and dispensing drugs).