35 Pa. Stat. § 780-104

Current through Pa Acts 2024-53, 2024-56 through 2024-111
Section 780-104 - Schedules of controlled substances

The following schedules include the controlled substances listed or to be listed by whatever official name, common or usual name, chemical name, or trade name designated.

(1) Schedule I--In determining that a substance comes within this schedule, the secretary shall 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:
(i) Any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, unless specifically excepted, whenever the existence of such isomers, esters, ethers and salts is possible within the specific chemical designation:
1. Acetylmethadol.
2. Allylprodine.
3. Alphacetylmethadol.
4. Alphameprodine.
5. Alphamethadol.
6. Benzethidine.
7. Betacetylmethadol.
8. Betameprodine.
9. Betamethadol.
10. Betaprodine.
11. Clonitazene.
12. Dextromoramide.
13. Dextrorphan (except its methylether).
14. Diampromide.
15. Diethylthiambutene.
16. Dimenoxadol.
17. Dimepheptanol.
18. Dimethylthiambutene.
19. Dioxaphetyl butyrate.
20. Dipipanone.
21. Ethylmethylthiambutene.
22. Etonitazene.
23. Etoxeridine.
24. Furethidine.
25. Hydroxypethidine.
26. Ketobemidone.
27. Levomoramide.
28. Levophenacylmorphan.
29. Morpheridine.
30. Noracymethadol.
31. Norlevorphanol.
32. Normethadone.
33. Norpipanone.
34. Phenadoxone.
35. Phenampromide.
36. Phenomorphan.
37. Phenoperidine.
38. Piritramide.
39. Proheptazine.
40. Properidine.
41. Racemoramide.
42. Trimeperidine.
(ii) Any of the following opium derivatives, their salts, isomers and salts of isomers, unless specifically excepted, whenever the existence of such salts, isomers and salts of isomers is possible within the specific chemical designation:
1. Acetorphine.
2. Acetyldihydrocodeine.
3. Benzylmorphine.
4. Codeine methylbromide.
5. Codeine-N-Oxide.
6. Cyprenorphine.
7. Desomorphine.
8. Dihydromorphine.
9. Etorphine.
10. Heroin.
11. Hydromorphinol.
12. Methyldesorphine.
13. Methylhydromorphine.
14. Morphine methylbromide.
15. Morphine methylsulfonate.
16. Morphine-N-Oxide.
17. Myrophine.
18. Nicocodeine.
19. Nicomorphine.
20. Normorphine.
21. Pholcodine.
22. Thebacon.
23. Fentanyl derivatives - any compound not listed under a different schedule, not a Federal Food and Drug Administration-approved drug or not used within legitimate and approved medical research, structurally derived from N-(1-(2- phenethyl)-4-piperidinyl-N-phenyl-propanamide. This shall include the following, their salts, isomers and salts of isomers:
(A) Acetyl fentanyl.
(B) Butyryl fentanyl.
(C) para-Fluorofentanyl.
(D) para-Fluorobutyryl fentanyl.
(E) Furanyl fentanyl.
(F) Hydroxythiofentanyl.
(G) Isobutyrylfentanyl.
(H) 4-methoxy-Butyryl fentanyl.
(I) 3-methyl Fentanyl.
(J) Ocfentanyl.
(K) Valeryl fentanyl.
(iii) Any 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 such salts, isomers, and salts of isomers is possible within the specific chemical designation:
1. 3,4-methylenedioxy amphetamine.
2. 5-methoxy-3,4-methylenedioxy amphetamine.
3. 3,4,5-trimethoxy amphetamine.
4. Bufotenine.
5. Diethyltryptamine.
6. Dimethyltryptamine.
7. 4-methyl-2,5-dimethoxyamphetamine.
8. Ibogaine.
9. Lysergic acid diethylamide.
10. Mescaline.
11. Peyote.
12. N-ethyl-3-piperidyl benzilate.
13. N-methyl-3-piperidyl benzilate.
14. Psilocybin.
15. Psilocyn.
16. Tetrahydrocannabinols.
17. Salvia Divinorum.
18. Salvinorin A.
19. Divinorin A.
20. 3,4-Methylenedioxymethcathinone (Methylone).
21. 3,4- Methylenedioxypyrovalerone (MDPV).
22. 4-Methylmethcathinone (Mephedrone).
23. 4-Methoxymethcathinone.
24. 4-Fluoromethcathinone.
25. 3-Fluoromethcathinone.
26. 3,4-Methylenedioxymethamphetamine.
27. Methoxetamine.
(iii.1) Substituted cathinones - any compound, except bupropion or compounds listed under a different schedule, or compounds used within legitimate and approved medical research, structurally derived from 2-aminopropan-1-one by substitution at the 1-position with monocyclic or fused polycyclic ring systems, whether or not the compound is further modified in any of the following ways:
1. By substitution in the ring system to any extent with alkyl, alkylenedioxy, alkoxy, haloalkyl, hydroxyl or halide substituents whether or not further substituted in the ring system by one or more other univalent substituents.
2. By substitution at the 3-position with an acyclic alkyl substituent.
3. By substitution at the 2-amino nitrogen atom with alkyl, dialkyl, benzyl or methoxybenzyl groups.
4. By inclusion of the 2-amino nitrogen atom in a cyclic structure.
(iv) Marihuana.
(v) Any material, compound, mixture or preparation which contains any quantity of the following substances, including the salts, isomers and salts of isomers:
1. Methaqualone.
(vi) Gamma hydroxybutyric acid, any salt, hydroxybutyric compound, derivative or preparation of gamma hydroxybutyric acid, including any isomers, esters and ethers and salts of isomers, esters and ethers of gamma hydroxybutyric acid, except gamma-butyrolactone (GBL), whenever the existence of such isomers, esters and salts is possible within the specific chemical designation. For purposes of security requirements imposed by law or regulation upon registered distributors and registered manufacturers, this substance when manufactured, distributed or possessed in accordance with an exemption approved under section 505(i) of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1040, 21 U.S.C.§ 301 et seq.) shall, notwithstanding any other provision of this act, be classified as a controlled substance in Schedule III of this section.
(vii) Synthetic cannabinoids including any material, compound, mixture or preparation that is not listed as a controlled substance in Schedule I through V, is not a Federal Food and Drug Administration approved drug or used within legitimate and approved medical research and which contains any quantity of the following substances, their salts, isomers, whether optical positional or geometric, analogues, homologues and salts of isomers, analogues and homologues, unless specifically exempted, whenever the existence of these salts, isomers, analogues, homologues and salts of isomers, analogues and homologues if possible within the specific chemical designation:
1. Tetrahydrocannabinols meaning tetrahydrocannabinols which are naturally contained in a plant of the genus Cannabis as well as synthetic equivalents of the substances contained in the plant or in the resinous extractives of Cannabis or synthetic substances, derivatives and their isomers with analogous chemical structure and or pharmacological activity such as the following:
(A) Delta-1 cis or trans tetrahydrocannabinol and their optical isomers.
(B) Delta-6 cis or trans tetrahydrocannabinol and their optical isomers.
(C) Delta-3,4 cis or their trans tetrahydrocannabinol and their optical isomers.
2.

Indole carboxaldehydes - Any compound structurally derived from 1H-indole-3-carboxaldehyde or 1H-indole-2-carboxaldehyde:

(A) substituted in both of the following ways:
(I) At the nitrogen atom of the indole ring.
(II) At the carbon of the carboxaldehyde by a phenyl, benzyl, naphthyl, adamantyl, cyclopropyl or propionaldehyde group; and
(B) whether or not the compound is further modified to any extent in any of the following ways:
(I) Substitution to the indole ring to any extent.
(II) Substitution to the phenyl, benzyl, naphthyl, adamantyl, cyclopropyl or propionaldehyde group to any extent.
(III) A nitrogen heterocyclic analog of the indole ring.
(IV) A nitrogen heterocyclic analog of the phenyl, benzyl, naphthyl, adamantyl or cyclopropyl ring.

This shall include AM 1248, AM 2201, AM 679, AM 694, EAM- 2201, FUB-144, JWH 015, JWH 018, JWH 019, JWH 073, JWH 081, JWH 122, JWH 200, JWH 203, JWH 210, JWH 250, JWH 251, JWH 302, JWH 398, MAM-2201, RCS-4, RCS-8, THJ-018, THJ-2201, UR-144, WIN 55- 212, WIN 48-098 and XLR-11.

2.1. Indole carboxamides - Any compound structurally derived from 1H-indole-3-carboxamide or 1H-indole-2-carboxamide:
(A) substituted in both of the following ways:
(I) At the nitrogen atom of the indole ring.
(II) At the nitrogen of the carboxamide by a phenyl, benzyl, naphthyl, adamantyl, cyclopropyl or propionaldehyde group; and
(B) whether or not the compound is further modified to any extent in any of the following ways:
(I) Substitution to the indole ring to any extent.
(II) Substitution to the phenyl, benzyl, naphthyl, adamantyl, cyclopropyl or propionaldehyde group to any extent.
(III) A nitrogen heterocyclic analog of the indole ring.
(IV) A nitrogen heterocyclic analog of the phenyl, benzyl,naphthyl, adamantyl or cyclopropyl ring.

This shall include AB-CHMINACA, AB-FUBINACA, AB-PINACA, ADBICA, ADB-PINACA, AKB-48, AMB, NNEI, STS-135 and THJ.

2.2. Indole carboxylic acids - Any compound structurally derived from 1H-indole-3-carboxylic acid or 1H-indole-2- carboxylic acid:
(A) substituted in both of the following ways:
(I) At the nitrogen atom of the indole.
(II) At the hydroxyl group of the carboxylic acid by a phenyl, benzyl, naphthyl, adamantyl, cyclopropyl or propionaldehyde group; and
(B) whether or not the compound is further modified to any extent in any of the following ways:
(I) Substitution to the indole ring to any extent.
(II) Substitution to the phenyl, benzyl, naphthyl, adamantyl, cyclopropyl or propionaldehyde group to any extent.
(III) A nitrogen heterocyclic analog of the indole ring.
(IV) A nitrogen heterocyclic analog of the phenyl, benzyl, naphthyl, adamantyl or cyclopropyl ring.

This shall include BB-22, 3-CAF, FDU-PB-22, FUB-PB-22, NM2201 and PB-22.

3. Naphthylmethylindoles or any compound containing a 1H- indol-3-yl-(1-naphthyl) methane structure with a 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. This shall include JWH 175 and JWH 184.
4. Naphthoylpyrroles or 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. This shall include JWH 147 and JWH 307.

5. Naphthylmethylindenes or any compound containing a naphthylideneindene 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. This shall include JWH 176.
6.[Deleted by 2016 Amendment.]
7. Cyclohexylphenols or any compound containing a 2-(3- hydroxycyclohexyl) phenol structure with a substitution at the 5-position of the phenolic ring whether or not substituted in the cyclohexyl ring to any extent. This shall include the following:
(A) CP 47,497 and its homologues and analogues.
(B) Cannabicyclohexanol.
(C) CP 55,940.
8.[Deleted by 2016 Amendment.]
9.[Deleted by 2016 Amendment.]
10. Dibenzopyrans or any compound containing a 11-hydroxy- delta 8-tetrahydrocannabinol structure with substitution on the 3-pentyl group. This shall include HU-210, HU-211, JWH 051 and JWH 133.
11.[Deleted by 2016 Amendment.]
12. [Deleted by 2016 Amendment.]
13.[Deleted by 2016 Amendment.]
14. Any other synthetic chemical compound that is a cannabinoid receptor type 1 agonist as demonstrated by binding studies and functional assays that is not listed in Schedules II, III, IV and V, not a Federal Food and Drug Administration- approved drug or not used within legitimate, approved medical research.
(viii) Psychedelic phenethylamines, their analogues, congeners, homologues, isomers, salts and the salts of analogues, congeners, homologues and isomers as follows:
1. 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).
2. 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).
3. 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).
4. 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I).
5. 2-ethanamine (2C-T-2).
6. 2-ethanamine (2C- T-4).
7. 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).
8. 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).
9. 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P).
10. 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25C-NBOMe).
11. 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I-NBOMe).
12. 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25B-NBOMe).
(2) Schedule II--In determining that a substance comes within this schedule, the secretary shall 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:
(i) Any of 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:
1. Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate, including hydrocodone, morphine and oxycodone.
2. Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in subclause 1, except that these substances shall not include the isoquinoline alkaloids of opium.
3. Opium poppy and poppy straw.
4. Coca leaves and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, but shall not include decocainized coca leaves or extracts of coca leaves, which extracts do not contain cocaine or ecgonine.
(ii) Any of 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 such isomers, esters, ethers and salts is possible within the specific chemical designation:
1. Alphaprodine.
2. Anileridine.
3. Bezitramide.
4. Dihydrocodeine.
5. Diphenoxylate.
6. Fentanyl.
7. Isomethadone.
8. Levomethorphan.
9. Levorphanol.
10. Metazocine.
11. Methadone.
12. Methadone-Intermediate, 4-cyano-2-dimethylamino-4, 4-diphenylbutane.
13. Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenyl-propane-carboxylic acid.
14. Pethidine.
15. Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine.
16. Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate.
17. Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid.
18. Phenazocine.
19. Piminodine.
20. Racemethorphan.
21. Racemorphan.
22. Carfentanil.
(iii) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances:
1. Amphetamine, its salts, optical isomers, and salts of its optical isomers.
2. Phenmetrazine and its salts.
3. Methylphenidate.
4. Methamphetamine including its salts, isomers and salts of isomers.
5. Lisdexamfetamine.
(iv) The phrase "opiates" as used in section 4 of this act and elsewhere throughout the act shall not include the dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its salts, but does include its racemic and levorotatory forms.
(v) Any material, compound, mixture, or preparation unless specifically excepted which contains any quantity of:
1. Phencyclidine.
(3) Schedule III--In determining that a substance comes within this schedule, the secretary shall 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 or high psychological dependence. The following classes of controlled substances are included in this schedule:
(i) Any material, compound, mixture, or preparation unless specifically excepted or unless listed in another schedule which contains any quantity of the following substances:
1. Any substance which contains any quantity of a derivative of barbituric acid, or any salt of a derivative of barbituric acid.
2. Chorhexadol.
3. Glutethimide.
4. Lysergic acid.
5. Lysergic acid amide.
6. Methyprylon.
7. Deleted by amendment. 1978, Nov. 26, P.L. 1392, No. 328,§ 1, effective in 60 days.
8. Sulfondiethylmethane.
9. Sulfonethylmethane.
10. Sulfonmethane.
11. Buprenorphine.
(ii) Nalorphine.
(iii) Any material, compound, mixture, or preparation containing limited quantities of the following narcotic drugs, or any salts thereof, unless specifically excepted or listed in other schedules:
1. 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.
2. 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.
3.[Deleted by 2016 Amendment.]
4. [Deleted by 2016 Amendment.]
5. 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.
6. 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.
7. Not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
8. Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams and not more than 2.5 milligrams per dosage unit with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(iv) [Not in original.]
(v) The secretary may by regulation except any compound, mixture, or preparation containing any drug or controlled substance listed in subclauses (i) and (ii) of this schedule above from the application of those provisions of this 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 such admixtures shall be included therein in such 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.
(vi) The secretary shall by regulation exempt any nonnarcotic substance from the control under this act if such substance may, under the provisions of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.), be lawfully sold over the counter without a prescription.
(vii) Anabolic steroid includes any material, compound, mixture or preparation that includes any of the following or any isomer, ester, salt or derivative of any of the following that acts in the same manner on the human body:
1. Chorionic gonadotropin, except when used for injection or implantation in cattle or any other nonhuman species and when that use is approved by the Food and Drug Administration.
2. Clostebol.
3. Dehydrochlormethyltestosterone.
4. Ethylestrenol.
5. Fluoxymesterone.
6. Mesterolone.
7. Metenolone.
8. Methandienone.
9. Methandrostenolone.
10. Methyltestosterone.
11. Nandrolone .
12. [Deleted by 2016 Amendment.].
13. Norethandrolone.
14. Oxandrolone.
15. Oxymesterone.
16. Oxymetholone.
17. Stanozolol.
18. Testosterone.
19. Testosterone-like related compounds.

Human Growth Hormone (HGH) shall not be included as an anabolic steroid under the provisions of this act. An anabolic steroid which is a combination of estrogen and anabolic steroid and which is expressly intended for administration to hormone-deficient women shall be exempt from the provisions of this act. A person who prescribes, dispenses or distributes an anabolic steroid which is a combination of estrogen and anabolic steroids and which is intended for administration to hormone-deficient women for use by persons who are not hormone-deficient women shall be considered to have prescribed, dispensed or distributed an anabolic steroid within the meaning of this subclause.

(viii) Gamma hydroxybutyric acid, any salt, hydroxybutyric compound, derivative or preparation of gamma hydroxybutyric acid, including any isomers, esters and ethers and salts of isomers, esters and ethers of gamma hydroxybutyric acid, except gamma-butyrolactone (GBL), contained in a drug product for which an application has been approved under section 505 of the Federal Food, Drug, and Cosmetic Act.
(ix) Ketamine , any salt, ketamine compound, derivative or preparation of ketamine , including any isomers, esters and ethers and salts of isomers, esters and ethers of ketamine .
(x) Xylazine, including any of the following substances, their salts, isomers and salts of isomers whenever the existence of the salts, isomers and salts of isomers is possible within the specific chemical designation:
1. Xylazine.
2. Xylazine-M (2,6Mich dimethylaniline).
3. Xylazine-M (N-thiourea-2,6-dimethylaniline).
4. Xylazine-M (Sulfone-ho-) isomer 2.
5. Xylazine-M (Ho-2,6-dimethylaline isomer 1).
6. Xylazine-M (Ho-2,6-dimethylaline isomer 2).
7. Xylazine M (oxo-).
8. Xylazine-M (Ho-) isomer 1.
9. Xylazine-M (Ho-) isomer 1 glucuronide.
10. Xylazine-M (Ho-) isomer 2.
11. Xylazine-M (Ho-) isomer 2 glucuronide.
12. Xylazine-M (Ho-oxo-) isomer 1.
13. Xylazine-M (Ho-oxo-) isomer 1 glucuronide.
14. Xylazine-M (Ho-oxo-) isomer 2.
15. Xylazine-M (Ho-oxo-) isomer 2 glucuronide.
16. Xylazine-M (sulfone).
17. Xylazine-M (sulfone-ho-) isomer 1.
18. A compound, mixture or preparation which contains any quantity of the substances referred to in this clause.
(xi) Xylazine as described in subclause (x) is not a controlled substance when used in any of the following manners:
1. Dispensing or prescribing for, or administering to, a nonhuman species of a drug containing xylazine that:
(A) Has been approved by the United States Secretary of Health and Human Services under 21 U.S.C. § 360B (relating to new animal drugs); or
(B) Is authorized under 21 U.S.C. § 360B(A)(4).
2. The manufacturing, distribution or use of xylazine as an active pharmaceutical ingredient for manufacturing an animal drug approved under 21 U.S.C. § 360B or an animal drug that has been issued an investigation use exemption under 21 U.S.C. § 360B(J).
3. The manufacturing, distribution or use of a xylazine bulk chemical for pharmaceutical compounding by a licensed pharmacist or veterinarians.
4. Any other use approved or authorized under 21 U.S.C. Ch. 9 (relating to Federal Food, Drug, and Cosmetic Act).
5. Another use approved or permissible under Federal or State law.
(4) Schedule IV--In determining that a substance comes within this schedule, the secretary shall find: a low potential for abuse relative to substances in Schedule III; currently accepted medical use in the United States; and limited physical and/or psychological dependence liability relative to the substances listed in Schedule III. The following controlled substances are included in this schedule:
(i) Any material, compound, mixture, or preparation, unless specifically excepted or unless listed in another schedule, which contains any quantity of the following substances:
1. Barbital.
2. Chloral betaine.
3. Chloral hydrate.
4. Ethchlorvynol.
5. Ethinamate.
6. Methohexital.
7. Meprobamate.
8. Methylphenobarbital.
9. Paraldehyde.
10. Petrichloral.
11. Phenobarbital.
12. Zopiclone.
13. Carisoprodol.
14. Tramadol.
(ii) The secretary may by regulation except any compound, mixture, or preparation containing any drug or controlled dangerous substance listed in subclause (i) of this schedule above from the application of those provisions of this act 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 such admixtures shall be included therein in such 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.
(iii) The secretary shall by regulation exempt any nonnarcotic substance from the control under this act if such substance may, under the provisions of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.), be lawfully sold over the counter without a prescription.
(5) Schedule V--In determining that a substance comes within this schedule, the secretary shall 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 and/or psychological dependence liability relative to the substances listed in Schedule IV. The following controlled substances are included in this schedule:
(i) Any 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:
1. 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.
2. 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.
3. 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.
4. Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.
5. Not more than 100 milligrams of opium per 100 milliliters or per 100 grams, or not more than 5 milligrams per dosage unit.
6. Pregabalin.
(ii) [Deleted by 2016 Amendment.]
(6) A drug product in a finished dosage formulation that contains 2--5-PENTYL-1,3-BENZENEDIOL that has been approved by the Federal Food and Drug Administration pursuant to section 505 of the Federal Food, Drug and Cosmetic Act prior to the date of enactment shall not be subject to control under this act.

35 P.S. § 780-104

Amended by P.L. (number not assigned at time of publication) 2024 No. 17,§ 1, eff. 5/15/2024.
Amended by P.L. TBD 2020 No. 117, § 1, eff. 11/25/2020.
Amended by P.L. TBD 2018 No. 96, § 2, eff. 10/24/2019.
Amended by P.L. TBD 2016 No. 37, § 2, eff. 8/7/2016.
Amended by P.L. 242 2013 No. 40, § 1, eff. 7/2/2013.
1972, April 14, P.L. 233, No. 64, §4, eff. June 14, 1972. Amended 1978, Nov. 26, P.L. 1392, No. 328, §1, effective in 60 days; 1985 , July 3, P.L. 138, No. 39, § 1, imd. effective; 1989 , Dec. 22, P.L. 700, No. 91, § 1, effective in 60 days; 1989 , Dec. 22, P.L. 750, No. 104, § 1, effective in 60 days; 1996, Dec. 18, P.L. 1096, No. 163, §1, effective in 60 days; 1999, Nov. 24, P.L. 894, No. 55, § 1, effective in 60 days; 2000, Oct. 18, P.L. 601, No. 78, §1, effective in 60 days; 2011 , June 23, P.L. 36, No. 7, § 1, effective in 60 days [Aug. 22, 2011].