Sorry, you need to enable JavaScript to visit this website.

Title: Section 80.3 - Exceptions, reclassification and exemptions of scheduled controlled substances

Effective Date

01/28/2019

80.3 Exceptions, reclassification and exemptions of scheduled controlled substances. (a) Exemptions.

(1) Those nonnarcotic substances listed in section 1308.22 of title 21 of the Code of Federal Regulations, currently and as thereinafter amended, are excepted from the application of sections 3306 and 3319 of the Public Health Law.

(2) Those drugs, which are restricted by law to dispensing on prescription, listed in section 1308.32 of title 21 of the Code of Federal Regulations, currently and as thereinafter amended, are excepted from the application of sections 3306 and 3319 of the Public Health Law.

(3) Those chemical preparations and mixtures listed in section 1308.24 of title 21 of the Code of Federal Regulations, currently and as thereinafter amended, are excepted from the application of sections 3306 and 3319 of the Public Health Law.

(4) The following compounds, mixtures or preparations containing a narcotic antagonist substance having no potential for abuse, and being excepted or exempted from control under the Federal Controlled Substances Act (21 USC 801 et seq.) are excepted from the application of sections 3306 and 3319 of the Public Health Law:

(i) naloxone and its salts; and

(ii) naltrexone and its salts.

(b) Reclassifications.

(1) The following drugs listed in schedule II(c) of section 3306 of the Public Health Law are hereby reclassified as schedule III substances.

 

TRADE NAME OR OTHER DESIGNATION

COMPOSITION

MANUFACTURER OR SUPPLIER

Mediatric-tablets, capsules and liquid

Tablet and capsule: Conjugated estrogens-equine (Premarin (R), 0.25 mg.; Methyltestosterone, 2.5 mg.; Ascorbic Acid (Vit. C) 100 mg. (for capsules, provided as ascorbic acid, 70 mg. and as Sodium ascorbate, 30 mg.); Cyanocobalamin, 2.5 mcg.; Thiamine mononitrate, 10.0 mg.; Riboflavin, 50 mg.; Niacin-amide, 50.0 mg.; Pyridoxine HC1,3.0 mg.; Calc. panto thenate, 20.0 mg.; Ferrous sulfate exsic., 30.0 mg.; Methamphetamine HC1,1.0 mg. Liquid: Premarin (R)(Conjugated estrogens, (U.S.P.),0.25 mg.; Methyltestosterone, 2.5 mg.; Thiamine HC1, 5.0 mg.; Cyanocobalamin, 1.5 mcg.; Methamphetamine HC1, 10 mg.; Alcohol, 15%.

Ayerst

Phelantin-Kapseals

Phenobarbital (1/2gr) 30 mg.; Dilantin (Diphenyl-hydantoin)(11/2gr) 100 mg.; Methamphetamine Hydrochloride2.5 mg.

Parke-Davis

 

 

(2) The following drug classified under schedule I of section 3306 of the Public Health Law is hereby reclassified as a schedule V substance:  a drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols.

 

(c) Exemptions. The following compounds, mixtures or preparations containing an anabolic steroid listed in subdivision (h) of Schedule II of Section 3306 of the Public Health Law have ingredients included therein in such combinations, quantity, proportion or concentration as to reduce substantially the potential for abuse and, therefore, are exempted from the requirements of Public Health Law Article 33:

 

TRADE NAME

COMPOSITION

MANUFACTURER OF SUPPLIER

Estratest

Esterified estrogens (1.25mg); Methyl- testosterone (2.5mg)

Solvay Pharmaceuticals

Marietta, GA

Estratest HS

Esterified estrogens (0.625mg); Methyl-testosterone (1.25mg)

Solvay Pharmaceuticals

Marietta, GA

Premarin with Methyltestosterone

Conjugated estrogens (0.625 mg); Methyl-testosterone (5.0mg)

Wyeth-Ayerst Laboratories

Philadelphia, PA

Premarin with Methyltestosterone

Conjugated estrogens (1.25mg); Methyl-testosterone (10mg)

Wyeth-Ayerst Laboratories

Philadelphia, PA

 

Statutory Authority

Public Health Law, Section 3307

Volume

VOLUME A-1a (Title 10)

up