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Prescribing Regulations

"[F]ederal law categorizes prescription medications into schedules based on their abuse potential. As a result, these drugs need to be handled by prescribers and pharmacists in very specific ways. Schedule II controlled substances, which are generally used for moderate to severe pain, have the most restriction. Prescriptions written for medications listed in Schedule II can only be refilled with a written prescription."
D.J. Pisano "Controlled Substances and Pain Management: Regulatory Oversight, Formularies, and Cost Decisions" 24(4) J. LAW, MED. & ETHICS 310 (1996) [HTML] [PDF]

Federal Statutes and Schedules
Controlled Substances Act, 21 U.S.C. §§ 801 et seq. [Findlaw] [DOJ]

Schedules of Controlled Substances 21 C.F.R. § 1308 [PDF] [LII]

Prescribing Regulations 21 U.S.C. § 829[Findlaw] [LII] $[Lexis] $[Westlaw] places considerable limitations on the non-prescription distribution of most scheduled drugs. Additional and overlapping restrictions are provided for by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 353(b) [Findlaw] [LII] $[Lexis] $[Westlaw].

Pursuant to 21 U.S.C. § 821 [Findlaw] [LII] $[Lexis] $[Westlaw] "The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and to the registration and control of regulated persons and of regulated transactions."
21 C.F.R. § 1306.01 Scope of Part 1306 [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.02 Definitions [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.03 Persons entitled to issue prescriptions [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.04 Purpose of issue of prescription [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.05 Manner of issuance of prescriptions [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.06 Persons entitled to fill prescriptions [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.07 Administering or dispensing of narcotic drugs [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.11 Requirement of prescription [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.12 Refilling prescriptions [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.13 Partial filling of prescriptions [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.14 Labeling of substances and filing of prescriptions [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.21 Requirement of prescription [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.22 Refilling of prescriptions [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.23 Partial filling of prescriptions [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.24 Labeling of substances and filing of prescriptions [LII] $[Lexis] $[Westlaw]
21 C.F.R. § 1306.25 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes [LII]$[Lexis] $[Westlaw]
21 C.F.R. § 1306.26 Dispensing without prescription [LII] $[Lexis] $[Westlaw]

 

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