A substance (which is not included in these lists) may also be regulated as an analogue of a controlled substance. An analogue of a controlled substance is a substance intended for human consumption, structurally similar to a substance in List I or II, pharmacologically substantially similar to a substance in List I or II, or presented as similar to a substance in List I or II, and not a medicinal product authorised in the United States. See 21 U.S.C. §802(32)(A) for the definition of a controlled substance analogue and 21 U.S.C. §813 for guidance. When dispensing List II controlled substances in emergency situations, the following requirements must be met:7 Schedule III and IV controlled substances may not be bottled or refilled more than 5 times or more than 6 months after the date of issue of the order, whichever comes first.3 List II orders cannot be renewed. Under federal law, there is no expiry date for a List II order. However, many states have set time limits. In states without expiration, this becomes a delicate situation and the professional judgment of the pharmacist is extremely important. General information § 1306.01 – Scope of Part 1306. § 1306.02 – Definitions. § 1306.03 – Persons entitled to an order.

§ 1306.04 – Purpose of the limitation period. § 1306.05 – Method of issuing revenues. § 1306.06 – Persons authorized to fill prescriptions. § 1306.07 – Administration or distribution of narcotics. § 1306.08 – Electronic prescriptions. § 1306.09 – Prescription for online pharmacies. Section 812 of the Controlled Substances Act (21 U.S.C. §801 et seq.) (CSA) lists substances that were controlled in 1970 when the CSA came into force. Since then, many substances have been added, removed or transferred from one schedule to another. The current list of controlled substances can be found in § 1308 of the latest edition of Title 21 of the Code of Federal Regulations (CFR) Part 1300 to end (21 CFR §1308) and in the final rules published in the Federal Register after the publication of the cfR.

The CSA also provides a mechanism by which substances can be controlled (added to lists or transferred between lists) or controlled (removed from control). The procedure for these measures is found in section 201 of the Act (21U.S.C. §811). Procedures for adding, removing, or modifying the schedule of a drug or other substance may be initiated by the Drug Enforcement Administration (DEA), the Department of Health and Human Services (HHS), or through a petition from an interested party, including: To determine in which list a drug or other substance should be included, or if a substance should be controlled or reclassified, certain factors must be taken into account. These factors are listed in Section 201(c), [21 U.S.C. § 811(c)] of the CSA as follows: Any drug that is a controlled substance listed in Schedules II, III, IV or V of the Federal Controlled Substances Act or the Regulations may only be dispensed by prescription, as required by Section 503(b)(1) of the Federal Food. Medicines and Cosmetics Act, unless expressly excluded in § 290.2. For the purposes of approving an oral prescription for a controlled substance listed in Schedule II of the Federal Controlled Substances Act, the term “emergency” refers to situations in which the prescriber determines: The requirements for controlled substances have specific requirements. Pharmacists should consult their state rules to determine if there are other prescribing requirements. These lists describe the basic or starting chemical and not the salts, isomers, isomer salts, esters, ethers and derivatives that may be controlled substances. These are not exhaustive lists, so please note that a substance does not need to be added to the list of controlled substances to be treated as a planned substance for law enforcement agencies. The Other Names column contains some examples of alternative names for specific compounds and, in some cases, examples of position isomers.

If external parties want to ensure that a compound is not considered a planned substance or listed chemical, they must write to the DEA, Drug and Chemical Evaluation Section (DRE), Diversion Control Division, 8701 Morrissette Drive, Springfield, Virginia 22152, for a formal determination. (1) Its actual or relative potential for abuse. (2) Scientific proof of its pharmacological action, if known. (3) The state of scientific knowledge about the medicinal product or other substance. (4) Its history and the current pattern of abuse. (5) Scope, duration and significance of the abuse. (6) What, if any, risk to public health? (7) His psychological or physiological responsibility for addiction. (8) If the substance is a direct precursor to a substance already regulated under this subchapter. Pursuant to section 305(c) of the Federal Controlled Substances Act, section 290.5, promulgated under section 503(b) of the Federal Food, Drugs and Cosmetics Act, requires the following warning on the label of certain drugs when they are delivered to or for a patient: “Caution: Federal law prohibits the transfer of this drug to a person other than the patient, The Spanish version of it is as follows: “Précaucion: La ley Federal prohibe el transferir de esta droga a otra persona que no sea el paciente para quien fue recetada.” (b) that no appropriate alternative treatment is available, including the administration of a drug that is not a controlled substance in accordance with Schedule II of the Act, and that pharmacists have a great responsibility to keep abreast of the laws and regulations that govern the profession. The Controlled Substances Act (CSA) classifies all substances controlled under existing federal law in 1 of 5 lists.

In addition, production, procurement and distribution requirements are described, such as records retention regulations. This document is a general reference and not an exhaustive list. This list describes the basic or starting chemical and not the salts, isomers and salts of isomers, esters, ethers and derivatives, which may also be controlled substances. The controlled substances listed in Annexes III and IV expire after 6 months. (a) the immediate administration of the controlled substance is necessary for the appropriate treatment of the intended end-user; and pharmacists should consult their state laws and regulations to determine if there are more stringent requirements for List II oral emergency prescriptions. All prescriptions for controlled substances must include the following:2 List II controlled substances may be issued by oral order in an emergency. Controlled substances listed in Annex II § 1306.11 – Prescription. § 1306.12 – Filling of recipes; Exhibition of several recipes. § 1306.13 – Partial filling of revenues. § 1306.14 – Labelling of substances and filling of recipes. § 1306.15 – Provision of prescribing information between retail pharmacies and central bottling pharmacies for prescriptions of controlled substances in List II.

Prescriptions must be dispensed for legitimate medical purposes, and pharmacists have an appropriate responsibility to determine this when dispensing controlled substances.4 Essentially, this means that pharmacists apply their professional judgment and prescribe must verify the controlled substances. Pharmacists should consult their Prescription Drug Monitoring Program (PDMP) when reviewing prescriptions for controlled substances.