Overview of Drug Control: A Regulatory Primer on Scheduling and Controlled Substance Regulations

Abstract

For new chemical entities, assessing a compound's abuse potential is an important component of the drug development process. To ensure regulators make the correct evaluation of a compound's abuse liability, it is vital for pharmaceutical companies to understand the appropriate preapproval measures for assessing a new chemical entity's abuse potential and the required registration procedures for making the recommendation. The goal of this review is to present an overview of the scheduling process as it relates to drug development and marketing registration.

Key words: :

• Abuse Potential
• Abuse Liability
• Drug Scheduling
• Controlled Substances
• Drug Development
• Review

Notes

¹Lunesta™ (eszopiclone) marketed by Sepracor was approved by FDA on 15 December 2004, and final scheduling was determined on 4 April 2005. Lyrica® (pregabalin) marketed by Pfizer was approved on 30 December 2004, and a final scheduling decision was determined on 28 July 2005.

²For purposes of the remainder of this article, the term “drug” shall imply only articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man as defined in the Federal Food Drugs and Cosmetic Act 1938 (and amendments), 201(g)(1)(b), i.e. pharmaceuticals. For those chemicals that are not being developed or currently subject to an NDA and thus intended to only be used for illegal means, the term “illicit substance” will be used.

³Draft Guidelines for Abuse Liability Assessment (1 October 1997, 2 December 1998). As of October 2006, FDA has yet to publish final guidelines for abuse liability assessment. Sponsors are encouraged to request meetings with the Controlled Substance Staff on a case-by-case basis for feedback and guidance in drug development programs involving abuse liability assessments.

⁴The problems with Rohypnol (flunitrazepam) and GHB (gamma hydroxybutyrate) are two recent examples of this situation.

⁵For two drugs approved at the end of 2004 (Lunesta™ and Lyrica®), the time from FDA approval to DEA scheduling was 106 and 210 days, respectively.

[1] Code of Federal Regulations, Title 21, Part 314.50.

[2] Code of Federal Regualtions, Title 21, Chapter 13, Subchapter I, Part A, Section 801, (2).

[3] Pure Food and Drug Act, 34 Stat. 768, 1906.

[4] Pure Food and Drug Act, 34 Stat. 768, 1906, Section 7.

[5] Pure Food and Drug Act, 34 Stat. 768, 1906, Section 8.

[6] 21 U.S.C. 352(d), Section 502(d) repealed, February 19, 1998.

[7] 21 USC 801, Pub. L. 91–513, title II, Sec. 101, Oct. 27, 1970, 84 Stat. 1242. and 21 USC 801a, Pub. L. 95–633, title I, Sec. 101, Nov. 10, 1978, 92 Stat. 3768; Pub. L. 96–88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695.

[8] 21 USC 801, Pub. L. 91–513, title II, Sec. 101, Oct. 27, 1970, 84 Stat. 1242.

[10] Code of Federal Regulations, Title 21, Section 811(a).

[11] Code of Federal Regulations, Title 21, Section 812(b).

[12] Code of Federal Regulations, Title 21, Section 811(c).

[13] Code of Federal Regulations, Title 21, Part C.

[14] Code of Federal Regulations, Title 21, Section 822.

[15] Code of Federal Regulations, Title 21, Section 826.

[16] Code of Federal Regulations, Title 21, 829(a) and 829(b).

[26] Code of Federal Regulations, Title 21, 312.21(a).

[27] Code of Federal Regulations, Title 21, 312.21(c).

[28] Code of Federal Regulations, Title 21, 314.50(5)(vii).