Stargazer59
Bluelighter
What is XyremÒ
XyremÒ , a central nervous system depressant, is a FDA-approved drug containing GHB with Orphan Drug Status. It is approved to reduce the incidence of cataplexy (weak or paralyzed muscles) and to improve daytime sleepiness in patients with narcolepsy. The FDA approved XyremÒ for marketing and distribution in the United States under Section 505 of the Food, Drug, and Cosmetic Act. As provided for in Title 21, CFR, Section 1308.13(c)(5), any drug containing gamma-hydroxybuturate for which an application is approved under Section 505 of the Federal Food, Drug, and Cosmetic Act, is a Schedule III controlled substance. As such, any authorized persons manufacturing, distributing or dispensing GHB-containing FDA-approved drug products must register in Schedule III, maintain Schedule III security, comply with the labeling requirements of 21 CFR 1302.03-1302.07, comply with all inventory and recordkeeping requirements and comply with all Schedule III prescription requirements.
While XyremÒ is a Schedule III controlled substance, GHB, including its salts, isomers, and salts of isomers, remains a Schedule I drug. Abuse of XyremÒ will be subject to Schedule I criminal sanctions per the "Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000" (PL106-172). Thus, any person who sells, distributes, or gives XyremÒ to someone else, or who uses XyremÒ for purposes other than what it is prescribed for, may be punished under the federal and state law.
http://www.deadiversion.usdoj.gov/pubs/nwslttr/2003winter/
Anyone on this stuff?
XyremÒ , a central nervous system depressant, is a FDA-approved drug containing GHB with Orphan Drug Status. It is approved to reduce the incidence of cataplexy (weak or paralyzed muscles) and to improve daytime sleepiness in patients with narcolepsy. The FDA approved XyremÒ for marketing and distribution in the United States under Section 505 of the Food, Drug, and Cosmetic Act. As provided for in Title 21, CFR, Section 1308.13(c)(5), any drug containing gamma-hydroxybuturate for which an application is approved under Section 505 of the Federal Food, Drug, and Cosmetic Act, is a Schedule III controlled substance. As such, any authorized persons manufacturing, distributing or dispensing GHB-containing FDA-approved drug products must register in Schedule III, maintain Schedule III security, comply with the labeling requirements of 21 CFR 1302.03-1302.07, comply with all inventory and recordkeeping requirements and comply with all Schedule III prescription requirements.
While XyremÒ is a Schedule III controlled substance, GHB, including its salts, isomers, and salts of isomers, remains a Schedule I drug. Abuse of XyremÒ will be subject to Schedule I criminal sanctions per the "Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000" (PL106-172). Thus, any person who sells, distributes, or gives XyremÒ to someone else, or who uses XyremÒ for purposes other than what it is prescribed for, may be punished under the federal and state law.
http://www.deadiversion.usdoj.gov/pubs/nwslttr/2003winter/
Anyone on this stuff?
