By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
By Larry K. Houck – Prescriptions issued for controlled substances must contain the patient’s name and address; the drug name, strength and dosage form; the quantity prescribed; directions for use; and the practitioner’s name, address and Drug Enforcement Administration (“DEA”) registration number. DEA advised in its …
By Karla L. Palmer – The Energy and Commerce Committee’s Subcommittee on Health (chaired by Representative Joe Pitts (R-PA)), has scheduled a hearing for Monday, April 7, 2014, at 3:00 p.m. in room 2123 of the Rayburn House Office Building. The hearing is titled “Improving Predictability and …
By John A. Gilbert, Jr. – A new bill introduced in Congress, H.R. 4299 (titled “Improving Regulatory Transparency for New Medical Therapies Act”), would significantly streamline the drug scheduling process for new medical therapies and reduce the potential for unnecessary delays in the availability of these needed …
By John A. Gilbert, Jr. & Larry K. Houck – A bill introduced in the Maryland House of Delegates, HB 0596, would require wholesale distributors to notify their pharmacy customers at least thirty days prior to “imposing a limit on the quantity” of prescription drugs or …
By Delia A. Deschaine & Larry K. Houck – In just shy of three months following receipt of the Department of Health and Human Services (“HHS”)’s rescheduling recommendation, see prior post here, DEA announced the issuance of a Notice of Proposed Rulemaking (“NPRM”) Thursday to reschedule all …
By Karla L. Palmer – Last week, the United States District Court for the District of Oregon ruled that the Drug Enforcement Administration’s (“DEA”) administrative subpoena powers are not unfettered when it comes to obtaining protected health information (“PHI”) submitted by pharmacies to Oregon’s Prescription Drug …
By John A. Gilbert & Delia A. Deschaine – As previously reported here, late last year, CDER Director, Janet Woodcock issued a statement indicating FDA’s intent to recommend that DEA reclassify hydrocodone-combination products in Schedule II. (We note that scheduling recommendations are made to DEA by …
By Larry K. Houck – The National Association of Boards of Pharmacy (“NABP”), along with a coalition of healthcare stakeholders, recently announced collaborative steps to address prescription drug abuse and practitioner compliance with federal and state corresponding responsibility requirements while ensuring that patients receive needed medical …
By Larry K. Houck – Representative Bill Johnson (R-Ohio) introduced a second bill in Congress that seeks to curb abuse of dextromethorphan by teenagers. Johnson introduced the Preventing Abuse of Cough Treatments of 2014 Act (“PACT Act”) last week. The PACT Act, H.R. 3969, co-sponsored by …
By Delia A. Deschaine – Various members of industry recently joined together in filing a citizen petition with FDA. Citizen Petition, Docket No. FDA-2013-P-1711 (hereinafter “Citizen Petition”). The Citizen Petition responds to a statement made by CDER Director, Janet Woodcock, M.D. in October 2013 that FDA intends …
By Delia A. Stubbs – Pursuant to 21 U.S.C. § 811(h), DEA may temporarily place substances in Schedule I of the List of Controlled Substances upon a finding that such action is necessary to avoid an imminent hazard to public health and safety. Using that authority, …
By Delia A. Stubbs & John A. Gilbert – DEA didn’t waste time during its Thanksgiving break. Monday, in just shy of three weeks of the close of its comment period on its proposed rule, DEA issued a final rule placing perampanel in Schedule III. We …
The American Conference Institute will be holding its inaugural forum on controlled substances in Washington, D.C. from Thursday January 16 to Friday, January 17, 2014. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s John A. Gilbert will be …
By John A. Gilbert & Delia A. Stubbs – In a decision published this week, DEA denied an application for a pharmacy registration on the basis that the owner-pharmacist had previously ignored “red flags” and generally failed to exercise her corresponding responsibility in filling prescriptions. Wheatland …
