24 Del. Admin. Code §§ 2500-6.0
Current through Register Vol. 27, No. 12, June 1, 2024
Section 2500-6.0 - Pure Drug Regulations"Central Nervous System" Central nervous system stimulants are drugs which increase the activity of some portion of the brain or spinal cord. Drugs which act upon the cerebral cortex and subcortical structures including the thalamus (e.g. methylphenidate, etc.) increase motor activity and enhance mental alertness; those which act upon the sensory areas in the brain (e.g. caffeine and its various combinations) increase alertness, brighten spirits and combat mental fatigue; those which act directly or reflexly on the medulla (e.g. nikethamide, pentylenetetrazol and picrotoxin) stimulate the respiratory center; those which act on the spinal cord (e.g. nux vomica and strychnine) facilitate and exaggerate spinal reflexes.
6.2 The Delaware State Board of Pharmacy hereby adopts the rules and regulations officially prescribed for the enforcement of the Federal Food, Drug and Cosmetic Act and Acts amendatory thereof, as far as applicable. This regulation is promulgated to comply with directive in Title 16 Del.C. § 3315 paragraph b.6.3 Anyone who repacks and labels drugs in convenient quantities for their own subsequent use must maintain a log on the premises showing the date prepacked, the quantity prepacked, the control number, expiration date and name and strength of the drug. Prepacking must be done under the supervision of a registered pharmacist or any other person authorized to dispense under 24 Del.C. § 2513. Each container must have a label containing the name of the drug, its strength, the manufacturer's control number, the expiration date if applicable, the name of the manufacturer, or the name and strength of the drug and a conference code number which would enable the control number, manufacturer and expiration date to be retrieved from the log. Nothing in this regulation precludes the Federal laws and regulations. 6.3.1 Beyond use date for single unit and unit dose containers. The beyond use date for these products shall be one year or less, unless the stability data or the manufacturer's labeling indicates otherwise. To use this date, the dispenser repacking the product must maintain the facility and packaging at controlled room temperature not to exceed 25°C. The plastic material used for repacking must provide better protection against moisture permeation than polyvinyl chloride.6.4 All biologicals, vaccines, drugs, chemicals, preparations and compounds must be packaged, labeled, stored and preserved in compliance with USP/NF and all other State and Federal standards. A pharmacist may, with the permission of the patient or the patient's agent, provide a "Customized Patient Medication Package" . The containers shall meet all of the requirements of the USP/NF standard entitled, "Customized Patient Medication Package." Packaging of controlled substances in a "Customized Patient Medication Package" is prohibited.6.5 Labeling of Over-the-Counter Central Nervous System Stimulants. Over-the-counter central nervous system stimulants must be labeled and packaged in compliance with state and federal requirements.6.6 Over-the-Counter Medication - Over-the-counter drug is one that can be legally sold without a prescription.NOTE: The only over-the-counter products which currently can be labeled, advertised promoted, marketed or sold as a stimulant are those that do not contain any active ingredient but caffeine.
24 Del. Admin. Code §§ 2500-6.0
4 DE Reg. 1502 (3/1/01)
17 DE Reg. 653 (12/1/2013) (Final)