Allowing central fill pharmacies and retail pharmacies to fill prescriptions for controlled substances on behalf of retail pharmacies. Final rule.
DEA is finalizing a Notice of Proposed Rulemaking (NPRM) defining central fill pharmacy activities and permitting central fill pharmacies to prepare controlled substances prescriptions on behalf of retail pharmacies with which the central fill pharmacies have a contractual agreement to provide such services or with which the pharmacies share a common owner. When one retail pharmacy receives a prescription and a second pharmacy prepares and subsequently delivers the controlled substance medication to the first retail pharmacy for dispensing to the patient, the second pharmacy is engaging in a "central fill activity". Records must be maintained by both the central fill pharmacy and the retail pharmacy that completely and accurately reflect the disposition of all controlled substance prescriptions dispensed. With respect to security, central fill pharmacies would be required to comply with the same security requirements applicable to retail pharmacies including the general requirement to maintain effective controls and procedures to guard against theft and diversion of controlled substances. DEA is creating an allowance for retail pharmacies that also perform central fill activities to do so without separate DEA registration, separate inventories, or separate records. This rulemaking is sought by the regulated industry and will allow for more efficient delivery of controlled substance prescriptions to patients.
D003284:Contract Services / Q000331:legislation & jurisprudence; D011307:Drug Prescriptions; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D005568:Forms and Records Control; D006801:Humans; D007885:Legislation, Pharmacy; D010594:Pharmacies / Q000331:legislation & jurisprudence*; D014481:United States