Medical Device Link.

Originally Published PMPN November 2001

REGULATORY FOCUS

Rule will help retail pharmacies, which regularly offload work central-fill pharmacies because of pharmacist shortage.

Central-fill pharmacies, which prepare and package prescriptions on behalf of some retail pharmacies, will now be allowed to dispense controlled substances under a new rule proposed by the Drug Enforcement Administration (DEA).

By 2005, U.S. pharmacists expect to fill 4 billion prescriptions annually, an increase of 35% from 1999. But the number of pharmacists is expected to increase only 6% during that time. Therefore, retail pharmacies are seeking new ways to increase efficiency, including transferring some time-consuming, nonclinical duties such as prescription filling to central-fill pharmacies.

DEA regulations did not allow central-fill pharmacies to dispense controlled substances, but the agency plans to change that in order to keep up with "emerging industry practices." A rule proposed in the September 6, 2001, Federal Register (66 FR:46567–46571) would remove that restriction in states where such activities are permitted. "Allowing central-fill pharmacies to fill prescriptions on behalf of retail pharmacies for subsequent dispensing to the ultimate user is a legitimate extension of current practice," the agency states. "It is anticipated that this rule, by affording additional flexibility to pharmacies in the dispensing of prescriptions, will help lower total healthcare costs." Comments were due by November 5.

Central-fill pharmacies would therefore be able to register under 21 CFR 1301.13(e)(1)(iii) to dispense controlled substances to the extent that their activities are authorized in the state in which they are located. The central-fill pharmacy would be allowed to prepare prescriptions for controlled substances in Schedules II–V for dispensing to a patient by a registered retail pharmacy. New prescriptions and refills are both permitted, provided that a licensed pharmacist fills them and all applicable regulations are followed.

The DEA determined that central-fill pharmacy activities are better described as "dispensing" than "distributing," so they will not be limited by the restrictions on distributions from one practitioner to another as set forth in 21 CFR 1307.11. And 21 CFR 1305.13 will be amended to clarify that central-fill pharmacies are not required to fill out official order forms to transfer Schedule II controlled substances to retail pharmacies.

Both the pharmacist who fills the prescription at the central-fill pharmacy and the one who dispenses it to the patient at the retail pharmacy are responsible for ensuring that the prescription is issued for a legitimate medical purpose in accordance with 21 CFR 1306.04(a) and 1306.05(a). Central-fill pharmacies may not dispense directly to a patient or individual practitioner.

The central-fill pharmacy would be required to keep a list of retail pharmacies for which it has agreed to provide these services and to have current copies of the DEA Certificates of Registration for those pharmacies. Likewise, retail pharmacies would have to keep a list of central-fill pharmacies providing these services for them and to maintain copies of their certificates.

Retail pharmacies would be allowed to fax prescriptions for controlled substances to the central-fill pharmacy, in which case the retail pharmacy would be responsible for maintaining the original prescription and the central-fill pharmacy for maintaining the facsimile. Alternatively, retail pharmacies might be allowed to send such prescriptions electronically to central-fill pharmacies. The rule is not proposing specific security standards for this particular situation because there is little risk of diversion, but a separate rulemaking will propose general standards for electronic transmission of prescriptions for controlled substances. If electronic transmission is to be done, all federal and state requirements regarding patient confidentiality, network security, and use of shared databases must be heeded, and both pharmacies must keep the information readily retrievable and comply with all applicable federal and state recordkeeping requirements.

Central-fill pharmacies would be subject to the same security requirements as retail pharmacies that dispense controlled substances, as outlined in 21 CFR 1301.71, 1301.75 and 1301.76. Additional security measures may be necessary, depending on volume of controlled substances handled, number of employees at a site, or other factors. Central-fill pharmacies must take care in choosing carriers to transport prescriptions back to retail pharmacies, and they must report in-transit losses in accordance with 21 CFR 1301.74(e).

The central-fill pharmacy would have to affix to the package a label showing the retail pharmacy's name and address, and the central-fill pharmacy's DEA registration number.

For further information, contact Patricia M. Good, chief, Liaison and Policy Section, Office of Diversion Control, DEA, Washington, DC 20537, 202/307-7297.

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