Posts tagged DEA
DEA Establishes Final Rule on E-Prescribing of Controlled Drugs
Aug 6th
The Drug Enforcement Administration (DEA) has announced its interim final rule for electronic prescribing of controlled substances. The rule became effective on June 1, 2010, and it may be amended in the future depending on public comment.
Pharmacy organizations have been working with the DEA for more than a decade to draft rules for electronic prescriptions of controlled substances. According to the American Pharmacists Association (APhA), e-prescribing for controlled substances will likely not happen for at least another year. Nonetheless, the proposed rules are practical for pharmacists, prescribers and the DEA.
The DEA’s new rule manages electronic prescribing for both controlled and non-controlled pharmaceutical products, whereas before pharmacies were required to keep a paper-and-fax workflow for prescribing controlled substances. The rule also reduces the electronic record-keeping requirement from 5 years to 2 years and eases verification procedures.
Prior to the release of the DEA’s final rule, federal regulations prohibited the use of e-prescribing for controlled substances due to abuse and security concerns. The rule takes the first step in alleviating what many saw as a substantial impediment to the adoption of e-prescribing. Accordingly, the rule is expected to increase the number of providers adopting healthcare IT systems.
Some obstacles that will have to be overcome in e-prescribing for controlled substances are verifying digital signatures, standardizing procedures to change the strength (or any element) of a prescription and standardizing procedures to transfer prescriptions. The DEA will also need to establish whether it will standardize identifiers that prescribers use to write prescriptions for controlled substances.
For more detailed information on the DEA’s new rule, please click here.
President Signs Online Pharmacy Consumer Protection Act
Oct 17th
Last week, we explored the details of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which was passed by the House of Representatives on September 23, 2008 and approved by the Senate on September 30, 2008. Yesterday, the President signed this bill into law.
As a quick recap, the new law proscribes the sale or distribution of any controlled substances via the Internet unless supported by a valid prescription. It also requires that a healthcare provider conduct an in-person examination of the patient in order for a prescription to be deemed valid.
Finally, the new law requires online pharmacies to provide certain disclosures on their websites, comply with all controlling state laws and provide notice to the Attorney General prior to offering to sell, deliver, distribute, or dispense controlled substances over the Internet.
For more information regarding the new law, visit: http://www.govtrack.us/congress/billtext.xpd?bill=h110-6353.
Disclaimer: The information contained within the MTBC® Learning Center is provided for general educational and informational purposes only and should not be construed as legal advice. The author of the Learning Center does not represent the Web site user or the individual submitting a particular question. Please seek the advice of legal counsel to address any specific questions you may have regarding your particular facts or circumstances
US Lawmakers Seek to Regulate Online Pharmacies
Oct 8th
Earlier this week, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was presented to the President for his signature.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 is aimed at regulating the online pharmacies that have proliferated during the last five years. In particular, the Act would require each online pharmacy to do the following:
- Include a statement on its homepage that it complies with the requirements of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008;
- Post information on its homepage regarding its business and operations including its legal name, address, telephone number, the qualifications of its pharmacist-in-charge, and a certification of its registration under this Act ;
- Comply with all controlling state laws regarding the licensure of pharmacies in each state in which it operates or sells controlled substances; and
- Notify the Attorney General and applicable state boards of pharmacy at least 30 days prior to offering to sell, deliver, distribute, or dispense controlled substances over the Internet.
Most importantly, the Act would prohibit online pharmacies from filling any prescriptions unless they are “valid prescriptions.” A “valid prescription” is one that is issued for a legitimate medical purpose by a licensed practitioner who has conducted at least one in-person medical evaluation of the patient.
Finally, the Act creates additional penalties for online pharmacies that do not comply with the same and gives new authority to the attorney general.
Disclaimer: The information contained within the MTBC® Learning Center is provided for general educational and informational purposes only and should not be construed as legal advice. The author of the Learning Center does not represent the Web site user or the individual submitting a particular question. Please seek the advice of legal counsel to address any specific questions you may have regarding your particular facts or circumstances