Pharmacy Regulations

Operating a pharmacy means adhering to a wide set of federal and state regulations governing everything from customer privacy to the physical layout of your facility. Pharmacies have to stay up to date on these regulations or they could face steep penalties.

At PRS, we aim to make it easier for you to track the constant changes and additions to federal pharmacy regulations. We update the page regularly and will alert you to recent changes. So you can be confident that we have the most up-to-date information.

Making sure you have accurate and up-to-date information on pharmacy regulations is just one way that PRS is committed to helping pharmacy owners succeed. Our regulations page is a critical resource for pharmacies everywhere, and will help you react to pertinent changes before it is too late.

URGENT NOTICE FOR PHARMACIES NOT ALREADY ACCREDITED

With the enactment of Section 3109 of the Patient Protection and Affordable Care Act (PPACA) on March 23, 2010, all pharmacies, unless they qualify for an exemption, must be accredited for the products and services listed on their Medicare enrollment application (CMS-855S) no later than January 1, 2011.

Those suppliers not accredited in time may wish to submit an amended CMS 855S to Palmetto, listing only those products that can be provided as non-accredited suppliers, prior to January 1, 2011.

Contact Palmetto with any questions. PRS and its affiliate, NASI, cannot offer any advice on the process or timing of amending your CMS 855S. Whether you amend your 855S and/or when you send it are business decisions you make. Palmetto's toll-free number is 866-238-9652. [Note: If the 855S you have on file with Palmetto is not up-to-date, you may need to submit a complete 855S form. Again, ask Palmetto.]

Do Not Wait. Take action now to start the accreditation process. Pharmacies subject to accreditation should begin the accreditation process as soon as possible, as it could take up to nine months to complete the accreditation process (according to the information published on the Palmetto GBA website).

We cannot stress this enough, from past experience we know that waiting until the last minute of any deadline is extremely risky.

NASI, a PRS affiliate, can assist you with your accreditation needs. Please contact them at 1-866-606-3211 for more information regarding this issue or to begin the accreditation process.

New Requirement for Community Pharmacies Begins February 2010
The Consumer Product Safety Improvement Act

The Consumer Product Safety Improvement Act (CPSIA) is a NEW LAW, which was signed in 2008.  The Act, which is overseen by the Consumer Product Safety Commission (CPSC), requires testing and documentation of a variety of consumer products, including the CERTIFICATION OF POISON PREVENTION PACKAGING of certain drugs. See how this affects community pharmacies. [READ MORE]

Pennsylvania State Board of Pharmacy (PSBOP)
Important Regulation Changes

The PA Bulletin, dated December 26, 2009, indicated that a number of general revisions to the PSBOP regulations hav been made. The highlighted changes are as follows:

• A pharmacy intern may accept and transcribe telephone or oral orders under the supervision of a pharmacist
• Amended Wording: C-II controlled substances security requirements
• Wording Added: In lieu of original prescriptions, readily retrievable images of original prescriptions can be kept
• Language Clarification regarding: C-II's not being filled more than 6 months from date of prescription
• The mailing of drugs are permissible if appropriate temperature controls and sensors are utilized
• NO controlled substances may be promoted for sale
  • Note: Previous wording indicated that only C-II's were banned
• Prospective Drug Review (PDR) is required for prescriptions and drug orders

To review these changes, please go to the following link:

www.pabulletin.com/secure/data/vol39/39-52/2369.html

Please Note: These changes have not been incorporated on the state regulation portion of the website yet.