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03/12/14 - WSPA Commends Federal Legislation Recognizing Pharmacists as Providers

On March 11, 2014, HR 4190 was introduced in the US House of Representatives to recognize pharmacists as providers under Medicare Part B.

The current legislation, introduced by Representatives Brett Guthrie (R-KY), G.K. Butterfield (D-NC), and Todd Young (R-IN), will enable patient access to, and reimbursement for, Medicare Part B services by state-licensed pharmacists in medically underserved communities. Pharmacists, as the most accessible health care professionals, are uniquely positioned to provide patients in medically underserved communities access to health care services that are already within their scope of practice. By providing for a payment mechanism under Medicare Part B, the bill will allow pharmacists to help fill the gaps in care that have been created by shortages of health care professionals and increases in the number of Americans who are now eligible to gain health insurance under the Patient Protection and Affordable Care Act. 

Although provider status has been a profession-wide goal for many years, activity began picking up in early 2013 and have come to a head with the formation of the Patient Access to Pharmacists’ Care Coalition (PAPCC). The coalition currently represents over 20 organizations and is continuing to grow. Members include organizations representing patients, pharmacists, pharmacies, and other interested stakeholders.

This coalition is focused on developing and helping to enact a federal policy proposal that will enable patient access to, and payment for, Medicare Part B services by state-licensed pharmacists in medically underserved communities. Their primary goal is to expand medically underserved patients’ access to pharmacist services consistent with state scope of practice law.

Getting HR 4190 passed may be a long term effort (possibly even multiple years) that will require grassroots advocacy from all pharmacists. Get ready for action alerts asking you to send letters and emails and make phone calls to your legislators! The WSPA will continue to work with our national partners to make sure that you are kept up to date on the progress of HR 4190 and PAPCC. To read the press release from PAPCC, click here:


10/01/13 - House Passage of Drug Quality and Security Act (Federal Compounding Legislation)

The U.S. House of Representatives passed the Drug Quality and Security Act on Saturday, Sept. 28. This legislation addresses pharmaceutical compounding and the prescription drug supply chain.

This bill would:

  • Distinguish compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions.
  • Define the Food and Drug Administration's role in oversight of outsourcing facilities.
  • Offer providers and patients more information about compounded drugs.
  • Clarify current federal law regarding pharmacy compounding.
  • Develop a workable pathway to unit-level tracking.
  • Strengthen licensure requirements for wholesale distributors and third-party logistics providers.
  • Establish nationwide drug serial numbers. 

Full bill text.

Some of the national associations have distributed additional information regarding this Act. For your convenience, we have provided briefs and links to this information for your viewing.


ASHP Statement on Draft of Drug Quality and Security Act

“Overall, ASHP is supportive of this proposal. The addition of the outsourcing facility category will help promote the safety of products that health care providers and the public receive from compounding outsourcers,” said ASHP CEO Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP. “However, we were disappointed that the bill did not go further to require compounding outsourcing facilities to register with the FDA, and create clearer risk-based criteria to help the FDA identify outsourcers that are operating outside the scope of traditional pharmacy compounding.”
View full text.


NCPA's Analysis of the Drug Quality and Security Act

This analysis is specific to Title I of the Act which addresses pharmaceutical compounding of human drugs and provides a myth and fact sheet.
View full text. (This information is limited to NCPA member only and login is required to access the document.)


NACDS Expresses Support for Congressional Agreement on Comprehensive Supply Chain and Compounding Legislation

NACDS endorses the act and states the legislation will make strong efforts to ensure the health and safety of the American public. They specifically note that the act establishes one national standard for supply chain regulation as opposed to an unworkable patchwork of state laws and regulations.
View full text.


HR 3204 the Drug Quality and Security Act: What Does It Say? What Does It Mean? What Happens Now?

IACP breaks down the compounding section of this Act and highlights several sections that raise concern for them.
View full text.


PCCA Response to HR 3204

PCCA believes the bill could have unintended consequences; however, they also believe opposing or delaying the bill would give other interests the opportunity to negatively influence the bill even further. Therefore, PCCA has decided to be neutral regarding the "Drug Quality and Security Act."
View full text.

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