IACP Offices Will be Closed on Memorial Day, May 25th
The IACP Offices will be closed on Monday, May 25th in observance of Memorial Day. We will return on Tuesday morning. Wishing you, your family and staff a peaceful Memorial Day.
Legislation to be Filed this Week Addressing DQSA, Office Use and MOU
IACP is very excited to announce that thanks to its efforts and the hard work of the FIX DQSA stakeholders' coalition, legislation will be filed by the end of this week addressing the Drug Quality & Security Act (DQSA) specifically in regards to office-use as well as the MOU.
IACP along with several other medical/practitioner and pharmacy organizations have been working for months to address issues on how DQSA is being implemented without taking Congressional intent into account.
This legislation is a positive move that will help us protect patient access to the compounds on which they depend.
We will announce legislation specifics as soon as they are made public this week.
IACP Comments on FDA Guidance Documents
IACP will be filing comments on the FDA Guidance Documents with the Agency by their Wednesday, May 20th at Midnight newly extended deadline. Stay tuned to IACP's Breaking News/Website Homepage for our final comments as soon as available.
The U.S. Food & Drug Administration (FDA) has established a public docket to receive information, recommendations, and comments on matters related to the Agency’s regulation of compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
This docket is intended for general comments related to human drug compounding that are not specific to documents or issues that are the subject of other dockets. So, while IACP and compounders can submit comments on the draft guidance documents that are directly related to repackaging, adverse event reporting, and the Memorandum of Understanding there has been no place where physicians, patients, pharmacists and others can voice our concerns about office-use.
If office-use is important to your practice or your prescriber clientele, this public docket is the perfect place to file your comments about how the FDA is ignoring Congressional intent and disregarding state laws and regulations permitting office-use.
FDA Public Docket
IACP Members! Click here to access the FDA Public Docket, which includes comment submission instructions.
Make your voice heard! Let the FDA know of your concerns on the recent compounding implementation plan.
IACP Summary on FDA Four Draft Guidance Documents and MOU
Please click here to view.
Louisiana Model of Marketing Oversight Bill Passes House
Louisiana House Bill 568, introduced by state Representative Ledricka Thierry, passed on May 14, 2015, in the Louisiana House of Delegates, unopposed 94-0, with 20 co-authors.
HB 568 enables the Louisiana Board of Pharmacy to investigate and take disciplinary action against a pharmacy that has financial arrangements with doctors and other prescribers that jeopardize patients' freedom-of-choice and could lead to increased health care billings.
The International Academy of Compounding Pharmacists (IACP) and its board endorsed this legislation, with David G. Miller, IACP Executive Vice President and CEO, presenting pharmacy's perspective before the Louisiana House of Delegates two weeks ago.
Adds, Mr. Miller in a press release on May 12th, "As the professional organization representing compounding pharmacists in Louisiana and nationwide, IACP has serious concerns about recent financially motivated marketing schemes that are apparently aimed at taking advantage of patients. These schemes are led by third-party marketing companies, not pharmacists, and they are not representative of the compounding profession. They add unnecessary cost and can compromise patient health. They are detrimental to the vital health care services we provide every day.
We hope the newly passed Louisiana bill will serve as a model for other states."
The proposed bill is scheduled to go before the Louisiana Senate this week.
Please click here to read IACP's press release (May 12th) regarding HB 568.
Tricare Implements Extensive New Restrictions
Effective May 1, Tricare pharmacy contractor Express Scripts began screening each ingredient in compound medications to ensure all are approved by the Food and Drug Administration.
• The average cost for a compound drug has risen from $192 per claim in Dec. 2012 to $2,595 per claim in Dec. 2014, an increase of 1,252%.
• Compound prescriptions account for 0.5% of all DoD prescription volume – compound prescriptions account for over 20% of the total DoD pharmacy costs.
• Compound medications are prescribed for approximately 40,000 of our 9.5 million beneficiaries (0.4% of our total population).
• On 01 May 2015, the Department implemented an automated screening and Prior Authorization process through Express Scripts, Inc. (ESI), the TRICARE pharmacy contractor.
• The new measures temporarily decreased compound prescriptions related costs by approximately 74% based on the previous month. However, even at that reduced level, the Department’s compound prescription expenditures will still average approximately $145 M per month ($1.7B annually).
• Some compound pharmacies appear to be adjusting their activities and claims to elude the newly implemented controls, and work around the screening process. The initial evidence based on five days of data strongly suggests compounds with dubious clinical evidence and excessive cost continue to impact the system and warrants the implementation of additional administrative controls at the point of service (i.e., interaction with the pharmacy).
Please click here to read more.
IACP quoted in Wall Street Journal Blog: "Drug Costs Rose Faster Than Ever for Many Americans: Report." Please click here to read.
FDA Announces CPG on Veterinary Compounding
This morning, the FDA announced its intent to published a draft guidance document for veterinary compounding. This draft, a copy of which is linked here, will replace the previous 2003 compliance policy guidance. The previous guidance has now been formally rescinded.
This draft guidance is of significant concern. We'll be compiling a summary of the primary points for our membership just as we did for the four guidance documents due for comment this week but here's some of our "first impression" observations from the first two reviews:
•All compounds must be for an individually identified animal. No provisions for office-use.
•Anticipatory compounding is limited to 14 days
•FDA is permitting 503B outsourcing facilities to produce veterinary products
•Mandatory adverse event reporting
•Additional, specific labeling requirements (non-food species)
•Mandatory language on prescription requiring that no FDA alternative exists.
•There will be a limited number of bulk ingredients that may be used to compound by 503B outsourcing facilities.
As written, this draft would significantly and negatively impact veterinary compounders. IACP is carefully reviewing these documents, and will be making comments to the FDA. We will share those with our membership as soon as they are available.
IACP and National Pharmacy Associations Protest eLabeling Requirements
IACP, in collaboration with the Academy of Managed Care Pharmacy (AMCP), National Alliance of State Pharmacy Associations (NASPA), National Association of Chain Drug Stores (NACDS), and the National Community Pharmacists Association (NCPA), today submitted formal comments on a proposed Food and Drug Administration (FDA) plan to require pharmacists to take on the cost and responsibility of providing package inserts and patient package inserts. This is part of a FDA's Proposed Rule to Require the Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products [Docket No. FDA–2007–N–0363]
This information is currently distributed in paper form on or within the package from which the product is dispensed. In the proposed rule, the FDA makes it clear that pharmacies will incur net costs due to initial capital costs to access the information, increased search time when accessing the information and the printing cost when a request is received for the information in printed form. The FDA estimates the annualized costs range from $47 million to $89 million and are a shift from manufacturers to pharmacies.
Please click here to read the submitted joint letter.
LAST CALL: Comment Period Ends on May 31st for USP's Revised Chapter of the Proposed <800>
The United States Pharmacopeial Convention (USP) announces that the revised chapter of the proposed <800> is now posted on the USP website. Please click here to review.
The chapter will still be proposed in the Pharmacopeial Forum 41(2) in Mar/April 2015. The comment period for this chapter will end on May 31st, 2015.