This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Imprimis Optimistic After Congressional Passage Of The Drug Quality And Security Act

SAN DIEGO, Nov. 19, 2013 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (IMMY), a pharmaceutical company focused on commercializing novel drug formulations invented by physicians and pharmacists through their clinical experience with patients, today voiced support for the U.S. Senate's approval of the Drug Quality and Security Act (H.R. 3204), which clarifies and strengthens the regulatory framework for compounding pharmacies.

"Passage of this Bill by the Senate by a voice vote, after the House's approval in September, has the promise of being a good step forward for patients, physicians, pharmacists and third-party payers," said Mark L. Baum, Chief Executive Officer of Imprimis. "The Bill respects the rights of compounding pharmacies to serve their communities in nearly the same way they did prior to the passage of the Bill, while clarifying and strengthening laws related to drug compounding."

The Drug Quality and Security Act, which must be signed into law by President Obama, addresses several public concerns about compounding pharmacies. Importantly, under the Bill a pharmacy engaged in preparing sterile compounded drug formulations may voluntarily elect to register as an "outsourcing facility," a new entity permitted to compound large quantities of drug formulations on the U.S. Food and Drug Administration's drug shortage list, and other formulations compounded with drug substances that are on a "clinical need" list to be established by the FDA, without a prescription, as well as distribute these formulations out of state without limitation. Entities voluntarily registering as outsourcing facilities would be subject to GMP requirements and regular FDA inspection.  The Bill also provides for better communication between state and federal regulators and mandates that drugs prepared by outsourcing facilities bear a label indicating they were compounded. 

Baum continued, "More and more, patients expect personalized medicines or drugs that are specifically designed for their individual needs. Compounding pharmacies, whether in neighborhoods or hospitals across America, deliver personalized medicines ... today.  Our fundamental goal at Imprimis is patient access to personalized medicine, including increasing the number of prescriptions that are compounded. We believe the best way to make this happen is to address perceived quality issues related to compounding and work with the third-party payer market.  While the vast majority of compounding pharmacists operate under the highest of standards and are vitally important to their communities, this Bill takes a positive step in the right direction to encourage increased quality throughout the industry.  If compounding pharmacies embrace the trend towards increasing quality, we believe the result will be more patients gaining access to vitally important compounded drug formulations."

Working alongside leading physicians and compounding pharmacists, Imprimis has acquired intellectual property for proprietary formulations in four key therapeutic areas: Ophthalmology, Wound Management, Urology and Pain. The company plans to begin development and commercialization activities in these areas in 2014, while continuing to advance the expansion of its proprietary compounded drug and drug delivery vehicle formulations.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $94.99 0.00%
FB $99.54 0.00%
GOOG $678.11 0.00%
TSLA $148.25 0.00%
YHOO $26.82 0.00%


Chart of I:DJI
DOW 16,014.38 -12.67 -0.08%
S&P 500 1,852.21 -1.23 -0.07%
NASDAQ 4,268.7630 -14.99 -0.35%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs