FDA has released its Proposed Rule of National Standards for Third-Party Logistics Providers (“3PLs”) and Prescription Drug Wholesale Distributors (“WDDs”). The Drug Supply Chain Security Act (“DSCSA”), enacted back in November 2013, directed FDA to create national licensure standards for wholesale distributors and 3PLs within …
The Justice Department’s Prescription Interdiction and Litigation (PIL) task force strikes again? Not quite yet, but maybe soon, as explained below. The United States filed a Complaint against Texas entities Zarzamora Healthcare LLC, Rite-Away Pharmacy and Medical Supply #2– and its Pharmacist-in-Charge (PIC), and part owner. …
DEA is proposing to amend its regulations to expressly permit the transfer between pharmacies of an initial controlled substance prescription. Currently, DEA regulations do not address transfer of controlled substance prescriptions — whether paper or electronic — between pharmacies for the initial filling of the …
The tale of “David versus Goliath” is never a dull skirmish. This time, “David” consists of a cast of seven compounding pharmacies and their amicus curiae supporters. And the “David” cast of characters has successfully challenged FDA’s promulgation of its final Memorandum of Understanding (“MOU”) …
In the waning days of the Trump administration, the Department of Health and Human Services announced a fairly significant change in addiction medicine policy. The new policy permits physicians (and only physicians) more flexibility to prescribe buprenorphine – a much used and effective drug that …
As we blogged about last week, DEA published its long-anticipated Notice of Proposed Rulemaking (“NPRM”) addressing suspicious orders of controlled substances. The Proposed Rule is intended to (finally) “clarify” the procedures that DEA registrants must follow for what DEA now deems “orders received under suspicious …
Today, more than two years after Congress passed the Preventing Drug Diversion Act of 2018 (PDDA) and after more than a decade of industry requests for regulations addressing the Drug Enforcement Administration’s (DEA) interpretation of suspicious order requirements under 21 C.F.R. § 1301.74(b), DEA has …
Back on August 20, 2020, the Drug Enforcement Administration (“DEA”) issued an Interim Final Rule (“IFR”) purporting to “clarify” certain provisions of the Agriculture Improvement Act of 2018 (“AIA”). As we explained back when Congress passed the AIA in December 2018, the AIA upended the …
On July 29, 2020, DEA published a Notice of Proposed Rulemaking titled, “Reporting of Thefts or Significant Loss of Controlled Substances.” (85 Fed. Reg. 45547 (Jul. 29, 2020)). See Federal Register notice here. As registrants are well aware, the current DEA regulation addressing reporting to …
Notwithstanding FDA’s earlier efforts touting the benefits of outsourcing facility registration, here, there are less than 75 registered facilities. Almost the same number of outsourcing facilities have opened – and shut – their doors since the passage of the 2013 Drug Quality and Security Act …
A little more than ten years ago, on March 31, 2010, the Drug Enforcement Administration published its Interim Final Rule (IFR) with request for comments, titled “Electronic Prescriptions for Controlled Substances” (Docket No. DEA-218, RIN 1117-AA61). The rule became effective June 1, 2010, and is …
Last week FDA published a much needed guidance document addressing compounding by outsourcing facilities of shortage medications for patients confined to hospitals. Yesterday FDA took an unprecedented step (see Section 503A guidance) and recognized, during the COVID emergency (or until FDA withdraws the policy), Section …
FDA issued a much needed guidance document addressing compounding by outsourcing facilities for hospitalized patients during the COVID-19 emergency. Like its other recent guidance documents addressing the COVID-19 pandemic, this guidance sets forth FDA’s temporary policy — for compounding certain drug products for hospitalized patients …
As we stated in our earlier blog post, on November 21, 2019, FDA released another draft guidance addressing compounding of animal drug products from bulk substances. Recall that FDA first released its draft animal drug compounding guidance in 2015 (blogged about here). With the release …
FDA recently released its latest revised draft guidance addressing compounding of animal drug products from bulk substances. This iteration is not only a re-do of the draft guidance that FDA released in 2015 (blogged about here), but it also includes some new concepts such as …
