Norman Clement v. Drug Enforcement Administration
AdministrativeLaw
Whether a pharmacy violates its corresponding responsibility under 21 C.F.R. § 1306.04(a) by being required to operate beyond licensing requirement and training and deny filling prescription(s) for a controlled substance issued by an authorized prescribing provider, for a medical disease purpose(s) where the prescription's legitimacy remains undetermined?
QUESTION PRESENTED On May 25, 2022, a three-judge panel of the United States Court of Appeals District of Columbia DEA Administrator’s decision to revoke Pronto Pharmacy’s DEA registration interpreting 21 C.F.R. § 1306.04(a) to not require evidence of a prescription’s illegitimacy before deciding it was dispensed in violation of the regulation. Under this approach, even if a physician prescribed drugs in a good faith effort to promote a patient’s well-being. This vague regulation is fraught with misconceptions. In Gonzales, the Attorney General thought he could interpret “legitimate medical purpose” under § 1306.04(a). Gonzales v. Oregon, 546 U.S. 243 (2006). The Administrative Court explained, however, he exceeded his limited authority under the Act. Id. More recently, the Court. Ruan v. United States, 597 U.S. ___ (2022) (slip op.). determine to whether “knowingly” applied to “except as authorized” under the CSA brought the regulation back before This Petition raises a fourth misconception. In ignoring Gonzales, the DEA has interpreted “legitimate medical purpose” so that a pharmacy violates its corresponding responsibility whether or not there is evidence of a prescription’s illegitimacy (see APP-25,97). Holiday CVS, Fed. Reg. 62316 (2012). This ultra vires authority has allowed the DEA to discipline pharmacists for failing to resolve “red flags” before filling a prescription. However “red flags” are guidelines created by DEA in which the agency “lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine and further lacks authority to promulgated new regulations regarding the treatment of . pain. (see APP-19-21) See Id. Sadly, when challenged in court, the DEA hides behind the great deference awarded to administrative agencies. This Petition seeks to fight this harmful deference and asks the Court: 1.Whether a pharmacy violates its corresponding responsibility under 21 C.F.R. § 1306.04(a) by being required to operate beyond licensing requirement and training and deny filling prescription(s) for a controlled substance issued by an authorized : prescribing provider, for a medical disease purpose(s) where the prescription’s legitimacy remains undetermined? 2. Whether the record as a whole establishes by a preponderance of the evidence base on an evidentiary standard of “red flag” as a guideline that Pronto Pharmacy's DEA Certificate of Registration Number FP2302076 should be revoked and any pending applications for renewal or modification of such registration and applications for any other pending DEA registrations should be denied pursuant to 21 U.S.C. 824(a) (4) and 21 U.S.C. 823(f)? 3. We further ask this Court to determine whether a Pharmacists refusal to fill a prescription for a “legitimate medical purpose” under the Pharmacists “corresponding responsibility,” provision, constitute and violates the Eight Amendment prohibition against cruel and usual punishment? 4. Whether it was the intent Congress for DEA to regulate the field and practice of medicine and pharmacy auger deference awarded to administrative agencies ?