This has nothing to do with OPK or Rayaldee. It's the 3rd party manufacturer. I wouldn't be too concerned about it... It was likely due to an audit that needs to fulfill some corrective actions on the production lab. It's annoying that this nuisance is slightly delaying Rayaldee production, but everything else is on track. Huge buying opportunity this morning.
It's time to back up the truck and seriously load up on this morning's pullback. Rayaldee has been approved and will hit the main market. The 3rd party manufacturer issue is a blimp on the radar and represents a huge buying opportunity.
Effective March 14, 2016, state law restricts the supply of opioids that may be prescribed in certain circumstances and provides patients the option to request that a pharmacy filling a prescription for an opioid dispense less than the fully prescribed amount.
1. 7 Day Restriction on the supply of opioids that may be prescribed.
Effective immediately Massachusetts law establishes a maximum seven day supply on prescriptions for opioids when issued to an adult for the first time. The law also sets a maximum seven day supply on all opioid prescriptions for minors.
A prescriber may issue a prescription for more than a seven day supply of an opioid to adult or minor patients if, in the prescriber’s medical judgment, a greater supply is necessary to treat an acute medical condition, chronic pain, pain associated with a cancer diagnosis or for palliative care. In such a case, the condition must be documented in the patient’s medical record and the prescriber must indicate that a non-opioid alternative was not appropriate to address the medical condition.
This new law does not apply to opioid medications that are designed for the treatment of substance abuse or opioid dependence.
2. Partial fill of opioids at patient’s direction
Massachusetts law enables patients to direct pharmacies to dispense less than the fully prescribed quantity of an opioid. If dispensed in this manner, the prescription is void as to any quantity not dispensed.
Prescriber: Whenever a prescriber issues a prescription for an opioid contained in Schedule II, he or she must:
(1) Consult with the patient regarding the quantity of the opioid prescribed and the patient’s option to fill the prescription in a lesser quantity; and
(2) Inform the patient of the risks associated with the opioid prescribed.
Patient: A patient must request that the dispensing pharmacy dispense less than the fully prescribed quantity if they want a lesser amount
Pharmacist: Whenever a patient requests that the pharmacy dispense less then the fully prescribed quantity, the pharmacist must:
(1) dispense as directed
(2) notify the prescriber of the quantity actually dispensed by:
· entering a notation in the patient’s electronic health record;
· faxing or electronically transmitting the notification to the prescriber; or
· making a notation in the patient’s pharmacy record, provided that this record is accessible by the prescriber