Upon a request by the Secretary or other appropriate Federal or State official, in the event of a recall or for the purpose of investigating a suspect or an illegitimate product, a dispenser shall, not later than 2 business days after receiving the request or in another such reasonable time as determined by the Secretary, based on the circumstances of the request, provide the applicable transaction information, transaction statement, and transaction history which the dispenser received from the previous owner, which shall not include the lot number of the product, the initial transaction date, or the initial shipment date from the manufacturer unless such information was included in the transaction information, transaction statement, and transaction history provided by the manufacturer or wholesale distributor to the dispenser.

Beginning July 1, 2015, a dispenser— (I) shall not accept ownership of a product, unless the previous owner prior to, or at the time of, the transaction, provides transaction history, transaction information, and a transaction statement; (II) prior to, or at the time of, each transaction in which the dispenser transfers ownership of a product (but not including dispensing to a patient or returns) shall provide the subsequent owner with transaction history, transaction information, and a transaction statement for the product, except that the requirements of this clause shall not apply to sales by a dispenser to another dispenser to fulfill a specific patient need; and (III) shall capture transaction information (including lot level information, if provided), transaction history, and transaction statements, as necessary to investigate a suspect product, and maintain such information, history, and statements for not less than 6 years after the transaction.

Effective October 9th, 2014 the DEA will allow certain authorized registrants, including: manufacturers, distributors, reverse distributors and retail pharmacies to voluntarily administer controlled drug mail-back programs and maintain collection receptacles.

Effective October 6, 2014, Hydrocodone Combination Products (HCPs) will be schedule II substances under the Controlled Substances Act (CSA). For prescribers, the change primarily means that they may not authorize refills for any HCP prescriptions. However, they may issue multiple prescriptions authorizing a patient to receive a total of up to a 90-day supply of HCPs (if state law permits). DEA is allowing HCP prescriptions issued before October 6, 2014 that authorize refills to be refilled until April 8, 2015.

The U.S. Food and Drug Administration has issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013.

This week CMS released the final regulation addressing changes in the Medicare Part D Prescription Drug Program. The most beneficial change for pharmacy was found in Section 18: Prescription Drug Pricing Standards and Maximum Allowable Cost that will require the maximum allowable cost prices of drugs be updated at least every 7 days and disclosed in advance of their use. The MAC implementation requirements will be effective January 2016.