Showing posts with label regulation. Show all posts
Showing posts with label regulation. Show all posts

Friday, July 15, 2016

Prescription Drug Take-Back Programs - Proposed Regulation by CA Board of Rx


Heads-up!

The California State Board of Pharmacy will have the opportunity to discuss the future of the proposed regulation and determine what course of action it wishes to pursue.

View the draft modifications to the drug take-back regulation (pdf)

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Wednesday, May 21, 2014

The Differences Between The DSCSA, FDA Rules and Guidance - RxTrace

More great stuff that's clear and easy to understand from Dirk Rodgers. Follow the link below to read his full post.

The Differences Between The DSCSA, FDA Rules and Guidance - RxTrace:

"From reading the responses to the FDA docket requesting public feedback on standards for interoperable information exchange, I think it is time to review the difference between laws, FDA Rules and FDA guidance, like those stemming from the Drug Supply Chain Security Act (DSCSA).  It appears that some people might be confusing these a little."

'via Blog this'

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Thursday, January 16, 2014

What Are The FDA's CGMPs? Ramifications for Compounding Outsourcing Facilities

Updated February 4, 2026

Some of the links in the original post broke.

You might also be interested in:
---  the original post follows below  ---

On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), legislation that contains important provisions relating to the oversight of compounding of human drugs. In the new law, a compounder can become an “outsourcing facility.” Outsourcing facilities must comply with CGMP requirements. (Source:  FDA.gov - Compounding Quality Act - Title I of the Drug Quality and Security Act of 2013)

The FDA (Food and Drug Administration) puts forth the cGMP regulations (current good manufacturing practice). The CGMPs are also commonly referred to as:
  • GMP - good manufacturing practice, or
  • CGMPR (current good manufacturing practices regulations)
If you're unfamiliar with the FDA cGMPs, then consider taking this online course:
21 CFR 211: Pure, Safe, and Effective - an introduction to the FDA cGMPs

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Thursday, November 28, 2013

Obama signs Drug Quality and Security Act into law - SecuringIndustry.com


SecuringIndustry.com - Obama signs Drug Quality and Security Act into law:

"President Obama has signed H.R. 3204 into law, setting the wheels in motion for the FDA to develop a national track-and-trace system to secure the pharmaceutical supply chain.

The aim of the Drug Quality and Security Act (DQSA) is to "minimise opportunities for contamination, adulteration, diversion, or counterfeiting," whilst also clarifying the FDA's authority to regulate compounding pharmacies, according to the White House."

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Monday, November 18, 2013

Breaking news: US Senate clears track-and-trace bill - SecuringIndustry.com

SecuringIndustry.com - Breaking news: US Senate clears track-and-trace bill:

"The US Senate passed H.R. 3204 by unanimous voice vote today, bringing a national track-and-trace system for medicines and new laws governing compounding pharmacies to the brink of fruition.

With the House having given its blessing to H.R. 3204- also known as the Drug Quality and Security Act (DQSA) - at the end of September, all that remains now is for the bill to be passed to President Obama for signature."

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HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204 - FDA Law Blog

FDA Law Blog: HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204:

"With fingers crossed, attendees looked ahead to the future of track-and-trace. Panelists expressed that the national system will hopefully make it harder for bad actors to corrupt the integrity of the supply chain, as the current patchwork of state pedigree laws allows bad actors to shop around for more lenient states. It is hoped that this bill will put everyone on a level playing field and reduce loopholes."

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All Eyes On The U.S. Senate Tonight - RxTrace


Updated November 24, 2025

The original post didn't age well.

You might also be interested in:

---  the original post follows below  ---

Hold your breath. Let's see if the U.S. Senate will pass this bill, H.R. 3204 (An act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes.)

All Eyes On The U.S. Senate Tonight - RxTrace:

"There are lots of things that would be triggered by passage of the law. No doubt, the most important one is that the California pedigree law would immediately become inoperative. That is, all of the “clocks” in that law—like January 1, 2015 for 50% of all drugs being serialized and pedigreed, etc.—would stop and disintegrate into irrelevance along with those of all other state pedigree laws."

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Thursday, November 7, 2013

Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg

Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg:

"One lawmaker’s effort to alter Obamacare is holding up final action by Congress on legislation that would expand U.S. regulation of compounding pharmacies linked to meningitis deaths last year.

The Senate is poised to approve the measure to broaden the U.S. Food and Drug Administration’s oversight of compounding pharmacies. Ninety-nine senators have agreed to pass the legislation that the House passed without a roll call vote, Democratic and Republican lawmakers said.

Republican Senator David Vitter of Louisiana wants the vote on compounding pharmacies coupled with consideration of his proposal to deny lawmakers and their staffs employer contributions when they buy medical insurance on the exchanges set up under the new health-care law. As a result, senators may have to spend a week on work that could be done in minutes."

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Thursday, September 19, 2013

CA To Amend Track-and-Trace Law re: ‘Drop Shipments’

Updated October 2, 2025

The original link broke.

You can still read about the same topic here:
InBrief: California Proposes Breakthrough ePedigree Regulation On Drop Shipments - RxTrace
https://www.rxtrace.com/2013/09/inbrief-california-proposes-breakthrough-epedigree-regulation-on-drop-shipments.html/


---  the original post follows below  ---

California to amend track-and-trace law to deal with ‘drop shipments’:

"The proposal specifies that in the case of a drop shipment, the manufacturer would “omit data elements from the pedigree showing transfers of ownership to and from the wholesale distributor, including any certifications of receipt and delivery of the drug by the wholesaler.”

The electronic pedigree, however, would need to be “conveyed directly from the manufacturer to the authorized purchaser prior to or contemporaneously with the delivery” of the drug, according to the board."

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Friday, September 13, 2013

On-Line Change of Address Form - CA Board of Pharmacy

Updated June 12, 2026

The original links broke.

You can still go to the Change of Address form here:

Change of Address/Email/Name for a Personal License:
https://www.pharmacy.ca.gov/about/change_of_address_personal.shtml

---  the original post follows below  ---

Change of Address Form (online) - California Board of Pharmacy

The following link will take you to a webpage that gives an overview of the California laws and regulations governing Board of Pharmacy address change reporting requirements:

Board of Pharmacy - Technical Help:

"You are required to notify the board of any change in your address within 30 days. Change of address may be made on-line or in writing to the board."

If you are a licensed California Designated Representative, or other affected party, follow this link to the California Board of Pharmacy - On-line Change of Address Form.

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Training program for California Designated Representative (including 3PL) license applicants

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Wednesday, June 26, 2013

Saturday, May 25, 2013

Compounding A Crisis At FDA - Forbes Article


Updated October 14, 2025

You might also be interested in:

---  the original post follows below  ---

This is about legislative proceedings happening right now in Washington. Follow the link below to a short commentary.

Compounding A Crisis At FDA - Forbes:

"But all of this doesn’t change the fact that some “compounding” pharmacies are operating as drug makers under the guise of a pharmacy license, breaking existing law, and creating public risks. They are manufacturing drugs with none of the oversight that ensures that their processes are sterile and safe. FDA’s recent inspections of some of these facilities have surfaced widespread, and potentially dangerous biological contaminations of these products. Another tragedy is just a matter of time."

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Wednesday, March 27, 2013

CA Pedigree Law Exemptions

Purchase now to enroll in a California Designated Representative Training Course for:


---  the original post follows below  ---

Are Your Drugs Exempt From The California Pedigree Law?:
"Not all prescription drugs will need to comply with the California pedigree law on January 1, 2015 or 2016. In fact, there are a number of important exemptions that cover entire classes of certain drugs and certain types of transactions for all drugs. The volume of drug packages that could escape being serialized and pedigreed by those effective dates is not huge, but if you are a manufacturer or wholesaler, you should familiarize yourself with the list of exemptions. If you are lucky enough to make or handle any of the exempt drugs or transactions you might as well take advantage of your exemption." . . .   . . .

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Tuesday, March 26, 2013

FDA Considers Compounding Industry User Fees

Hamburg: User Fees Might be Solution for Funding Increasing Regulation of Compounding Industry:

Hamburg said in her blog posting that FDA "looks forward to working with Congress to explore funding mechanisms, which could include registration or other fees, as Congress has authorized and FDA has successfully implemented in other settings."

Such funding might be able to bridge the gap between agency goals and resource limitations. Left unclear, however, is whether the pharmaceutical compounding industry would be on board with the proposal. Past user fee proposals, such as the Prescription Drug User Fee Act, the Medical Device User Fee Act and the Generic Drug User Fee Act have all been passed with the explicit support of their respective industries.

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Saturday, March 23, 2013

Hamburg Says FDA Needs New Authorities to Regulate Pharmacy Compounding

Updated April 19, 2022

The original post didn't age well.

You can read more here:

---  the original post follows below  ---

FDA Must Have New Authorities to Regulate Pharmacy Compounding | FDA Voice:

"In the new framework, FDA believes that certain high-risk sterile compounding facilities should be subject to federal oversight to ensure that the compounding of sterile drug products at those facilities can be done without putting patients at undue risk, including . . .

And for all pharmacy compounding, FDA believes certain basic protections should be in place. These include . . ."

'via Blog this'

New Framework:
  • Require compliance with federal quality standards, appropriate for the compounding of riskier products & exposure of larger numbers of patients,
  • Require federal registration of the compounding facilities that will be subject to federal quality standards so FDA knows where they are and what drug products they are making.
  • Require those higher-risk compounding pharmacies to report to FDA serious adverse reactions to their drugs of which they become aware.
Basic Protections:
  • Grant clear authority to examine a pharmacy’s records to more quickly locate the cause of an outbreak or other violations of the law.
  • Prohibit compounding of the most complex and highest risk products—drugs and biologics that should only be made for patients by an FDA-registered drug manufacturer under an approved new drug application. 

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Monday, February 11, 2013

California Lawbook For Pharmacy - New - Free - Online

Updated January 1, 2026

The new California Lawbook For Pharmacy for the current year (pdf) has been posted by the CA Board of Pharmacy.

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Tuesday, June 5, 2012

New 2012 CA Rx Law - Security Prescription Forms for Controlled Substances

Updated November 20, 2025

The lawbook gets updated annually, so the page references change.

Here's the link to the current California Pharmacy lawbook:
http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf

HSC section 11162.1 is somewhere near page 743.

---  previous updates follow below  ---

Updated December 15, 2017

You might have also been looking for this, recently emailed out in a Nov 28, 2017 subscriber alert by the CA BOP.

"Background:

California Health and Safety Code section 11162.1 contains 14 elements that must appear on California Security Forms, the forms used to prescribe controlled substances in California*.  These elements were first enacted in 2003 when the triplicate prescription form was discontinued.  The law also requires that California Security Forms must be printed by CA Department of Justice licensed printers.  In 2006, the law was amended again to make several changes that took effect in January 2007.  Finally legislation enacted in 2011 required that the California Security Forms in use must be fully compliant with all requirements of the Health and Safety Code by July 1, 2012.

Here is a link to the required elements in the Health and Safety Code (go to page [718]):  http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf

In recent years, the board has continued to identify noncompliant California Security Forms in use that have been filled by California pharmacies, in violation of the Health and Safety Code requirements.  The board’s response upon identification of noncompliant forms having been used to dispense controlled drugs is to educate the licensee, and to cite and fine the pharmacy/pharmacists involved. Typically the licensing board for the prescriber is advised as well. 

Recently some pharmacies have begun to refuse to fill prescriptions written on noncompliant forms where item 11162.1(a)(10) is not fully compliant with the required elements.  One of these elements is “ Check boxes shall be printed on the form so that the prescriber may indicate the number of refills ordered.”  There are also additional elements missing on some forms, including lack of a watermark on the reverse of the form.   

The board recently has received complaints from patients or prescribers whose patients have been denied medication from the pharmacy because of the noncompliant forms.

Interim Solutions
  • Prescribers and dispensers need to become familiar with the 14 required elements of the security prescription  forms.
  • Prescribers with noncompliant forms should reorder compliant forms from a DOJ-licensed security printer.
  • Prescribers with noncompliant forms should consider using e-prescribing for controlled substances."

- -  the original post follows below  - -

This was just sent out by the California State Board of Pharmacy.  It's important enough, that you should stop to read this, and make sure your policies and procedures are in compliance with the new laws.

According to the Board:

This is a reminder about a new law taking effect July 1, 2012 regarding the required elements for security forms for controlled substances:

Effective January 1, 2012, security prescription forms for controlled substances must include the preprinted address of the prescriber (Health and Safety Code section 11162.1). Security prescription forms that do not have the preprinted address of the prescriber can be dispensed by the pharmacist until July 1, 2012. Prescription forms not in compliance are invalid and cannot be accepted on or after July 1, 2012.

Additionally, licensed health care facilities or clinics exempt under Section 1206 (those having 25 or more licensed physicians or surgeons preprinted on the form) are not required to preprint the category of licensure and license number of their facility or clinic (Health and Safety Code 11162.1[c][2]).

View all changes in Pharmacy Law that took effect in 2012 by using this link: http://www.pharmacy.ca.gov/laws_regs/new_laws.pdf

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Sunday, March 11, 2012

E-Pedigree Agenda Item - CA Pharmacy Board Meeting 3-21-2012

Updated 4/19/2012 with the following:

The CA Board of Pharmacy just emailed this out:

"On behalf of the Board of Pharmacy, the Department of Consumer Affairs today added to its website the webcast of its March 21, 2012 Enforcement Committee/e-Pedigree Meeting.  At this meeting, presentations were made by FDA and multiple supply chain members.  . . .

To view the webcast of the March 21, 2012 meeting go to:
http://www.dca.ca.gov/publications/multimedia/pharm_20120321.wmv  "


Note:  I hope you've got patience with the wmv download.  I didn't have 2 hours worth of patience to wait for the download.

- - - - original post follows - - - -

According to this California Board of Pharmacy NOTICE OF MEETING AND AGENDA - Enforcement Committee and E‐Pedigree Public Meeting - March 21, 2012:

Here's what's listed under this agenda item, Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Medication:

a. Discussion about the Presence of Counterfeit Avastin in California Physician Offices
b. Presentation and Discussion of a Proposal for Federal Legislation by the Pharmaceutical Distribution Security Alliance
c. Presentation by Connie T. Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Center for Drug Evaluation and Research, US Food and Drug Administration
d. Presentations and Questions from the Pharmaceutical Supply Chain on Their Readiness to Meet California’s Staggered E‐Pedigree Implementation Schedule 1. Kimberly Fleming, Senior Manager, Product Security, EMD Serono, Inc, 2. Robert Celeste, Director, Healthcare, GS1 US 3. Other Companies, Associations and Other Entities Wishing to Address the Committee on E‐Pedigree Issues
e. General Discussion
f. Discussion and Possible Action to Develop Regulation Requirements Specifying a Unique Identification Number for Prescription Medication Pursuant to California’s E‐Pedigree Requirements
f. Discussion and Possible Action to Develop “Grandfathering” Provisions for Non‐Pedigreed Dangerous Drugs Pursuant to section 4163.2 of the Business and Professions

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Thursday, January 12, 2012

California Pharmacy Law Book - New!

SkillsPlus International Inc. is the ONLY training provider approved by the Califo
rnia State Board of Pharmacy to offer California Designated Representative training programs for wholesalers, 3PL, and reverse distributors. Sign-up for a California Designated Representative course now:
Updated March 9, 2026:

California Pharmacy Law Book with Rules and Regulations

It's here! Hot off the press, the latest edition:


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---------------------

California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy
California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy


Monday, November 14, 2011

California Board of Pharmacy - Laws and Regulations

Updated October 16, 2023

The new laws for 2012 document is no longer available.

You might also be interested in:


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