FDA

CONNECTED DEVICES IN HEALTHCARE FDA LAWS: CLINICAL GRADE WEARABLES FOR IMPROVING PATIENT OUTCOMES

By Al Mohajerian | October 10, 2017

December 4-5, 2017 • Westin San Diego • San Diego, CA

Overview of FDA Regulatory Compliance Requirements — Spotlight on
Wearable Devices

  • Overview of FDA regulatory compliance requirements of wearable devices including hearing aids, defibrillator vests, radiation- emitting devices, watches, glasses and shoes
  • Medical device registration and FDA tracking
  • Risk-benefit analysis, preclinical studies, biocompatibility and biological evaluation
  • Classification, premarket submission

Al Mohajerian, Mohajerian APLC

http://www.cbinet.com/sites/default/files/brochures/fc17214_brochure.pdf

Filed Under: FDAHealthcarePharmaceuticals

IS A 503(B) PHARMACY ALLOWED TO PREPARE PATIENT SPECIFIC MEDICATIONS?

By Al Mohajerian | July 3, 2016

Under the FDA rules, the answer is yes:

21 U.S.C. 353b provides, inter alia, 

“(d)(4)(A) The term “outsourcing facility” means a facility at one geographic location or address that–

(i) is engaged in the compounding of sterile drugs;

(ii) has elected to register as an outsourcing facility; and

(iii) complies with all of the requirements of this section.

(B) An outsourcing facility is not required to be a licensed pharmacy.

(C) An outsourcing facility may or may not obtain prescriptions for identified individual patients. (emphasis added)”

“….Section 503(b) establishes ‘Outsourcing Facilities.’ Outsourcing facilities can provide compounded sterile drugs without patient-specific prescriptions. “Outsourcing facilities can provide patient-specific and non-patient-specific medications.”1

“Section 503(a) applies to pharmacies that compound patient-specific prescriptions, such as patient-specific intrathecal medications…. Pharmacies that practice under this business model are regulated by their respective State Boards of Pharmacy2.

“State regulations can also complicate the definition of whether pharmacies are in compliance with “patient-specific” only when compounding for one patient…” 3”

Last in February 2015, in the California legislature, Senator Mike Morell introduced

Senate Bill 619, which was sponsored by the California Board of Pharmacy. This Senate Bill has not been enacted into law. On February 1, 2016, Senate Bill 619 was returned to the Secretary of the Senate, pursuant to Joint Rule 56.4 If it had been enacted, it would have prevented a 503(b) pharmacy from preparing patient specific medications.

Senate Bill 619 has passed the California Senate but it has not been enacted into law. The Bill stated: “California licensing requirements for a new category of prescription drug compounding entity called an outsourcing facility. This bill will prohibit a licensed outsourcing facility from filling patient specific prescriptions. This bill will create new licensure requirements, specific to the state of California, for in state and out of state outsourcing facilities doing business within and across state lines. These new requirements will prohibit an outsourcing facility to be located in the same licensed premises as a pharmacy, therefore only allowing outsourcing facilities to distribute compounded drugs for non-patient specific prescriptions. Since the FDA has yet to release specific federal requirements for outsourcing facilities, this bill anticipates future federal requirements and creates California specific standards by which licensed outsourcing facilities must comply.5” 

Although this Senate Bill is not enacted into law, it could be enacted soon.

The Board of Pharmacy in California will continue to seek to regulate outsourcing facilities or 503(b) facilities.

In conclusion, 503(b) pharmacies or outsourcing facilities may under the FDA rules legally prepare patient specific medications. Consult with our firm or your counsel before making any decisions as the law in this field keeps changing. This article is designed for general information only. The information presented should not be construed to be formal legal advice nor the formation of a lawyer/client relationship

1 Hartley Medical, “Revisiting HR3204: the Drug Quality and Security Act of 2013”, William Stuart.

2 Hartley Medical, “Revisiting HR3204: the Drug Quality and Security Act of 2013”, William Stuart.

3 Pharmaceutical North America, Inc. “What is Patient-Specific Compounding? The Gray Areas may Surprise Pharmacists, February 16, 2016.

4 Joint Rules of the Senate and Assembly, 2015-2016 Regular Session,4 Joint Rule 56 states: “Bills introduced in the first year of the regular session and passed by the house of origin on or before the January 31st constitutional deadline are ‘carryover bills.”” Immediately after January 31, bills introduced in the first year of the regular session that do not become “carryover bills” shall be returned to the Chief Clerk of the Assembly or Secretary of the Senate, respectively. Notwithstanding Rule 4, as used in this rule “bills” does not include constitutional amendments,” Joint Rule 4 states: “Whenever the word “bill” is used in these rules, it includes any constitutional amendment, any resolution ratifying a proposed amendment to the United States Constitution, and any resolution calling for a constitutional convention.”

5 Senate Bill 619 on outsourcing facilities.

Filed Under: FDAHealthcarePharmaceuticals

PROHIBITION ON WHOLESALING BY COMPOUNDING PHARMACIES

By Al Mohajerian | July 3, 2016

21 USC 353b provides, inter alia:

“(a) In general Sections 352(f)(1), 355, and 360eee-1 of this title shall not apply to a drug compounded by or under the direct supervision of a licensed pharmacist in a facility that elects to register as an outsourcing facility if each of the following conditions is met:

(8) Prohibition on wholesaling
The drug will not be sold or transferred by an entity other than the outsourcing facility that compounded such drug. This paragraph does not prohibit administration of a drug in a health care setting or dispensing a drug pursuant to a prescription executed in accordance with section 353(b)(1) of this title.

(d) Definitions:
4)(A) The term “outsourcing facility” means a facility at one geographic location or address that–
(i) is engaged in the compounding of sterile drugs;
(ii) has elected to register as an outsourcing facility; and
(iii) complies with all of the requirements of this section.
(B) An outsourcing facility is not required to be a licensed pharmacy.
(C) An outsourcing facility may or may not obtain prescriptions for identified individual patients.
(5) The term “sterile drug” means a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under Federal or State law.”

“Pharmacies cannot compound medications or dosage forms that are commercially available and they cannot sell compounded products to other pharmacies for resale. A pharmacy may, however, sell a compounded product to a practitioner or an institutional pharmacy if it is to be administered to patients in the practitioner’s office or institution.”

“Although an outsourcing facility may send prescription drugs to health care facilities without obtaining prescriptions for identified individual patients, drugs produced by outsourcing facilities remain subject to the requirements in section 503(b) of the FD&C Act. Therefore, an outsourcing facility cannot dispense a prescription drug to a patient without a prescription. ”

By Al Mohajerian | Published April 29, 2016 | Posted in FDA  | Tagged 21 USC 353bcompounding pharmaciesProhibition on wholesaling |

Filed Under: FDAPharmaceuticals

A STERILE COMPOUNDING PHARMACY LICENSE

By Al Mohajerian | July 3, 2016

Violation of California Regulations

Cal. Bus. & Prof. Code § 4300 provides, inter alia,

(a) A pharmacy shall not compound sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board pursuant to this section. The license shall be renewed annually and is not transferable.
(b) A license to compound sterile drug products shall be issued only to a location that is licensed as a pharmacy and shall be issued only to the owner of the pharmacy licensed at that location.

California makes clear that compounding limitations include: a valid prescription for an individual patient, a limited quantity, of not more than a 72 hour supply, and retail pharmacies are excluded.

16 CFR §1735.2. Compounding Limitations and Requirements, provides:
(a) Except as specified in (b) and (c), no drug product shall be compounded prior to receipt by a pharmacy of a valid prescription for an individual patient where the prescriber has approved use of a compounded drug product either orally or in writing. Where approval is given orally, that approval shall be noted on the prescription prior to compounding.
(b) A pharmacy may prepare and store a limited quantity of a compounded drug product in advance of receipt of a patient-specific prescription where and solely in such quantity as is necessary to ensure continuity of care for an identified population of patients of the pharmacy based on a documented history of prescriptions for that patient population.
(c) A “reasonable quantity” as used in Business and Professions Code section 4052(a)(1) means that amount of compounded drug product that:
(1) is sufficient for administration or application to patients in the prescriber’s office, or for distribution of not more than a 72-hour supply to the prescriber’s patients, as estimated by the prescriber; and
(2) is reasonable considering the intended use of the compounded medication and the nature of the prescriber’s practice; and
(3) for any individual prescriber and for all prescribers taken as a whole, is an amount which the pharmacy is capable of compounding in compliance with
pharmaceutical standards for integrity, potency, quality and strength of the compounded drug product.
(f) The pharmacist performing or supervising compounding is responsible for the integrity, potency, quality, and labeled strength of a compounded drug product until it is dispensed.
h) Health care entity means any person that provides diagnostic, medical, surgical, or dental treatment, or chronic or rehabilitative care, but does not include any retail pharmacy or any wholesale distributor. Except as provided in § 203.22(h) and (i) of this chapter, a person cannot simultaneously be a “health care entity” and a retail pharmacy or wholesale distributor.

By Al Mohajerian | Published April 29, 2016 | Posted in Uncategorized  | Tagged 16 CFR §1735.2compound sterile drug productscompounding pharmacy license |

Filed Under: FDAHealthcarePharmaceuticals

Tagged With: Compounding Pharmacy

HEALTHCARE COMMON PROCEDURE CODING SYSTEM

By Al Mohajerian | July 3, 2016

HEALTHCARE COMMON PROCEDURE CODING SYSTEM

Healthcare Common Procedure Coding system

“The Healthcare Common Procedure Coding System (HCPCS, often pronounced by its acronym as “hick picks”) is a set of healthcare procedure codes based on the American Medical Association’s Current Procedure Terminology (CPT).  Initially, use of the HCPCS codes was voluntary, but with the implementation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which required that CMS [Center for Medicare and Medicaid Services] use HCPCS for transactions involving healthcare information, the HCPCS codes became mandatory.”[1] 

“HCPCS codes are numbers that Medicare assigns to every task and service a medical practitioner may provide to a patient including medical, surgical and diagnostic services.”[2]

HCPCS includes three levels of codes:

Level I Codes consists of a five-digit numeric code that contains the American Medical Association’s Current Procedural Terminology (CPT).”[3]

“Level I of the HCPCS is comprised of Current Procedural Terminology (CPT-4) , a numeric coding system maintained by the American Medical Association (AMA). The CPT-4 is a uniform coding system consisting of descriptive terms and identifying codes that are used primarily to identify medical services and procedures furnished by physicians and other healthcare professionals. These healthcare professionals use the CPT-4 to identify services and procedures for which they bill public or private health insurance programs. Level I of the HCPCS, the CPT-4 codes, does not include codes needed to separately report medical items or services that are regularly billed by suppliers other than physicians.”[4]

Issues related to the application of Level I HCPCS codes (CPT-4) for physicians will be referred to the AMA.[5]”  “The AMA maintains the CPT codes, updates them routinely, and holds the copyright on the CPT codes.[6] 

Level II Codes are alphanumeric and primarily include non-physician services such as ambulance services and  prosthetic devices, orthotics, and supplies (DMEPOS) and represent items and supplies and non-physician services, not covered by CPT-4 codes (Level I).  Level II codes are referred to as alpha-numeric codes because they consist of a single alphabetical letter followed by 4 numeric digits, while CPT codes are identified using 5 numeric digits.” [7]

“Level II of the HCPCS is a standardized coding system that is used primarily to identify products, supplies, and services not included in the CPT-4 codes, such as ambulance services and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) when used outside a physician’s office. Because Medicare and other insurers cover a variety of services, supplies, and equipment that are not identified by CPT-4 codes, the level II HCPCS codes were established for submitting claims for these items.[8]”  These codes are for the use of all private and public health insurers.

 “CMS has the authority to assign HCPCS codes.  HCPCS Level II codes are maintained by the CMS HCPCS Workgroup. Since HCPCS is a national coding system, all payers will be represented in the Workgroup including representatives of the private insurance sector; CMS staff and contractors; representatives of state Medicaid agencies and of the US, DHHS Department of Veteran’s Affairs.[9] The Workgroup includes representatives from private insurance companies, Medicaid, and the Pricing, Data Analysis and Coding Contractor (PDAC). The Workgoup is responsible for all revisions, deletions and additions to the HCPCS codes.”[10]   These representatives will participate in the workgroup meetings and provide input as to what is necessary to meet each party’s program operating needs.[11]

“Level III codes, also called local codes, were developed by state Medicaid agencies, Medicare contractors, and private insurers for use in specific programs and jurisdictions. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) instructed CMS to adopt a standard coding systems for reporting medical transactions. The use of Level III codes was discontinued on December 31, 2003, in order to adhere to consistent coding standard.[12]

[1]. National Assistive Technology Advocacy Project, HCPCS Codes, Diana M. Straube, Staff Attorney, November 2008.

[2] About Health, What are Medicare’s HCPCS Codes.

[3] National Assistive Technology Advocacy Project, HCPCS Codes, Diana M. Straube, Staff Attorney, November 2008.

[4] CMS.gov, Centers for Medicare & Medicaid Services, HCPCS Coding Questions, Do you have a Coding Question.

[5] CMS.gov, Centers for Medicare & Medicaid Services, HCPCS Coding Questions, Do you have a Coding Question.

[6] About Health, What are Medicare’s HCPCS Codes.

[7] Healthcare Common Procedure Coding System (HCPCS) Level II Coding Procedures, November 13, 2015.

[8] CMS.gov, Centers for Medicare & Medicaid Services, HCPCS Coding Questions, Do you have a Coding Question.

[9] Healthcare Common Procedure Coding System (HCPCS) Level II Coding Procedures.

[10]National Assistive Technology Advocacy Project, HCPCS Codes, Diana M. Straube, Staff Attorney, November 2008

[11] Healthcare Common Procedure Coding System (HCPCS) Level II Coding Procedures.

[12] National Assistive Technology Advocacy Project, HCPCS Codes, Diana M. Straube, Staff Attorney, November 2008.

By Al Mohajerian | Published May 2, 2016 | Posted in FDA  | Tagged American Medical AssociationCPT codesHCPCSHealthcare Common Procedure Coding systemNational Assistive Technology Advocacy Project 

Filed Under: FDAHealthcareNDCPharmaceuticals